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Study Objectives This is a retrospective observational study of epidemiological surveillance, multicenter, non-profit, spontaneous, Italian on patients submitted to allo-HSCT among Italian Transplant Centers GITMO. This study will evaluate all consecutive adult patients who received novel drugs after hematopoietic stem cell transplantation from related and unrelated donors between January 1, 2009 to December 31, 2018 in GITMO-affiliated Centers. This study will evaluate approximately 300 subjects (with competitive enrolment) from GITMO investigational centers. Conditions: Multiple Myeloma, Stem Cell Transplant Location: Italy Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria Written and signed study informed consent Multiple myeloma Allogeneic transplantation from related - HLA identical Allogeneic transplantation from volunteer unrelated donor allogeneic transplantation from haploidentical related donor Myeloablative or reduced intensity conditioning regimen Exclusion Criteria Second or further allogeneic transplant Plasma cell leukemia Non measurable disease

Study Objectives The purpose of this trial is to estimate overall response rate (ORR) of SHR-1210 combined with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Conditions: Gastric Cancer, GastroEsophageal Cancer Intervention / Treatment: BIOLOGICAL: SHR-1210, DRUG: Capecitabine, DRUG: Oxaliplatin, DRUG: Apatinib Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ). * Age >= 18 years old, male or female. * NO previous therapy for advanced/metastatic disease of GC/GEJ (including HER2 inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled. * Has measurable disease per RECIST 1.1. * Life expectancy >= 12 weeks. * Eastern Cooperative Group (ECOG) performance status of 0 to 1. * Has adequate organ function. * Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. Exclusion Criteria: * Has known HER2-positive status. * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or a VEGFR inhibitor. * Has known active central nervous system metastases. * Has received a live vaccine within 4 weeks prior to the first dose of study treatment. * With any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded. * Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention. * Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg. * Coagulation abnormalities (INR > 1.5 or APTT > 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.

Study Objectives The present primary therapy of cervical intraepithelial neoplasia (CIN) grade 3 and persistent CIN 2 represents conisation. Surgical treatment can cause perioperative (infection, bleeding in in 5-10%) and postoperative (increased risk of preterm labor) complications, as well as incomplete resections (20%) and risk of recurrence in 5-17%. Imiquimod is an immunomodulating drug, that has been reported to be effective in human papilloma virus-related disease, such as vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), and anal intraepithelial neoplasia (AIN). The present randomised, placebo controlled, double blind study evaluates the efficacy of a topical treatment with imiquimod for 16 weeks in 60 patients with histologically confirmed CIN 2/3. Conditions: Cervical Intraepithelial Neoplasia Intervention / Treatment: DRUG: Topical imiquimod therapy Location: Austria Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Caucasian women aged 18 years and older with proven HPV-associated CIN 2/3 * Colposcopy with fully visible transformation zone and lesion * Safe Contraception * Signed Informed Consent * Negative urine pregnancy test * Able to communicate well with the investigator, to understand and comply with the requirements of the study * Signed the written informed consent Exclusion Criteria: * Women who are pregnant or lactating or become pregnant during the conduct of the study * Symptoms of a clinically relevant illness in the 3 weeks before the first study day * History of hypersensitivity to the trial drug or to drugs with a similar chemical structure * Participating in another clinical trial within 30 days * Malignancy * Immunosuppression (medication, illness) * HIV- or Hepatitis infection

Study Objectives This is an exploratory prospective translational multicentre study. Melanoma is the 5th most common cancer diagnosed in Ireland and its incidence among women and men is above the European average. Following treatment the elimination of cancer cells ultimately occurs by the activation of apoptotic cell death pathways. The SYS-ACT approach builds on a combination of mathematical systems of modelling, quantitative biochemistry and cell biology, and specifically predicts the drug responsiveness of melanoma cell lines to various apoptosis-inducing treatments. The investigators propose to validate the SYS-ACT approach and application in a translational systems medicine study. Conditions: Advanced Melanoma, Metastatic Melanoma Location: Ireland Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients >= 18 years of age. * Patient must be able to give own signed informed consent. * Patients that present with advanced or metastatic (stage III/IV) malignant melanoma of the skin. * Patients that are planned to receive either: * Adjuvant treatment * 1st line treatment for metastatic disease * 2nd line treatment for metastatic disease * Patients with prior adjuvant treatment are allowed. * Patients receiving planned standard treatment of one or more of the following: * Chemotherapy regimens containing DTIC, TMZ and/or cisplatin * Immunotherapy (for example ipilimumab and/or anti-PD-L1/PD-1 therapies) * BRAF and/or MEK inhibitors * Patients were FFPE and fresh frozen tissue is available (both mandatory). Exclusion Criteria: *

Study Objectives Tumor response to NAC predicts survival and can be considered a surrogate prognostic marker. Three tiered chemotherapy response score (CRS) of omental tissue sections showed a significant association with survival. In patients with CRS 1 or 2, NAC selects a subpopulation of chemotherapy resistant tumor cells. This study will examine comprehensive molecular analyses on the residual disease of 104 clinically defined high-grade serous carcinoma after NAC, including next-generation sequencing on 14 matched pretreatment biopsies. This information together with immune marker expression and BRCA expression, will provide a unique opportunity to guide biomarker-driven adjuvant studies targeting these chemotherapy-resistant tumor cells. Conditions: Advanced-stage Ovarian Cancer Intervention / Treatment: DRUG: chemotherapy Location: Korea, Republic of Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * patients with pathologically confirmed epithelial ovarian cancer who received at least 1 cycle of neoadjuvant chemotherapy * The patient inclusion criteria included 1) high grade serous carcinoma 2) stage III/IV disease 3) availability of clinical data and tumor tissue 4) viable residual tumors after neoadjuvant chemotherapy. Exclusion Criteria: * patients with complete pathologic response (CRS 3) as IHC staining was insufficient or unavailable

Study Objectives This protocol corresponds to an open-label national phase II, multicenter, to assess efficacy (in terms of response rate and CR) and toxicity of bendamustine, bortezomib and prednisone (BVP) in 60 patients newly diagnosed MM. Patients in the absence of disease progression or unacceptable toxicity receive up to 9 cycles of BVP. The patients eligible for autologous transplant receive four cycles of BVP, hematopoietic stem cell collection and administration of two cycles BVP over followed by autologous transplant. In addition to the overall response rates, will also be analyzed time to progression (TTP), progression-free survival (PFS) and overall survival. Finally, the results will be compared with BVP with those obtained in 120 patients included in our protocol VMP GEM10MAS65. Patients will be evaluated at scheduled visits up to 3 periods of study: pretreatment, treatment and monitoring. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Bendamustine, DRUG: Velcade, DRUG: Prednisone Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient age greater than or equal to 18 at the time of signing Informed consent * Patient who has voluntarily signed informed consent before conduct of the trial any evidence that is not part of care normal patients, with the knowledge of the patient that can leave the trial at any time he want * Patient able, in the opinion of the physician to comply with the visitation schedule and other requirements of the protocol * Patient newly diagnosed symptomatic multiple myeloma based on standard criteria and has not received any previous treatment of chemotherapy for MM. * Patients with newly diagnosed multiple myeloma, secretory, or oligosecretor or not secretor if it has soft tissue plasmacytomas. * Patients with non-secretory MM oligosecretor or without white tissue plasmacytomas be excluded to keep a group of patients with characteristics similar to the previous study with which we compare the results. * Patients with measurable disease, defined by the following criteria: For MM secreting measurable disease is defined as any value quantifiable serum monoclonal protein (>= 1g/dl) and where applicable, a light chain excretion in urine >= 200 mg/24 hours. For Multiple Myeloma oligosecretor or secreting measurable disease defined by the presence of soft tissue plasmacytomas (not bone) determined by clinical examination or radiographic methods (eg MRI, CT-Scan) * ECOG PS <= 2 * Expectations of life than 3 months. * The patient has the following laboratory values within 28 days before the baseline visit: Platelet count >= 100 x 109 / L, hemoglobin >= 8.0g/dL and absolute neutrophil count (ANC) >= 1.5 x 109 / L; allowed counts under if they are clearly due to a bone marrow infiltration by MM. Corrected serum calcium <14mg/dL. Aspartate transaminase (AST) <= 2.5 x upper limit of normal(LSN) Alanine aminotransferase (ALT) <= 2.5 x ULN Total bilirubin within normal limits Serum creatinine <2 mg / dL * Patients of childbearing potential must use effective contraception during duration of the study and up to 6 months after completion of treatment Exclusion Criteria: * Patient has previously received treatment for multiple myeloma with Pulse steroids except for some emergency that requires it before start of induction therapy, administration of bisphosphonates or radiation therapy, or analgesic due to the presence of plasmacytomas, which require it for some urgency. * Patients with non-measurable disease. * Patient with peripheral neuropathy grade ³ 2 within 14 days prior to its inclusion in the trial * Patients with hypersensitivity to bortezomib, boric acid, or bendamustine mannitol * Patient to be known carrier of the virus HIV (human immunodeficiency) surface antigen of hepatitis B virus or who has active infection virus hepatitis C. * Patient who has had a myocardial infarction within 6 months prior to inclusion in the clinical trial or has a functional class III or IV according to the New York Heart Association (NYHA) heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias or acute ischemia detected electrocardiographically or conduction system disorders. * Patient who has received any investigational agent within 30 days prior their inclusion or is currently in another clinical trial or receiving any investigational agent * Patient undergoing major surgery within 30 days before inclusion in the study * Patient pregnant or breastfeeding * Patients with acute diffuse infiltrative pulmonary disease and / or disease pericardium * History of other malignancies after different myeloma (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) to unless the patient is free of the disease beyond 5 years * Hypertension arterial or poorly controlled diabetes mellitus or any other disease severe organ involving an unreasonable risk to the patient * Any psychiatric disorder that interferes with comprehension of consent informed or prevent the normal discharge that requires participation in this trial * Patients with major psychiatric history.

Study Objectives The OvIP1 study is designed to examine how drug dose and perfusion temperature affect the pharmacokinetics and pharmacodynamics of cisplatin used as (hyperthermic) intraperitoneal chemoperfusion, as an adjunct to surgery, in women with stage III epithelial ovarian cancer. Conditions: Ovarian Cancer, Primary Peritoneal Cancer Intervention / Treatment: PROCEDURE: Cytoreductive surgery, DRUG: IPEC with Cisplatin (75mg/m²), DRUG: IPEC with Cisplatin (100mg/m²), DRUG: Hypertherm IntraPEritoneal Chemotherapy with Cisplatin (75mg/m²), DRUG: HIPEC with Cisplatin (100mg/m²) Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Tumor type: * Biopsy proven serous epithelial ovarian carcinoma or peritoneal carcinoma * Primary or recurrent disease * Extent of disease: * Positive retroperitoneal lymph nodes and /or microscopic metastasis beyond the pelvis (FIGO stage III, Appendix (47)) * Stage IV with unilateral pleural fluid allowed * Complete or nearly complete macroscopic cytoreduction at the time of surgery (CC-0 or CC-1) deemed possible based on imaging, laparoscopy, or both * Second-line patients; platinum sensitive * Age over 18 years * No major cardiac or respiratory disease * Adequate performance status (Karnofsky index > 70%) * Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent * Expected life expectancy more than 6 months * Laboratory data: * Serum creatinine <= 1.5 mg/dl or a calculated Glomerular Filtration Rate (GFR) (CKD-EPI) >= 60 mL/min/1.73 m2 * Serum total bilirubin <= 1.5 mg/dl, except for known Gilbert's disease * Platelet count > 100.000/µl * Hemoglobin > 9g/dl * Neutrophil granulocytes > 1.500/ml * International Normalized Ratio (INR) <= 2 * Absence of alcohol and/or drug abuse * No other concurrent malignant disease * No inclusion in other clinical trials interfering with the study protocol * No concurrent chronic systemic immune or hormone therapy, except neoadjuvant chemotherapy * Absence of any severe organ insufficiency * No pregnancy or breast feeding * Written informed consent Exclusion Criteria: * Severe or uncontrolled cardiac insufficiency, including recent (< 6 months) occurrence of myocardial infarction, the presence of congestive cardiac insufficiency, of symptomatic angor in spite of optimal medical care, of cardiac arrhythmia requiring medical treatment presenting insufficient rhythm control, or uncontrolled arterial hypertension * Pregnancy or breast feeding * Platinum resistant or refractory disease * Active bacterial, viral or fungal infection * Active gastro-duodenal ulcer * Parenchymal liver disease (any stage cirrhosis) * Uncontrolled diabetes mellitus * Severe obstructive or restrictive respiratory insufficiency * Psychiatric pathology capable of affecting comprehension and judgment faculty * Tumor in the presence of obstruction * Evidence of extra-abdominal disease (with the exception of unilateral malignant pleural effusion) or extensive liver metastasis

Study Objectives The purpose of this clinical trial is to study Edotecarin in patients with the brain tumor glioblastoma multiforme (GBM) who have progression or first recurrence following initial treatment with surgery, radiation and chemotherapy. Conditions: Glioblastoma Intervention / Treatment: DRUG: Edotecarin, DRUG: Temozolomide, DRUG: Carmustine (BCNU), DRUG: Lomustine (CCNU) Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Must have biopsy-proven GBM. First relapse (progression or recurrence) of GBM after surgery (or biopsy) and treatment with radiotherapy (conventional fractionated external beam) and chemotherapy (temozolomide- or nitrosurea-based therapy) * Must have past biopsy samples available for central pathology review * Must have evidence on Gd-MRI of progressive/recurrent disease * Must have measurable disease on Gd-MRI obtained within 14 days prior to start of study treatment * Must be at least 18 years of age * Must have a Karnofsky Performance Status score of at least 70 * If being treated with steroids, the steroid dose must be stable or decreasing for 1 week prior to randomization * If being treated with anticonvulsants, must have no change in the type of anticonvulsants for 2 weeks prior to randomization * All acute toxic effects (except for alopecia) of any prior treatment must have resolved or are no greater than grade 1 (NCI Common Toxicity Criteria, Version 2.0) * Baseline laboratory data must be within the following limits: absolute neutrophil count at least 1500; platelets at least 100,000; hemoglobin at least 9.0 g/dL; serum creatinine no greater than 1.5 mg/dL, total serum bilirubin no greater than 1.5 times the upper limit of the normal range; SGOT and SGPT no greater than 2.5 times the upper limit of the normal range; albumin at least 3.0 g/dL, serum or urine pregnancy test (for females of childbearing potential) negative within 7 days prior to start of study treatment * At least 6 weeks must have elapsed since completion of prior nitrosurea therapy; at least 4 weeks since completion of prior temozolomide therapy * Must have written informed consent * Must be able and willing to comply with study procedures * &#9;Must have received prior treatment with radiotherapy (conventional fractionated external beam) and (neo)adjuvant/concurrent chemotherapy (with a temozolomide- or a nitrosurea-based containing )regimen for GBM Exclusion Criteria: * Must not have received prior treatment (except for surgical debulking) of first relapse (progression or recurrence) of GBM * Must not have received prior treatment with another topoisomerase-I inhibitor (e.g. irinotecan, topotecan, rubitecan) * Must not have had radiosurgery or radiotherapy within 1 month prior to randomization * Must not have had prior brachytherapy or chemotherapy wafer implantation * Must not have had prior high-dose chemotherapy with bone marrow or stem cell support * Must not receive concomitant treatment with any other investigational agent or anti-cancer treatment during the study * Must not be currently enrolled in another therapeutic clinical trial for the treatment of GBM * Must not currently (or in the past 5 years) have other malignancies (except for adequately treated basal cell or squamous cell skin cancer or non-invasive cervical cancer) * Must not have any of the following in the past 6 months: myocardial infarction (heart attack), severe/unstable angina, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident (stroke), or transient ischemic attack (TIA) * Must not have had any of the following in the past 2 months: pulmonary embolus (blood clot in lungs), deep venous thrombosis (blood clot in veins), or other significant thromboembolic event * Must not have an ongoing cardiac dysrhythmia (abnormal heart rhythm) of grade 2 or higher (NCI Common Toxicity Criteria, Version 2.0) * Must not have known human immunodeficiency virus (HIV) infection * Must not be pregnant or breastfeeding. Patients (male and female) must be surgically sterile (or postmenopausal for females) or must agree to use effective contraception during the period of study treatment * Must not be inappropriate for entry into the study, in the judgment of the investigator

Study Objectives RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth of urothelial cancer. PURPOSE: This randomized phase I trial is studying how well low-dose interferon alfa works in treating patients with cancer of the urothelium. Conditions: Bladder Cancer, Urethral Cancer Intervention / Treatment: BIOLOGICAL: Recombinant Interferon Alfa Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologically proven urothelial cancer, known or suspected (e.g. by outside evaluation) to be muscle-invasive, and be scheduled for cystoscopy and transurethral biopsy as part of their routine evaluation at M. D. Anderson. * Patients must understand the investigational nature of this study and provide written, informed consent. Exclusion Criteria: * Patients who are pregnant or lactating are not eligible. Women of child-bearing potential must have a negative pregnancy test before starting therapy. * Patients with current symptoms suggestive of clinically significant affective disorder. * Patients taking more than physiologic replacement doses of corticosteroids are not eligible.

Study Objectives The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy. Conditions: Malignant Solid Tumors Intervention / Treatment: DRUG: PEG-rhG-CSF Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: PREVENTION Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with age >= 18 years * diagnosis of lung cancer,head and neck cancer,colorectal cancer,ovarian cancer * Karnofsky Performance Status >= 70 * life expectancy of at least 3 months * Written informed consent are acquired Exclusion Criteria: * uncontrolled infection,Temperature is 38.0 ℃ or higher * pregnancy * Other situations that investigators consider as contra-indication for this study

Study Objectives The purpose of this study is to investigate whether endostar (recombinant human endostatin)with cisplatin and capecitabine (Xeloda) as 1st line treatment in the advanced gastric cancer is effective and safe. Conditions: Advanced Gastric Cancer Intervention / Treatment: DRUG: endostar, cisplatin, capecitabine, DRUG: capecitabine, DRUG: cisplatin Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Having signed informed consent * Age 18 to 70 years old * Histologically confirmed gastric adenocarcinoma * Unresectable recurrent or metastatic disease * Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months * Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months. * Measurable disease according to the RECIST criteria * Karnofsky performance status >=60 * Life expectancy of >=2 month * No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks * ALT and AST<2.5 times ULN (<=5 times ULN in patients with liver metastases) * Serum albumin level >=3.0g/dL * Serum AKP < 2.5 times ULN * Serum creatinine <ULN, and CCr < 60ml/min * Bilirubin level < 1.5 ULN * WBC>3,000/mm3, absolute neutrophil count >=2000/mm3, platelet>100,000/mm3, Hb>9g/dl Exclusion Criteria: * Brain metastasis (known or suspected) * Previous systemic therapy for metastatic gastric cancer * Inability to take oral medication * Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy * Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry * Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on. * Allergic constitution or allergic history to protium biologic product or any investigating agents. * Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension. * Pregnancy or lactation period * Any investigational agent within the past 28 days * Other previous malignancy within 5 year, except non-melanoma skin cancer * Previous adjuvant therapy with capecitabine+platinum, * Pre-existing neuropathy>grade 1 * Legal incapacity

Study Objectives The purpose of this study is to determine whether CO-1.01 is safe and effective for treating metastatic pancreatic cancer that did not respond to gemcitabine. Conditions: Metastatic Pancreatic Adenocarcinoma Intervention / Treatment: DRUG: CO-1.01 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Gemcitabine-refractory metastatic ductal adenocarcinoma of the pancreas * At least 1 measurable lesion according to RECIST 1.1 criteria * Computerized tomography (CT) scan <= 28 days prior to CO-1.01 * First-line treatment included at least 3 doses of gemcitabine (as monotherapy or combination therapy) with the last dose administered at least 2 weeks prior to CO 1.01 * Radiological best response of disease progression after 1st-line treatment (no radiological stable disease or better allowed at any time) * Patients who experienced progressive disease during (neo)-adjuvant gemcitabine-based therapy are also eligible * Patients who have completed previous adjuvant therapy without progression, then subsequently have a radiological best response of disease progression on 1st line gemcitabine for metastatic disease are eligible * No hENT1 expression in primary or metastatic tumor sample, confirmed with IHC by a core pathology laboratory prior to study entry also eligible * Performance Status (ECOG) 0 or 1 * Age >=18 years * Palliative radiotherapy (if administered) >=2 weeks prior to CO-1.01 * Adequate hematological and biological function, with no residual gemcitabine-related toxicity * Written consent on an Institutional Review Board (IRB)-approved IC Form prior to any study-specific evaluation Exclusion Criteria: * Patients who have had stable disease, partial response or complete response to first line gemcitabine-based therapy * First-line chemotherapy regimen that does not contain gemcitabine * First-line treatment discontinued due to intolerable gemcitabine-induced toxicity * Second or subsequent line therapy for advanced disease. Prior exposure to CO-1.01 or prior randomization in a protocol studying CO-1.01 (e.g.,Protocol CO-101-001) * Tumor that cannot be evaluated for hENT1 expression or that has hENT1 staining in >50% of cells * Symptomatic brain metastases * Concomitant treatment with prohibited medications (e.g., concurrent anticancer therapy including other chemotherapy, radiation, hormonal treatment [except corticosteroids and megestrol acetate], or immunotherapy) <=14 days prior to CO-1.01 * Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures are not allowed <14 days prior to CO-1.01 administration; stenting procedures are permissible at any time prior to dosing; in all cases, the patient must be sufficiently recovered and stable * History of allergy to gemcitabine or eggs * Females who are pregnant or breastfeeding * Refusal to use adequate contraception for fertile patients (females and males during the study and for 6 months after the last dose of CO-1.01) * Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, psychiatric disturbance, uncontrolled intercurrent illness including active infection, arterial thrombosis, or symptomatic pulmonary embolism) * Any other reason for which the investigator considers the patient should not participate in the study

Study Objectives To investigate the effect of intercostal blockade with and without adjuvants. Conditions: Postoperative Pain, Lung Cancer, Video Assisted Thoracoscopic Surgery, Thoracoscopic Surgery, Nerve Block, Local Anesthesia Intervention / Treatment: DRUG: Dexamethasone, DRUG: Bupivacain Location: Denmark Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: ° Consecutive adult patients over 18 years of age scheduled to undergo VATS because of verified/suspected lung cancer. Exclusion Criteria: * Inability to understand verbal and written information. * Preexisting chronic pain condition. * Preoperative daily treatment with pain medication (Non-opioids, opioids, gabapentin/pregabalin). * Previous thoracic surgery. * Previous chemotherapy due to thoracic malignancy and / or radiation therapy. to the thorax. * Pregnant women. * Autoimmune neuromuscular diseases (sclerosis, peripheral neuromuscular disorders). General muscle weakness or atrophy. * Hypersensitivity, allergy or intolerance to dexamethasone, bupivacaine or adrenaline. * Preoperative epidural anaesthesia.

Study Objectives This single arm, multicenter, open-label, Phase II study will enroll chemotherapy-naive participants with metastatic, histologically-confirmed adenocarcinoma of the prostate (stage M1 D2). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Non-surgically castrated participants must continue the use of luteinizing hormone-releasing hormone (LHRH) agonists during protocol treatment. Conditions: Adenocarcinoma of the Prostate Intervention / Treatment: DRUG: IMC-A12 (Cixutumumab) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria * The participant is male and at least 18 years of age * The participant has histologically-confirmed adenocarcinoma of the prostate * The participant has radiographic evidence of metastatic prostate cancer (stage M1 [D2]) * The participant has prostate cancer unresponsive or refractory to hormone therapy * The participant must have evidence of progressive disease defined as at least one of the following: * a. Progressive measurable disease: using conventional solid tumor criteria. * b. Bone scan progression: at least one new lesion on bone scan. * c. Increasing prostate specific antigen (PSA): at least two consecutive rising PSA values over a reference value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2 * The participant has a PSA >= 2 nanograms/milliliter (ng/mL) * The participant has not received prior chemotherapy for metastatic prostate cancer * The participant had prior surgical or medical castration with a serum testosterone level of < 50 ng/mL. If the method of castration is LHRH agonists, the participant must be willing to continue the use of LHRH agonists during protocol treatment * All clinically significant toxic effects (excluding alopecia) of prior surgery, radiotherapy, or hormonal therapy have resolved to grade <= 1 based on National Cancer Institute - Common Terminology Criteria for Adverse Events, (NCI-CTCAE)Version 3.0 * The participant has not received antiandrogen therapy for at least 6 weeks (4 weeks for flutamide) prior to study entry and is without evidence of an antiandrogen withdrawal response. For participants whose progression is documented solely by PSA increase, the most recent PSA value enabling study entry must be drawn after the required antiandrogen washout period * The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 * The participant has adequate organ function including: absolute neutrophil count >= 1500/microliter (μL); platelets >= 100,000/μL; hemoglobin >= 9.0 grams per deciliter (g/dL); bilirubin <= 1.5 times the institutional upper limit of normal (ULN); aspartate transaminase (AST) / alanine transaminase (ALT) <= 3 times ULN (< 5x ULN if liver metastases are present); creatinine <= 1.5 x ULN (or calculated creatinine clearance > 60 milliliter/minute (mL/min); and urine protein <= 1+ (if urine protein is >= 2+, a 24-hour urine collection must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study) * The participant has fasting serum glucose < 120 mg/dL or below the ULN * The participant has adequate coagulation function as defined by an international normalized ratio (INR) <= 1.5 and a partial thromboplastin time (PTT) <= 1.5 ULN (unless on oral anticoagulant therapy). Participants receiving full-dose anticoagulation therapy are eligible provided they meet all other criteria, are on a stable dose of oral anticoagulant or low molecular weight heparin (and if on warfarin have a therapeutic INR between 2 and 3) * The participant is asymptomatic from prostate cancer. Participants with minimal, infrequent cancer-related symptoms are eligible. Criteria regarding pain and analgesic use are detailed below * The participant has a life expectancy > 6 months * The participant, if sexually active, agrees to use contraceptives while on study * The participant has provided signed informed consent Exclusion Criteria * The participant has any active malignancy (other than adequately treated nonmelanomatous skin cancer or other noninvasive or in situ neoplasms), or has an adequately-treated prior cancer but has been disease free for < 3 years * The participant has an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia (well-controlled atrial fibrillation is permitted), psychiatric illness/social situations, active bleeding or pathological condition that carries a high risk of bleeding (eg, tumor involving major vessels, tumor invading to rectal lumen, or known varices), or any other serious uncontrolled medical disorder in the opinion of the investigator * The participant has a known hypersensitivity to therapeutic protein products * The participant has known or suspected brain or leptomeningeal metastases * The participant has received radiotherapy <= 21 days prior to first dose of IMC-A12 * The participant has received prior radiation therapy to > 30% of the bone marrow or prior strontium-89, rhenium-186, rhenium-188, or samarium-153 (participants who have received standard dose radiation to the pelvis for prostate cancer and no additional radiotherapy are eligible) * The participant has a known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness * The participant has received more than one course of radiotherapy to a single site of metastatic bony disease * The participant has a bone scan that indicates "superscan" (that is (ie), extensive metastasis to bone in numerous areas, too numerous to count or define) * The participant is receiving corticosteroids (dexamethasone, prednisone, or others) for anorexia, weight loss, analgesia or other cancer-related symptoms(Corticosteroids may not be instituted once a participant has begun therapy on-study * The participant requires ongoing, regularly scheduled opiate analgesic therapy for cancer related pain. Intermittent, infrequent low-potency opiate-use (example, oxycodone, codeine) is permitted * The participant has a history of prior treatment with other agents that specifically target the insulin-like growth factor (IGF) receptor

Study Objectives This phase I trial studies the side effects of SD-101 when given together with nivolumab and radiation therapy in treating patients with pancreatic cancer that does not respond to treatment with chemotherapy (chemotherapy refractory) and has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as SD-101, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving SD-101, nivolumab, and radiation therapy may work better in treating patients with pancreatic cancer compared to nivolumab or radiation therapy alone. Conditions: Metastatic Pancreatic Adenocarcinoma, Refractory Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8 Intervention / Treatment: BIOLOGICAL: Nivolumab, RADIATION: Radiation Therapy, DRUG: TLR9 Agonist SD-101 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 - 2 * Able and willing to provide written informed consent * Pathology confirmed pancreatic adenocarcinoma by histology or cytology * Life expectancy >= 3 months * Progression during or after greater than or equal to 1 line of systemic treatment for metastatic pancreatic adenocarcinoma. Patients who do not tolerate 1st line systemic treatment for metastatic pancreatic adenocarcinoma are also eligible * >= 1 metastatic liver lesion amenable for radiation, intratumoral injection, and core biopsy * Lesion for radiation, intratumoral injection, and biopsy may not be a previously irradiated lesion but may have been previously treated with liver directed therapy (e.g., radiofrequency ablation [RFA], transarterial chemoembolization [TACE], selective internal radiation therapy [SIRT], etc.) provided there is radiographic evidence of disease progression in the interim since last local/regional treatment * >= 1 target lesion outside the field of radiation, measurable by RECIST v1.1 * Absolute neutrophil count (ANC) >= 1000 cells/mm^3 * Platelet count >= 50,000/mm^3 * Hemoglobin >= 8 g/dL * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 5 times upper limit of normal (ULN) * Alkaline phosphatase =< 5 times ULN * Total bilirubin =< 2 times ULN * Creatinine =< 2 times ULN * Patients with hepatitis B virus are allowed if antiviral therapy has been given for > 8 weeks with viral loads < 100 IU/mL prior to the first dose of trial therapy. Subjects with hepatitis C virus are allowed. Viral loads for hepatitis B and C will be monitored every 4 weeks for patients with active hepatitis B and/or C * Women with childbearing potential and males must be willing to use adequate birth control on trial and until 5 months for women or 7 months for men after the last of study therapy * Ability to adhere to study schedule and protocol requirements * Willing to undergo pre-treatment biopsy and on-treatment biopsy Exclusion Criteria: * Actively receiving cancer directed, systemic therapy * Prior systemic treatment for pancreatic adenocarcinoma within 2 weeks of first study treatment * Known active auto-immune disease or immunodeficiency requiring systemic steroid equivalent to prednisone >= 10 mg/day or immunosuppressive therapy within 14 days or 5 half-lives prior to first dose of trial therapy * History of non-infectious pneumonitis or interstitial lung disease * Active infection requiring systemic therapy defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment * Pregnant or lactating women * Live attenuated vaccine received =< 30 days before first dose of trial therapy * Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Contraindications to radiotherapy including but not limited to radiation sensitivity syndromes e.g., xeroderma pigmentosum, ataxia telangiectasia * Any significant medical condition including additional active malignancies, laboratory abnormalities, or psychiatric illness that would prevent the subject from participating and adhering to study related procedures in the view of the principal investigator

Study Objectives This study will evaluate whether patients who are intolerant and discontinue anastrozole due to grade 2-3 arthralgia-myalgia have a decrease in rheumatological symptoms while taking letrozole Conditions: Breast Cancer Intervention / Treatment: DRUG: letrozole Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Postmenopausal women with HR+ early stage breast cancer at the time of initial diagnosis. For study purposes, postmenopausal is defined as: * Age >= 50 y and amenorrheic for 12 or more months. * Age >= 50 y and amenorrheic for 3 or more months after receiving adjuvant chemotherapy. * Age < 50 y and amenorrheic for 12 or more months. * Prior bilateral oophorectomy. * Prior hysterectomy and has postmenopausal levels of FSH, LH, and estradiol as per local institutional standards. * Age > 55 y and prior hysterectomy. * Patients who are intolerant and discontinue anastrozole 2-3 weeks prior to study entry when given as adjuvant treatment for HR+ early stage breast cancer due to grade 2-3 (NCI-CTCAE V3) arthralgia-myalgia. * Hormone receptor-positive tumors as defined by institutional standards. * ECOG performance status of 0, 1, or 2 * Consent to participate in the trial. - Exclusion Criteria: * Postmenopausal women with HR+ metastatic or locally relapsed breast cancer excluding chest wall recurrence with no evidence of systemic disease. * Recent history of pain associated with non-traumatic bone fracture. * Pain requiring chronic use of analgesics (due to any reason). * History of rheumatological disease except osteoarthritis. * Prior hormonal therapy with AIs other than anastrozole. * Systemic hormone replacement therapy (HRT) less than 4 weeks before study entry other than Estring®, Vagifem® or low dose estrogen vaginal cream. * Concomitant disease which significantly affects quality of life. * Patient unable to complete self administered questionnaire. * Patients unable to sign consent form. Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives This is a standard of care document, outlining the therapy for children with high risk neuroblastoma who are not eligible for Children's Oncology Group (COG) studies. Conditions: Neuroblastoma Intervention / Treatment: DRUG: Carboplatin, BIOLOGICAL: Autologous stem cell infusion, BIOLOGICAL: Granulocyte colony stimulating factor, RADIATION: Radiation therapy, DRUG: Isotretinoin (13-cis-retinoic acid), DRUG: Melphalan, DRUG: Etoposide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Less than 30 years of age at diagnosis of neuroblastoma * No evidence of disease progression: defined as increase in tumor size of >25% or new lesions * Recovery from last induction course of chemotherapy (absolute neutrophil count > 500 and platelet > 20,000) * No uncontrolled infection * Minimum frozen peripheral blood stem cells (PBSCs) of 2 x 10^6 CD34 cells/kg for transplant are mandatory and 2 x 10^6 CD34 cells/kg for back-up are strongly recommended (thus, PBSC of 4 x 106 CD34 cells/kg is encouraged) * Adequate organ function defined as: * Hepatic: aspartate aminotransferase (AST) < 3 x upper limit of institutional normal 8 Cardiac: shortening fraction >= 27% or ejection fraction >= 50%, no clinical congestive heart failure 8 Renal: Creatinine clearance or glomerular filtration rate (GFR) > 60 mL/min/1.73m^2 If a creatinine clearance is performed at end induction and the result is < 100 ml/min/1.73m^2, a GFR must then be performed using a nuclear blood sampling method or iothalamate clearance method. Camera method is NOT allowed as measure of GFR prior to or during Consolidation therapy for patients with GFR or creatinine clearance of < 100 ml/min/1.73m^2 Exclusion Criteria * Patients with progressive disease should consider participating in phase I studies since consolidation therapy using the regimen outlined in this document have not been determined to be useful. * Patients who are delayed in consolidation chemotherapy beyond 8 weeks, and don't meet organ function criteria.

Study Objectives The purpose of this research study is to: * see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery * see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene * see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene * see if the pattern of protein expression in the blood is related to the tumor's sensitivity or resistance to gefitinib treatment. * see if expression of certain genes in the tumor are related to the tumor's sensitivity or resistance to gefitinib treatment. Conditions: Lung Cancer, Non-small Cell Lung Cancer, Bronchioloalveolar Cancer Intervention / Treatment: DRUG: Gefitinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Pathologic confirmation of malignancy at Memorial Sloan-Kettering * Patients must have previously untreated stage I or II NSCLC (T11-2N0M0, T1-2N1M0, T3N0M0) and 1 of the following features: never smoker or < 15 pack year smoking history and/or bronchioloalveolar cancer (either pure BAC, BAC with focal invasion or adenocarcinoma with BAC features) * Patients must have been determined to be operable and resectable by the treating thoracic surgeon. * Age >18 years. * Measurable indicator lesions * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Pregnant or lactating women or women of childbearing potential not using effective contraception. Men participating in the trial must also use effective contraception when sexually active. * Patients may not be receiving any other investigational agents. * Any history of or evidence of interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).

Study Objectives The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold Azacitidine. Conditions: Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia Intervention / Treatment: DRUG: Luitpold Azacitidine, DRUG: Vidaza® Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: DOUBLE

Inclusion Criteria: * Signed informed consent obtained prior to initiation of any study-specific procedures. * Patients with one of the following - myelodysplastic syndrome of the following French-American- British (FAB) subtypes: refractory anemia (RA), RA with ringed sideroblasts (if accompanied by neutropenia, or thrombocytopenia, or requiring transfusion), RA with excess of blasts (RAEB), RAEB in transformation (RAEB-T), or chronic myelomonocytic leukemia (CMMoL); myelofibrosis; chronic myeloid leukemia; or chronic lymphocytic leukemia who's physician feels should receive azacitidine. * Male or female patients aged at least 18 years. * ECOG Performance Status 0-2. * Life expectancy > or = to 3 months. * Adequate organ function, including the following: Hepatic - Total bilirubin < or = to 1.5 x the upper limit of normal (ULN), aspartate transaminases (AST) and alanine transaminases (ALT) < or = to 2 x ULN and Renal - Serum creatinine < or = to 1.5 x ULN. * Female patients of child-bearing potential must have a negative pregnancy test and must be using at least one form of contraception as approved by the Investigator for 4 weeks prior to the study and 4 months after the last dose of azacitidine. * Male patients must use a form of barrier contraception approved by the investigator during the study and for 4 months after the last dose of azacitidine. Exclusion Criteria: * Hypersensitivity to azacitidine or mannitol. * Anticipated need for RBC or platelet transfusion 2 days prior to or up to 2 days after treatment initiation. * Chemotherapy (excluding previous azacitidine treatment) or radiotherapy within 4 weeks of randomization (6 weeks for nitrosoureas or mitomycin C). * Significant electrophysical abnormalities in pre-trial EKG. * Present history of locally advanced or metastatic malignant disease or leukemia. * Use of recreational drugs or history of drug addiction, within the prior 6 months. * Known history of a positive hepatitis screen, including hepatitis B surface antigens or HCV antibodies. * Known history of HIV or syphilis. * History of clinically significant adverse events due to chemotherapy, radiotherapy or investigational agents. * Presence of an advanced malignant hepatic tumor. * Presence of an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders. * Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patients compliance. * Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry. * Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.

Study Objectives The study objective is to evaluate the therapeutic activity, safety and tolerability of axitinib in patients with advanced/metastatic soft tissue sarcoma who are unsuitable for or have relapsed after standard chemotherapy. The therapeutic activity will be separately assessed in angiosarcoma, synovial sarcoma, leiomyosarcomas and other sarcomas. Conditions: Soft Tissue Sarcoma Intervention / Treatment: DRUG: Axitinib Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Pathologically confirmed soft tissue sarcoma, including: * Angiosarcoma, including intermediate and malignant vascular tumours (WHO classification, 2002) and Kaposi's sarcoma. * Leiomyosarcoma, including uterine, skin or non organ origin. * Synovial sarcoma. * Other eligible subtypes of soft tissue sarcoma of Trojani intermediate or high grade, including fibroblastic, fibrohistiocytic, adipocytic, rhabdomyosarcoma, malignant peripheral nerve sheath, and not otherwise specified. See exclusion criteria for ineligible subtypes. * Locally advanced or metastatic disease incurable by surgery or radiotherapy. * Measurable disease according to RECIST criteria. * Evidence of objective disease progression in the past 6 months, without anticancer treatment since progression. * Patients ineligible for chemotherapy (eg. through age, clinical condition or patient refusal) or who have received no more than two prior chemotherapy regimens. * Age >or = 16. * WHO performance status 0, 1 or 2. * At least 4 weeks from prior anticancer treatment (surgery, radiotherapy and systemic therapies) and full recovery from all their adverse effects. * No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be < or = 140 mm Hg, and the baseline diastolic blood pressure readings must be < or = 90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible. * Adequate physiological function: * renal : calculated or measured creatinine clearance > or = 50 ml/min using the Cockcroft-Gault formula (see appendix 5). * haematological: Absolute Neutrophil Count (ANC) > or = 1.5 x 109/L, platelets > or = 100 x 109/L, International Normalized Ratio (INR) < or = 1.2. * hepatic: bilirubin within normal range, AST and ALT < or = 3 x upper limit of normal. * cardiac: Left Ventricular Ejection Fraction (LVEF) measured by Echocardiogram or Multi Gated Acquisition Scan (MUGA) within normal range. * Urinary protein <2+ by urine dipstick. If dipstick is >2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2 g per 24 hours. * Negative pregnancy test and agrees to comply with contraceptive measures * Able to swallow oral medication. Exclusion Criteria: * Ineligible pathological subtypes including: * Osteosarcoma * Ewings/Primitive Neuroectodermal Tumour (PNET sarcomas) * Chondrosarcoma * Gastrointestinal stromal tumours (GIST) * Dermatofibrosarcoma protuberans (DFSP) * Malignant mesothelioma * Mixed mesodermal tumours of uterus * Known central nervous system metastases. * Age < 16. * Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (i.e., carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, primidone, rifabutin, rifampicin, and St. John"s Wort). * Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (i.e., grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, voriconazole, erythromycin, clarithromycin, ergot derivatives, indinavir, saquinavir, ritonavir, nelfinavir and lopinavir). * Previous malignancies (except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or breast) within the past 3 years. * Heart failure > or = New York Heart Association (NYHA) class II. * History within the previous 6 months of any blood clots in the sputum or streaky haemoptysis that was persistent (> 2 weeks) or recurrent (> 3 episodes). * Patients with cavitating lung metastases or any metastasis abutting or invading a major pulmonary blood vessel on baseline CT or MRI scan. * History of bleeding diathesis or coagulopathy within 12 months of study entry * Any of the following within the 12 months prior to trial drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, deep vein thrombosis or pulmonary embolism. * Therapeutic dose warfarin. Low molecular weight heparin is permitted. * Regular treatment with antiplatelet medication, including aspirin >325 mg/day or NSAIDs * History of malabsorption or major gastrointestinal tract resection likely to affect trial drug absorption. * Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use two effective contraception measures during the period of therapy which should be continued for 4 weeks after the last dose of trial therapy. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy which should be continued for 4 weeks after the last dose of trial therapy . The definition of effective contraception will be based on the judgment of the Investigator or designee.

Study Objectives The Acute Pain Service (APS) at Sunnybrook has been using Gabapentin 200 mg three times a day (TID) resulting in anecdotal benefits in terms of analgesia and opioid sparing effects. Higher doses of Gabapentin were associated with an increased incidence of sedation. The purpose of the study is to investigate if Gabapentin 200 mg given three times a day for 72 hours (9doses) results in a reduction in the total amount of opioid required after radical prostatectomy surgery as compared to placebo, and if analgesia is improved. This study will also examine the possible anxiety sparing effects and any health related quality of life (HRQL) changes, which may be a result of our perioperative use of gabapentin. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Gabapentin, DRUG: Placebo Sugar Pill Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Undergoing radical prostatectomy * Able to read and write english (assistance is allowed) * Normal creatinine blood serum level * No known allergies to study medications Exclusion Criteria: * Patients not providing informed consent * Patients less than 18 years of age or greater than 75 years of age * Known allergy to any of the medications being used * History of drug or alcohol abuse * Preoperative pain * Patients unable or unwilling to use PCA * Patients with impaired renal function (Creatinine >106)

Study Objectives The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer. Conditions: Prostate Cancer Metastatic Intervention / Treatment: BIOLOGICAL: PROSTVAC-V, BIOLOGICAL: PROSTVAC-F, DRUG: GM-CSF, OTHER: GM-CSF Placebo, BIOLOGICAL: Placebo Location: Israel, Estonia, Canada, Germany, Russian Federation, Netherlands, Spain, United Kingdom, Denmark, United States, Belgium, Australia, Puerto Rico, Iceland, France, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: Men, >=18years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. Documented progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression). * Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer. OR * PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria). Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated). Exclusion Criteria: Cancer-related pain requiring scheduled opioid narcotics for control (as needed, <= 2x per week is allowed). Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo. Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F. History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin. Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months) Confirmed positive for HIV, hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled. History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis.

Study Objectives To characterize the phenotype in patients with Morton's neuroma and to explore the effect of local administration of Xylocaine (lidocaine) Conditions: Morton's Neuroma Intervention / Treatment: DRUG: Xylocaine, DRUG: Xylocaine, DRUG: Placebo Location: Sweden Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: BASIC_SCIENCE Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: TRIPLE

Inclusion Criteria: * Patients with a clinical diagnosis of Morton's neuroma with symptoms of at least 3 months duration in one foot (affected foot) * Visual analogue scale (VAS) pain-score of = 40 mm in the painful foot at daily activities during the previous week (visit 1) Exclusion Criteria: * Allergy to lidocaine * Scars or other dermal conditions on the feet that may interfere with study procedures

Study Objectives The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Polyphenon E (EGCG) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: BASIC_SCIENCE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * recent biopsy positive for prostate cancer * scheduled for prostatectomy * must be able to swallow capsules * Palpable mass by digital rectal examination (DRE) * Ability to give informed consent and willingness to adhere to study protocol * Age >= 18 years and less than 75 Exclusion Criteria: * abnormal liver function * Prior hormonal or surgical therapy for prostate cancer * Liver or kidney problems that would interfere with metabolism of study drug * Any condition that would hamper informed consent or ability to comply with study protocol * Participation in another research study in the last three months * Known malignancy at any site other than prostate * Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)

Study Objectives In a retrospective study, the investigators will compare patients with locally advanced rectal cancer with high risk factors for failure who were treated with standard therapy or with total neoadjuvant therapy. Conditions: Rectal Cancer Intervention / Treatment: DRUG: Capecitabine Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * histologically proven locally advanced rectal cancer and * the presence of one of the factors: T4, N2, positive mesorectal fascia, presence of extramural vascular invasion or presence of lateral lymph node. Exclusion Criteria: * distant metastases, * concomitant malignancy, * inflammatory bowel disease, or * malabsorption syndrome.

Study Objectives Primary Objective: -To determine the dose and schedule combination of 5-Azacitidine, when used as maintenance treatment after allogeneic transplantation for high-risk AML / MDS. Secondary Objective: -To assess the effect of treatment on survival after allogeneic transplantation for high-risk AML / MDS. Conditions: Myelodysplastic Syndrome, Leukemia Intervention / Treatment: DRUG: Azacitidine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with a diagnosis of AML (WHO classification: >=20% blasts in the bone marrow and / or peripheral blood), or MDS (IPSS intermediate-2 or higher) that at the time of allogeneic transplantation were in. * Induction Failure, relapsed disease or second or greater remission. * Patients in first complete remission that required more than 2 cycles of treatment to achieve the remission. * Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or * HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch) * Age 18 to 75 years and * Left ventricular ejection fraction >40% and * FEV1, FVC and DLCO >40% and * Serum creatinine <1.6 mg/dL and * Serum bilirubin < 1.6 mg/dL and * SGPT < 3 X upper limit of normal and * All patients and donors or guardian should be able to understand and sign informed consent. * Women of childbearing potential (any female who has experienced menarche, and who has not undergone surgical sterilization or is not post-menopausal) must have a negative serum pregnancy test. Exclusion Criteria: * HIV positive * AML or MDS in first complete remission (defined as: bone marrow with less than 6% blasts, no circulating blasts, and a platelet count greater than 100,000 /mm^3.) * Active uncontrolled infection * Pregnancy or breastfeeding

Study Objectives In cancer, the incidence of venous thromboembolism (VTE) is particularly high in patients with myeloma, especially when it is de novo and treated with thalidomide, lenalidomide or erythropoietin. Curiously, the prevention of VTE with LMWH (low-molecular-weight heparin) in myeloma seems no more effective than that achieved with aspirin, while the effectiveness of the latter in the primary prevention of VTE has never been demonstrated regardless of the type of population considered. Meanwhile, a biological study showed that prophylactic doses of LMWH in patients with different types of cancer did not always optimal reduction of thrombin peak during the 24 hours following the injection of LMWH. These clinical and biological studies lead to the conclusion that patients with myeloma may be resistant to the usual doses of preventive LMWH, which may explain the failure of prevention. Initially we intend to investigate whether this resistance to prophylactic doses of LMWH is present in patient's biology and if this resistance is specific to myeloma in hematological cancers. For this, we propose to study the evolution of thrombin generation by Thrombinography during 24 hours after subcutaneous injection of 4500 anti-Xa IU Tinzaparin in 6 patients with de novo myeloma whit high thrombo embolic risk ie treated with thalidomide, lenalidomide or erythropoietin. LMWH is Tinzaparin chosen because it does not accumulate in patients with impaired renal function, and has a greater anti-biological activity thrombotic than other LMWH. To assess whether the observed pattern of thrombin generation is particularly multiple myeloma, we will take the same study in 6 patients with aggressive lymphoma and 6 medical patients hospitalized for acute heart and respiratory failure. Conditions: Lymphoma, Multiple Myeloma Intervention / Treatment: DRUG: Tinzaparin, OTHER: Blood sample Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: BASIC_SCIENCE Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Body weight between 40 and 100 kg * Patient: 2a- With multiple myeloma indication with de novo standard treatment thalidomide or lenalidomide or erythropoietin (group 1) 2b- Or hospitalized for aggressive lymphoma treated with chemotherapy (group 2) 2c- Or older than 40 years and hospitalized at least three days for an acute medical pathology type of acute respiratory or cardiac (group 3) decompensation Exclusion Criteria: * Patient requiring anticoagulant therapy at curative doses * Patients with a lower platelet count 80 G / L * Subject with a history of heparin-induced thrombocytopenia * Subject with a history of hemorrhagic disease * History of severe trauma within 6 weeks prior to enrollment * Organic lesion at risk of bleeding * Poor renal with creatinine clearance <30 ml / min * Hypersensitivity to Tinzaparin * Events or bleeding tendencies associated with coagulation disorders * Subject on oral anticoagulant * For group 3: Presence of hematological malignancy or active cancer

Study Objectives RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells. PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer. Conditions: Prostate Adenocarcinoma, Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage III Prostate Cancer, Stage IV Prostate Cancer Intervention / Treatment: DRUG: Bicalutamide, DRUG: Flutamide, DRUG: Goserelin Acetate, DRUG: Ipilimumab, DRUG: Leuprolide Acetate, OTHER: Pharmacological Study Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * NOTE: All values must be obtained =< 14 prior to study entry * Histologically confirmed adenocarcinoma of the prostate staged within 180 days of study enrollment, >cT2cN0/M0 stage with or without metastatic disease, with the exclusion of central nervous system (CNS) metastases; includes post radical prostatectomy patients with a rising PSA * An initial PSA >= 4.0 ng/mL (Hybritech Assay) * For those patients who have received hormone therapy =< 21 days, a documented PSA of >= 4.0 prior to initiation of hormone therapy is acceptable. * For patients who are post radical prostatectomy, a rising PSA is acceptable. * Adequate organ function defined as: WBC >= 3,000/uL; platelets >= 75,000/uL; total bilirubin =< 1.5 mg/dL; transaminases =< 2.5 x upper limit of normal (ULN); serum creatine =< 2.0 mg/dL or calculated creatinine clearance >= 60 mL/min * ECOG performance status of 0-2 * Able to understand and sign informed consent Exclusion Criteria: * Underlying other serious medical condition which, in the opinion of the investigator precludes study participation; this includes immune-suppressive disease such as AIDS or autoimmune disorders such as multiple sclerosis, lupus, or myasthenia gravis * Patients not recovered from major infections and/or surgical procedures * Prior hormonal therapy > 21 days prior to enrollment, including estrogens, LH/RH agonists, or antiandrogens * Recent (=< 3 months of informed consent) usage of immune-suppressive medication including steroids, Immuran, Cyclosporin; topical or inhalational steroid use is permissible * Prior systemic chemotherapy * Prior radiation therapy to the prostate * Prior malignancy, unless the patient has been cancer-free for five years or more * Uncontrolled underlying medical or psychiatric illness, or serious active infections * Patient unwilling to complete all required follow-up visits * History of motor neuropathy considered of the autoimmune origin (e.g. Guillian-Barre Syndrome) * Concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer * For patients who elect to undergo the baseline transrectal needle biopsy of the prostate, current usage of systemic anticoagulation therapy, i.e. heparin or Coumadin or inability to discontinue aspirin, aspirin-containing products or ibuprofen for seven days prior to the prostate biopsies required for this study * No other investigational drugs will be allowed during the study * Other chemotherapy, radiation therapy, immunotherapy, hormonal therapy, or biologic therapy may not be used while the patient is on study

Study Objectives To evaluate the safety and tolerability of AMG 256 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D). Conditions: Advanced Solid Tumors Intervention / Treatment: DRUG: AMG 256 Location: United States, Belgium, Australia, Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Age >= 18 years at the time of signing informed consent. * Life expectancy of > 3 months, in the opinion of the investigator. * Participant must have histologically or cytologically proven metastatic or locally advanced solid tumors not amenable to curative treatment with surgery or radiation for which: * No standard therapy exists, or * Standard therapy has failed, not available, or * In the investigator's opinion, standard therapy does not result in meaningful clinical benefit. * At least 1 measurable lesion >= 10 mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study. Exclusion Criteria: * Primary brain tumor, untreated or symptomatic brain metastases and leptomeningeal disease. * History of other malignancy within the past 2 years, with the following Exceptions: * Malignancy treated with curative intent and with no known active disease present for >= 2 years before enrollment and felt to be at low risk for recurrence by the treating physician. * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. * Adequately treated cervical carcinoma in situ without evidence of disease. * Adequately treated breast ductal carcinoma in situ without evidence of disease. * Prostatic intraepithelial neoplasia without evidence of prostate cancer. * Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ. * History of solid organ transplantation. * Major surgery within 28 days of study day 1. * Live vaccine therapy within 4 weeks prior to study day 1. * Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. * Active infection requiring oral or intravenous therapy. * Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or cardiac arrhythmia requiring medication. * History of severe allergic reactions or severe acute hypersensitivity reaction. * Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 3 months after the last dose of AMG 256. * Female participants of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 3 months after the last dose of AMG 256. * Female participants of childbearing potential with a positive pregnancy test assessed within 48 hours prior to day 1 of treatment by a serum pregnancy test. * Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 5 months after the last dose of AMG 256. * Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 5 months after the last dose of AMG 256. * Male participants unwilling to abstain from donating sperm during treatment and for an additional 5 months after the last dose of AMG 256. * Participant has known sensitivity to any of the products or components to be administered during dosing. * Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge. * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participants safety or interfere with the study evaluation, procedures or completion.

Study Objectives This study is intended for Chronic Lymphocytic Leukemia patients who have already undergone a first or second treatment with drugs named bendamustine and rituximab. It will observe the results of this treatment and evaluate its efficacy and side effects. Conditions: Chronic Lymphocytic Leukemia Intervention / Treatment: DRUG: Bendamustine + Rituximab Location: Italy Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Diagnosis of CLL / Small Lymphocytic Lymphoma (CLL/) according to the World Health Organisation (WHO) classification 2008. * Patients who were treated with first and second-line Bendamustine plus Rituximab (BR) from January 2008 to December 2014 from European centres adhering to the GIMEMA group and the ERIC group. * Previously untreated CLL patients requiring therapy according to the NCI criteria (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of BR as first-line treatment. * CLL patients that received one previous line of treatment using alkylating agents and/or purine analogues with or without monoclonal antibodies, requiring second-line therapy according to the NCI criteria (Hallek M et al, Blood 2008 - Appendix G) and treated with at least one cycle of bendamustine and rituximab. * Age >= 18 years old. * Signed written informed consent according to ICH/EU/GCP and national local law. Exclusion Criteria: * Patients who have received 2 or more lines of prior therapy. * Patients with: Transformation of CLL into aggressive lymphomas (Richter's Syndrome). HIV infection. Active and uncontrolled HCV and/or HBV infections or liver cirrhosis.

Study Objectives OBJECTIVES: Primary Objectives 1.To evaluate the safety and feasibility of the sequential use of a DNA methyltransferase (DNMT) inhibitor (decitabine) with a targeted biological agent against EGFR (panitumumab) for KRAS wild type tumors in the second or third line treatment of advanced metastatic colorectal cancer. Secondary Objectives 1. To examine re-expression or a reduction in promoter methylation in genes involved in tumor suppressor pathways known to be important in colorectal cancer (CRC) or involved in EGFR signaling pathway. 2. Evaluate overall response (OR = CR +PR) according to RECIST criteria at 2, 4, and 6 cycles. Progression free survival, measured as the first evidence of tumor growth from the start of treatment will also be assessed. 3. Measure CEA levels at the beginning of each cycle to examine if they correlate with treatment response or disease progression. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: Dacogen™ (decitabine), DRUG: Vectibix® (panitumumab) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * At least third line stage IV metastatic colorectal cancer or metastatic colorectal cancer patients intolerant to second line therapy. * Tumor is KRAS wild-type. * ECOG performance status of 0-1 * Age (>=)18 * Adequate bone marrow function (ANC >1500/mm3, hemoglobin >9 g/dL (which may be obtained by transfusions or growth factor support), platelets >100,000) * Adequate hepatic function (AST and ALT <2.5x upper limit of normal (ULN), unless there are liver metastasis in which case AST and ALT <5.0 x ULN. * Adequate renal function (Serum creatinine <=1.5 x ULN or calculated creatinine of >50 ml/min) * Timing of the last previous chemotherapy, radiotherapy, immunotherapy, and/or surgery treatment to be greater than 2 weeks before protocol entry * Patients are required to have recovered from side effects of prior treatment with the exception of neuropathy (to be determined by treating physician and NCI CTCAE grade <1) * Women of child-bearing age must be willing to use adequate contraception and have negative serum or urine pregnancy test within 3 days prior to registration. * Available archived tumor sample or provide consent for re-biopsy of tumor. * Able to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelines. * Patients must have at least one measurable site of disease according to RECIST criteria Exclusion Criteria: * Prior treatment with decitabine. * Known hypersensitivity to decitabine and panitumumab or their excipients. * Any of the following within 6 months prior to drug administration: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, or cerebrovascular accident. * Ongoing cardiac dysrhythmias of NCI CTCAE grade >=2 that are independent of previous treatments. * Severely impaired lung function by medical history and/or clinical lung exam. * Any active (acute or chronic) or uncontrolled infection/ disorders. * Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy * Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis * Hypertension that can not be controlled by medications (>170/100 mmHg) * Diagnosis of any secondary malignancy within the last 3 years (except basal cell carcinoma, squamous cell skin cancer, or stage I or less carcinoma fully treated) * Known HIV infection by patient disclosure or on active treatment. * Other severe acute or chronic medical or psychiatric condition or lab abnormality that would place the participant at excess risk by participating as judged by the study investigator. * Women of child-bearing age who are pregnant or lactating * History of noncompliance to medical regimens * Patients unwilling to or unable to comply with the protocol

Study Objectives The purpose of the study is to assess the efficacy of the association of Lenalidomide (Revlimid) and R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, vincristine and Prednisone) in a population of patients with follicular lymphoma as measured by the response rate at the end of treatment. Conditions: Follicular Lymphoma Intervention / Treatment: DRUG: Lenalidomide and R-CHOP Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with follicular lymphoma, (WHO) grade 1, 2 or 3a with at least one of the following signs requiring initiation of treatment: * Bulky disease according to the GELF criteria: nodal or extra-nodal mass >7cm in its greater diameter * B symptoms * Elevated serum (LDH) or beta 2-microglobulin * Involvement of at least 3 nodal sites (each >3cm) * Symptomatic spleen enlargement * Compressive syndrome * Pleural or peritoneal effusion * Aged from 18 to 70 years * WHO performance status 0, 1 or 2 * Signed inform consent * Life expectancy of >= 90 days (3 months). * Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL not more than 3 days from the start of study drug and must either commit to continued abstinence from heterosexual intercourse (and confirmed on a monthly basis) or begin one effective method of birth control, at least four weeks before she starts taking lenalidomide, and maintain that method throughout the entire duration of study drug therapy (including dose interruptions), and for four weeks after the end of study treatment with lenalidomide, even if she has amenorrhea. FCBP must also agree to pregnancy testing at least every three weeks and must be counseled at a minimum of every three weeks about pregnancy precautions and risks of fetal exposure. * Men must agree not to father a child and agree to use a condom throughout study drug therapy, during any dose interruption, and for one week after cessation of study drug therapy, if their partner is pregnant or of child bearing potential. Men must also agree not to donate semen during study drug therapy and for one week after end of study drug therapy. Men must be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure. * All subjects must abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy. * Agree not to share study drug with another person and to return all unused study drug to the investigator. * A female patient is considered to have childbearing potential unless she meets at least one of the following criteria 1) Age >= 50 years and naturally amenorrhoeic for >= 1 year (amenorrhoea following cancer therapy does not rule out childbearing potential); or 2) Premature ovarian failure confirmed by a specialist gynaecologist or 3) Previous bilateral salpingo-oophorectomy (BSO), or hysterectomy, or 4) XY genotype, turner syndrome, uterine agenesis. Exclusion Criteria: * Previous treatment with immunotherapy or chemotherapy: * Chlorambucil or Cyclophosphamide per os alone during less than 6 months, if stopped more than one year before inclusion * Rituximab alone during less than three months, if stopped more than one year before inclusion * Previous radiotherapy except if localized to one lymph node area * Other type of lymphomas: Burkitt, T cell, lymphocytic, CD 20 negative * Central nervous system or meningeal involvement * Contraindication to any drug contained in the chemotherapy regimen * (HIV) disease, active hepatitis B or C * Any serious active disease or co-morbid medical condition (according to investigator's decision) * Any of the following laboratory abnormalities. * Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L). * Platelet count < 100,000/mm3 (100 x 109/L). * Serum (SGOT/AST) or (SGPT/ALT) 5.0 x upper limit of normal (ULN). * Serum total bilirubin > 2.0 mg/dL (34 µmol/L), except in case of hemolytic anemia. * Calculated creatinine clearance (Cockcroft-Gault formula) of < 50 mL /min * Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for >= 3 years * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Pregnant or lactating females. * Prior >= Grade 3 allergic reaction/hypersensitivity to thalidomide. * Prior >= Grade 3 rash or any desquamating (blistering) rash while taking thalidomide. * Subjects with >= Grade 2 neuropathy. * Prior use of lenalidomide. * Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy.

Study Objectives This study was designed to determine the efficacy and safety of neoadjuvant docetaxel and epirubicin (DE) with or without human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that a combined angiogenesis inhibiting therapy to chemotherapy could further enhance the cytotoxic activity in breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: docetaxel and epirubicin, DRUG: docetaxel and epirubicin plus endostatin Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis) * Stage ⅡA-ⅢC * Age 18-70 * ECOG performance status 0-2 * No evidence of distant metastasis * No previous therapy * Normal hematologic function * left ventricular ejection fraction greater than 50 percent * No abnormality of renal or liver function * Written informed consent Exclusion Criteria: * With allergic constitution or possible allergic reflection to drugs to be used in this study * Any concurrent uncontrolled medical or psychiatric disorder * History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease. * History of bleeding diathesis * Being pregnant or nursing

Study Objectives The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy. Conditions: Aggressive B Cell Non-Hodgkin Lymphomas at High Risk for R-CHOP-21-induced Neutropenia Intervention / Treatment: DRUG: lipegfilgrastim, DRUG: pegfilgrastim Location: Italy, Spain, Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Signed and dated Independent Ethics Committee (IEC)-approved written informed consent * Age >=65 years and <=85 years * Histological documentation of aggressive B cell NHL * Planned to receive systemic anticancer therapy with at least 6 cycles of R-CHOP-21, according to local standards * ECOG score <=2 * Life expectancy of at least 3 months * Adequate bone marrow, renal and hepatic function within 14 days before start of chemotherapy * The patient is capable of understanding and complying with parameters as outlined in the protocol * Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment and for 30 days after discontinuation of study drug. * The patient, if a man, is surgically sterile, or, if capable of producing offspring, is currently using an approved method of birth control and agrees to continued use of this method for the duration of the treatment (and for 90 days after taking the last dose of study * Other Criteria apply, please contact the investigator for more information Exclusion Criteria: * Participation in a clinical study within 30 days before randomization * Any chemotherapy within the last 3 months before start of chemotherapy. A prephase to reduce tumor burden prior to start of R-CHOP is allowed. * The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.) * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of chemotherapy. * Active cardiac disease * Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of chemotherapy. * Ongoing infection, known history of human immunodeficiency virus (HIV) infection, tuberculosis, or chronic hepatitis B or C. * Patients with evidence or history of bleeding diathesis. * Non-healing wound, ulcer or bone fracture. * Renal failure requiring hemo- or peritoneal dialysis. * Any conditions that may interfere with the patient's participation in the study or evaluation of the study results. * Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation. * Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study. * Treatment with lithium at screening or planned during the study. * Other Criteria apply, please contact the investigator for more information

Study Objectives The purpose of this study is to investigate the control of disease in pretreated patients with advanced non small cell lung cancer (NSCLC) harbouring HER2 exon 20 mutations as well as the safety and tolerability (how severe the side effects are) of the treatment with afatinib. Conditions: NSCLC Intervention / Treatment: DRUG: Afatinib Location: Netherlands, Spain, Switzerland, Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed non small cell lung cancer * Stage IIIB (non amenable to curative-intent multimodal treatment) or IV NSCLC, according to 7th TNM classification. * Contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals); * brain MRI or CT within 28 days before the date of enrolment. * Non-predominant squamous subtype (<50% squamous cells). * Previous treatment with a platinum based chemotherapy for advanced disease; or Disease relapse or progression within <6 months after adjuvant platinum based chemotherapy, or (definitive) platinum-based chemo(radio)therapy for stage I-III NSCLC * Measurable or evaluable disease (according to RECIST 1.1 criteria). Not eligible: patients with only one measurable or evaluable tumour lesion which was resected or irradiated prior to enrolment. * Locally documented HER2 mutation * Age >= 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * Life expectancy >3 months. * Adequate haematological function: * WBC >= 2000/μL * haemoglobin >= 9 g/dL * neutrophils count >=1.5×109/L * platelet count >= 100 × 109/L * Adequate liver function: * Total bilirubin <= 1.5 × ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) * ALT < 2.5 × ULN * AST < 2.5 × ULN * GGT < 2.5 × ULN. * Adequate renal function: Calculated creatinine clearance >= 45mL/min (Cockroft-Gault) * Patient capable of proper therapeutic compliance, and accessible for correct followup. * Women of childbearing potential (< 1 year without menstruation or < 2 years without menstruation following chemotherapy) must have a negative serum or urine pregnancy test within 7 days before beginning trial treatment. * Sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the trial treatment and for a period of at least 28 days following the last administration of trial drug. * Recovered from any previous therapy related toxicity to <=Grade 1 at date of enrolment (except for recovery to <=Grade 2 of alopecia, fatigue, creatinine increased, lack of appetite as well as stable sensory neuropathy) * Written Informed Consent (IC) for trial treatment must be signed and dated by the patient and the investigator prior to any trial-related intervention. * Tumour block available for central review of HER2 mutation status. Exclusion Criteria: * Patient with mixed small-cell and non-small-cell histologic features * Uncontrolled lepto-meningeal metastatic disease. Radiotherapy-treated or asymptomatic brain metastases are allowed (no systematic screening). Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids or have been on stable dose of corticosteroids for at least 4 weeks before starting trial treatment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks before date of enrolment. * Previous treatment with HER2 targeted antibody or tyrosine kinase inhibitor including afatinib. * Major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial. * Patient who has had in the past 3 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast. * History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of III or IV (see Table 2 below), unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to enrolment. * Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient's capacity to participate in the trial. * Known HIV, active Hepatitis B or Hepatitis C infection (screening not required). * Known or suspected hypersensitivity to afatinib or any of its excipients. * Interstitial lung disease or pulmonary fibrosis. * Women who are pregnant or in the period of lactation. * Patients with any concurrent systemic anticancer therapy. * Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption. * Patient who received treatment with an investigational drug agent during the 3 weeks before enrolment in the trial.

Study Objectives P-cadherin may play a part in tumor growth; PF-03732010 is a new drug that inhibits P-cadherin. This study will test how well the drug is tolerated, and what effects there might be. Blood will also be taken to measure the amount of drug in blood. Conditions: Neoplasms Intervention / Treatment: DRUG: PF-03732010 Location: United States, Korea, Republic of, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Advanced solid tumors refractory to (or intolerant of) established therapy known to provide clinical benefit, or for which there is no standard therapy * Age >= 18 years of age * Adequate bone marrow function as defined by: absolute neutrophil count (ANC) >=1500/uL, hemoglobin >= 9 g/dL, platelets > 100,000/uL * Adequate liver function as defined by: bilirubin < 1.5 x ULN, AST, ALT and ALP < 2.5 x ULN, or < 5 x ULN with documented liver and/or bone metastases * Serum creatinine < 1.5 x ULN * ECOG status 0-1 * Availability of biopsy tumor tissue (or fine needle aspirate) for testing of P-cadherin expression * Tumor tissue (or fine needle aspirate) showing over-expression of P-cadherin * Must be able to give written informed consent * Be able to comply with scheduled study visits, treatment plans, laboratory tests and other procedures Exclusion Criteria: * Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of study entry * Patients with carcinomatous meningitis or untreated brain metastases. * History of significant low platelet count, and/or bleeding disorders, requiring medical or surgical intervention * History of significant bleeding episodes within 6 months, unless the source of bleeding has been resected

Study Objectives This Phase II study randomized R-ACVBP and R-CHOP as induction treatment in patients from 18 to 59 with DLBCL CD20+ lymphoma and 2 or 3 adverse prognostic factors of the age-adjusted IPI. The consolidation treatment is allocated according to the response to induction treatment assessed by PET after the 2nd and 4th induction cycles. Conditions: Lymphoma, B-Cell, Lymphoma, Large-Cell, Diffuse Intervention / Treatment: DRUG: R-CHOP14 induction regimen, DRUG: R-ACVBP14 induction regimen Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification). * Age from18 to 59 years, eligible for transplant. * Patient not previously treated. * Baseline FDG-PET Scan (PET0) performed before any treatment with at least one hypermetabolic lesion. * Index prognostic factors (IPI) 2 or 3. * With a minimum life expectancy of 3 months. * Negative HIV, HBV and HCV serologies £ 4 weeks (except after vaccination). * Having previously signed a written informed consent. Exclusion Criteria: * Any other histological type of lymphoma. * Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included. * Central nervous system or meningeal involvement by lymphoma. * Contra-indication to any drug contained in the chemotherapy regimens. * Poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal level) unless these abnormalities are related to the lymphoma. * Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration. * Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ)cervical carcinoma. * Any serious active disease (according to the investigator's decision). * Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy. * Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception * Adult patient under tutelage. * Impossibility to performed a baseline PET scan (PET0) before randomization and treatment beginning

Study Objectives This phase II trial is studying irinotecan to see how well it works in treating children with refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Conditions: Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma, Childhood Grade I Meningioma, Childhood Grade II Meningioma, Childhood Grade III Meningioma, Childhood Infratentorial Ependymoma, Childhood Oligodendroglioma, Childhood Supratentorial Ependymoma, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Visual Pathway and Hypothalamic Glioma, Recurrent Childhood Visual Pathway Glioma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent Osteosarcoma, Unspecified Childhood Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: irinotecan hydrochloride Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed CNS or solid tumors recurrent or refractory to standard therapy * Solid tumors: * Neuroblastoma * Ewing's Sarcoma/peripheral primitive neuroectodermal tumor (PNET) * Osteosarcoma * Rhabdomyosarcoma * Other extracranial solid tumors * CNS tumors: * Medulloblastoma/PNET * Ependymoma * Brain stem glioma * Other CNS tumor * Intrinsic brain stem tumor (biopsy required only if previously treated with radiosurgery) * Classic optic glioma (histologic requirement waived) * Measurable disease by imaging studies * No lesions assessable only by radionuclide scan * Previously irradiated lesions used to evaluate tumor response must show evidence of an interim increase in size * Performance status - Karnofsky 50-100% if more than 10 years old * Performance status - Lansky 50-100% if 10 years or younger * At least 8 weeks * Absolute neutrophil count greater than 1,000/mm^3 * Platelet count greater than 100,000/mm^3 * Hemoglobin greater than 8 mg/dL * Inadequate peripheral blood counts due to bone marrow infiltration allowed * Bilirubin no greater than 1.5 mg/dL * SGPT less than 5 times normal * Creatinine normal * Glomerular filtration rate at least 70 mL/min * No severe uncontrolled infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study * At least 3 weeks since prior immunotherapy and recovered * No concurrent biologic therapy * At least 3 weeks since prior chemotherapy (8 weeks since prior nitrosoureas) and recovered * No more than 2 prior chemotherapy regimens * No other concurrent chemotherapy * Prior topotecan allowed * No prior irinotecan * Concurrent dexamethasone for brain tumor patients allowed if on a stable or decreasing dose for at least 2 weeks prior to study * At least 3 weeks since prior endocrine therapy * No other concurrent endocrine therapy * See Disease Characteristics * At least 8 weeks since prior extended radiotherapy (including evaluable lesions) and recovered * No prior total body radiotherapy * No concurrent radiotherapy * See Disease Characteristics * At least 3 weeks since prior investigational agents * No other concurrent investigational agents * No concurrent anticonvulsants * No concurrent medications that would interfere with the P-450 enzyme system function (e.g., erythromycin, cimetidine, fluconazole)

Study Objectives The purpose of this study is to evaluate the safety and efficacy of niraparib in participants with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 3 or 4 previous chemotherapy regimens. Conditions: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer Intervention / Treatment: DRUG: Niraparib Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria * Japanese female participants aged >= 20 years on the day of signing informed consent. * Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. * Participants must agree to undergo tumor homologous recombination deficiency/deficient (HRD) testing, and this test result must show that participants have an HRD-positive tumor (defined by the presence of a deleterious or suspected deleterious breast cancer gene (BRCA) mutation or be positive for genomic instability) by the central laboratory selected by the sponsor. Note 1: The study HRD test result must be received prior to enrollment. The tumor sample may be submitted for HRD testing prior to the screening period (ie, within 40 days before Cycle 1 Day 1) if the consent has been obtained and it appears the participant is likely to meet other eligibility requirements. Note 2: If historic blood germline BRCA mutation (gBRCAmut) is detected by a prior gBRCAmut testing, then tumor HRD sample test results are not required prior to enrollment; however, HRD testing still needs to be performed. * Participants must have histologically diagnosed, relapsed, high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and have not experienced disease progression at least 6 months to the last chemotherapy containing platinum-based anticancer agents. * Participants must have completed 3 or 4 previous chemotherapy regimens. Participants must have completed their last chemotherapy regimen >4 weeks prior to treatment initiation. * Participants must have at least one measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1). * Participants must have performance status of <=1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale. * Participants must have adequate organ function as indicated by the following laboratory values: * Absolute neutrophil count (ANC) >=1,500/μL. * Platelet count >=150,000/μL. * Hemoglobin >=10 g/dL. * Serum creatinine <=1.5× institutional upper limit of normal (ULN) OR calculated creatinine clearance >=50 mL/minute, using the Cockcroft-Gault equation. * Total bilirubin <=1.5×ULN OR direct bilirubin <=1×ULN. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5×ULN unless liver metastases were present, in which case they had to be <=5×ULN. * Participants must have formalin-fixed, paraffin-embedded tumor samples available from the primary or recurrent cancer or agree to undergo fresh biopsy prior to study treatment initiation. * Participants must be able to take oral medications. * Female participants of childbearing potential must be negative for pregnancy test (beta-human chorionic gonadotropin [β-hCG]) within 7 days prior to receiving the first dose of study treatment. * Female participants who: * Are postmenopausal for at least 1 year before the screening visit, OR * Are surgically sterile, OR * If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 180 days after the last dose of study drug, OR * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], condoms only, withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) Exclusion Criteria * Participants who have had palliative radiotherapy encompassing >20% of the bone marrow within 1 week of the first dose of study treatment. * Participants who have any known, persistent (>4 weeks), Grade >=3 hematologic toxicity from last cancer therapy. * Participants who have any known, persistent (>4 weeks), Grade >=3 fatigue during the last cancer therapy. * Participants who have received pelvic radiotherapy as treatment for primary or recurrent disease within 1 year of the first dose of study treatment. * Participants who have symptomatic, uncontrolled brain or leptomeningeal metastases. To be considered "controlled," central nervous system (CNS) disease must have undergone treatment (eg, radiation or chemotherapy) at least 1 month prior to study enrollment. The participant must not have had any new or progressive signs or symptoms related to the CNS disease and must have been taking a stable dose of steroids or no steroids (as long as these were started at least 4 weeks prior to enrollment] or no steroids). A scan to confirm the absence of brain metastases at baseline was not required. Participants with spinal cord compression might have been considered if they had received definitive treatment for this and evidence of clinically stable disease for 28 days. * Participants who have known hypersensitivity to the components of niraparib. * Participants who have had prior treatment with a known poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors. * Participant who have had treatment with any investigational products within 28 days or 5 half-lives (whichever was longer) before the first dose. * Participants who have had major surgery per Investigator judgment within 3 weeks of the first dose. Participant must have recovered from any effects of any major surgery. * Participants who have diagnosis, detection, or treatment of invasive second primary malignancy other than ovarian cancer <=24 months prior to study enrollment (except basal or squamous cell carcinoma of the skin that was definitively treated). Note: Participants must not have any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), irrespective of the time for disease history. * Participants who are considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days of the first dose) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, small bowel obstruction or other serious gastrointestinal disorder, or any psychiatric disorder that prohibits obtaining informed consent. * Participants who have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment. * Participants who have received a live virus or bacterial vaccines within 4 weeks of the first dose of study treatment. * Participants who have a history or current evidence of any condition, therapy, or lab abnormality (including active or uncontrolled myelosuppression [ie, anemia, leukopenia, neutropenia, thrombocytopenia]) that might confound the results of the study, interfere with the participant's participation throughout the study period, or study participation is not in the best interest of the participant. * Participants who are regular user (including "recreational use") of any illicit drugs at the time of signing informed consent or have a recent history (within the past year) of drug or alcohol abuse. * Participants who are pregnant or breast-feeding or expecting to conceive within the planned duration of the study. NOTE: If a breast-feeding woman discontinue breast-feeding, she may be enrolled in the study. * Participants who are immunocompromised (participants with splenectomy are allowed). * Participants who have known human immunodeficiency virus (HIV) positive. * Participants who have known hepatitis B surface antigen (HBsAg) positive, or known or suspected active hepatitis C virus (HCV) infection. NOTE: Participants who are positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B virus (HBV) viral load. Participants who have positive hepatitis C virus antibody (HCVAb) must have an undetectable HCV viral load.

Study Objectives To evaluate tolerance, toxicity, and preliminary evidence of antitumor efficacy of intralesionally administered tumor necrosis factor (TNF) and to define a maximum tolerated dose (MTD) for single intralesional injections. In addition, to assess the effects of TNF injections on Kaposi's sarcoma (KS) lesions as measured by P-32 magnetic resonance spectroscopy. Conditions: Sarcoma, Kaposi, HIV Infections Intervention / Treatment: DRUG: Tumor Necrosis Factor Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT

Inclusion Criteria Patients must have: * Biopsy-proven Kaposi's sarcoma (KS) with multiple cutaneous lesions. * Minimum life expectancy of 3 months. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Clinically significant cardiac disease. * Known hemorrhagic diathesis or active bleeding disorder. * Clinically apparent vascular disease. * Known lipoprotein disorders. * History of seizure disorder or central nervous system (CNS) metastasis. * Additional malignancy. Concurrent Medication: Excluded: * Cardiac agents. * Anticoagulants. * Thrombolytic agents. * Nonsteroidal anti-inflammatory drugs. * Corticosteroids. * Aspirin. * Vasodilators. Patients with the following are excluded: * Additional malignancies or other conditions listed in Patient Exclusion Co-Existing Conditions. Prior Treatment: Excluded within 4 weeks of study entry: * Chemotherapy. * Radiotherapy. * Immunotherapy.

Study Objectives The purpose of this study is to establish the safety of rituximab plus cyclophosphamide, doxorubicin, vincristine,prednisone (R-CHOP) in HIV-infected and HIV-uninfected diffuse large B-cell lymphoma (DLBCL) patients in Malawi. Conditions: Diffuse Large B-cell Lymphoma, HIV Intervention / Treatment: DRUG: R-CHOP Location: Malawi Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Informed consent obtained and signed. Age 18-60 years. ECOG performance status (PS) 0-2. Histologically confirmed CD20-positive DLBCL, any stage, bulky or nonbulky disease. * No prior treatment for lymphoma. Willing to have documentation of HIV status. CD4 count >= 100 cells/µL if HIV-infected. Measurable disease by physical exam. * Adequate bone marrow renal and hepatic function as evidenced by the following: * Absolute neutrophil count (ANC) >= 1,000/µL * Platelet count >= 100,000/µL * Creatinine <= 1.5 mg/dL * Total bilirubin <= 2 mg/dL (unless directly attributable to lymphoma) * Able to understand and comply with protocol requirements for the entire length of the study. * Willing to reside <50 kilometers from Kamuzu Central Hospital (KCH) until chemotherapy completion. * Negative urine B-HCG in women of child-bearing potential within 7 days prior to start of treatment. * Fertile patients must use effective contraception (condom or other barrier methods, oral contraceptives, implantable contraceptives, intrauterine devices) during and for six months after completion of treatment. Exclusion Criteria * Pregnant or nursing. Central nervous system (CNS) involvement by lymphoma (clinically or cytologically confirmed). * Receiving other anti-cancer or investigational therapy during study treatment, apart from those agents specified in the study protocol. * Known cardiac disease including any of the following: * New York Heart Association (NYHA) Grade II or greater congestive heart failure * History of myocardial infarction or unstable angina within 6 months prior to Day 1 * History of stroke or transient ischemic attack within 6 months prior to Day 1 * Second active malignancy requiring systemic therapy. * Hepatitis B virus (HBV) surface-antigen positive unless receiving both tenofovir and lamivudine as part of antiretroviral therapy if HIV-infected. * Other serious, ongoing, non-malignant disease or infection that would in the opinion of the site investigator compromise other protocol objectives.

Study Objectives The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer Conditions: Breast Cancer Intervention / Treatment: DRUG: Gemcitabine, DRUG: cisplatin Location: Russian Federation, Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * You are female in the age of 18 to 75 years old. * You have been diagnosed with the metastatic breast cancer. * You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up. * You must sign this informed consent form Exclusion Criteria: * You are pregnant or breastfeeding. * Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study. * You have been diagnosed with serious concomitant or acute infectious disease. * You have used experimental medications within the last month.

Study Objectives RATIONALE: Pemetrexed may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with oxaliplatin may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed given together with oxaliplatin in treating patients with metastatic solid tumors or lymphoma. Conditions: Lymphoma, Solid Tumor Intervention / Treatment: DRUG: oxaliplatin, DRUG: pemetrexed disodium Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Pathologic or cytologic diagnosis of solid tumors or lymphoma * Metastatic disease * No curative or effective therapy exists * Measurable or nonmeasurable disease * No clinically relevant third-space fluid collections * Fluid collections must be drained before study enrollment * No leukemia * No CNS metastases Exclusion Criteria: * ECOG performance status 0-2 * Life expectancy >= 12 weeks * ANC >= 1,500/mm^3 * Platelet count >= 100,000/mm^3 * Hemoglobin >= 9 g/dL * Bilirubin <= 1.5 times upper limit of normal (ULN) * AST and ALT <= 3.0 times ULN (5 times ULN if liver has tumor involvement) * Creatinine clearance >= 45 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study therapy * No active infection or other serious illness that would preclude study participation * No weight loss >= 10% within the past 6 weeks * No peripheral neuropathy (e.g., diabetic neuropathy) >= CTC grade 1 * Must be able to take concurrent vitamin B12 and folic acid PRIOR CONCURRENT THERAPY: * No more than 1 prior chemotherapy regimen for metastatic disease * More than 12 months since prior adjuvant therapy * More than 30 days since prior drug that has not received regulatory approval * More than 30 days since prior radiation therapy and recovered (alopecia allowed) * Prior standard postoperative adjuvant radiation therapy for rectal cancer allowed * No prior radiation therapy to >= 25% of bone marrow * No prior oxaliplatin or pemetrexed disodium * No NSAIDs or acetylsalicylic acid 2 days before (5 days for long-acting agents [e.g., piroxicam]), during, and for 2 days after each dose of pemetrexed disodium * No concurrent nonpalliative radiation therapy or surgery for cancer * No concurrent hormonal cancer therapy (except medroxyprogesterone) * No other concurrent experimental medications (except thymidine) * No other concurrent chemotherapy or immunotherapy * No other concurrent anticancer therapy * Concurrent palliative radiation therapy allowed for small areas of painful metastasis that cannot be managed adequately by systemic or local analgesics

Study Objectives Biliary tract cancer is relatively rare cancer, with generally poor prognosis. In metastatic/recurrent biliary tract cancer, the most commonly used 1st-line chemotherapy is gemcitabine+cisplatin combination. However, there is no standard 2nd-line chemotherapy and there is no validated targeted therapeutic agent, even though this tumor harbors diverse genetic characteristics. TH-302 (1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-bromoethyl) diamidophos-phate is a nitroimidazole-linked prodrug of a brominated version of isophosphoramide mustard (Br-IPM). When exposed to hypoxic conditions, TH-302 is reduced at the nitroimadazole site of the prodrug by intracellular reductases leading to the release of Br-IPM. Br-IPM can then act as a DNA crosslinking agent. In areas of normoxia, TH-302 remains intact as a prodrug and toxicity is minimized. In addition, preclinical data suggest that after activation, the active moiety may diffuse to areas outside the hypoxic region, demonstrating a "bystander" effect and possibly exhibiting additional anti-tumor activity. It is well known that biliary tract cancer is hypovascular tumor, so it contains large hypoxic area in the tumor. Therefore it would be worthy to test TH-302 in biliary tract cancer. This study is a phase II study of TH-302 monotherapy as second-line treatment in advanced biliary tract cancer, to investigate efficacy and safety of TH-302 monotherapy. Conditions: Biliary Tract Cancer Intervention / Treatment: DRUG: TH-302 monotherapy Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically / cytologically verified, non-resectable, recurrent, or metastatic biliary tract carcinoma including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder carcinoma. * Patients who were previously treated with one palliative chemotherapy (patients who recurred within 6 months after completion or during adjuvant chemotherapy are allowed) * Patients must have measurable or evaluable disease by RECIST 1.1 * ECOG PS: 0, 1 * Age >= 20 years * Adequate bone marrow function defined as: Hb >= 8 g/dl, ANC >= 1500/mcL, Platelets >= 100K/mcL * Adequate renal function defined as serum creatinine < 1.6 mg/dl and/or measured creatinine clearance from 24-hour urine collection of >= 60 ml/min * Adequate hepatic function defined as total bilirubin <= 2 mg/dl, ALT/AST <= 5 x ULN. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Evidence of another active cancer that may influence patient outcome, except for nonmelanoma skin carcinoma, melanoma in-situ, in-situ carcinoma of the cervix curatively treated, treated superficial bladder cancer, and adenocarcinoma of the prostate that has been surgically treated with a post-treatment PSA that is non-detectable. * Known brain metastases or primary central nervous system tumors with seizures that are not well controlled with standard medical therapy. * Uncontrolled intercurrent illness including, but not limited to psychiatric illness/social situations that would limit compliance with study requirements. * Known HIV positive patient * Significant cardiovascular disease including congestive heart failure (New York Heart Association Class II or higher) or active angina pectoris. * History of a myocardial infarction within 6 months. * History of a stroke or transient ischemic attack within 6 months. * Clinically significant peripheral vascular disease. * Major surgical procedure within 4 weeks. * Uncontrolled infection. * Pregnant (positive pregnancy test) * Breast-feeding should be discontinued if a nursing mother is to be treated on clinical trial. * History of any organ or bone marrow transplant. * Subjects who are taking medications that prolong QT interval and have a risk of Torsades de Pointes. * Subjects taking a medication that is a moderate or strong inhibitor or inducer of CYP3A4.

Study Objectives This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Conditions: Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia Intervention / Treatment: RADIATION: 3-Dimensional Conformal Radiation Therapy, DRUG: Cyclophosphamide, DRUG: Cytarabine, DRUG: Dexamethasone, DRUG: Doxorubicin Hydrochloride, DRUG: Leucovorin Calcium, DRUG: Mercaptopurine, DRUG: Methotrexate, DRUG: Pegaspargase, DRUG: Thioguanine, DRUG: Vincristine Sulfate Location: Canada, New Zealand, Switzerland, United States, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients must be enrolled on AALL03B1 prior to enrollment on AALL0331 * Initial white blood cells (WBC) < 50,000/ul * Newly diagnosed B-precursor acute lymphoblastic leukemia * Standard-risk (SR) disease meeting 1 of the following criteria: * SR-average by age and WBC * No unfavorable features * Rapid early responder (RER) by day 15 * CNS 1 or 2 * Minimal residual disease (MRD) negative on day 29 * Trisomies of 4, 10, and 17 or TEL-AML1 translocation and RER and CNS2 allowed * SR-low by age and WBC * No unfavorable features * RER by day 15 * MRD negative on day 29 * CNS1 * Favorable cytogenetics-trisomies of 4, 10, and 17 or TEL-AML translocation * SR-high * Unfavorable features meeting >= 1 of the following criteria: * MLL rearrangements and RER * Steroid pretreatment * CNS3 * Slow early responder by morphology or MRD * Patients with Down syndrome are allowed * Patients with overt testicular disease are not eligible for this study, but may be eligible for AALL0232 * Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the central nervous system [CNS] status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment * Patients receiving prior steroid therapy may be eligible for AALL0331 study * Patients with a contraindication to additional asparaginase therapy, following Induction, are not eligible for the Standard Risk-Low study, and should be removed from protocol therapy at the end of Induction * Patients who are assigned to the standard risk-average group following Induction and who meet the HRQOL * Age at diagnosis >= 2 years (note that this is a more restrictive age range than for the therapeutic component of the study) * At least one parent with reading comprehension of English or Spanish languages for which validated surveys exist * Diagnosis at one of the institutions participating in this limited institution correlative study * A parent or legal guardian must sign a written informed consent/parental permission for all patients * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Study Objectives Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent and/or metastatic adenoid cystic cancer or other salivary gland cancers. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Conditions: High-grade Salivary Gland Carcinoma, High-grade Salivary Gland Mucoepidermoid Carcinoma, Low-grade Salivary Gland Carcinoma, Low-grade Salivary Gland Mucoepidermoid Carcinoma, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Salivary Gland Cancer, Salivary Gland Acinic Cell Tumor, Salivary Gland Adenocarcinoma, Salivary Gland Adenoid Cystic Carcinoma, Salivary Gland Malignant Mixed Cell Type Tumor Intervention / Treatment: DRUG: lapatinib ditosylate, OTHER: laboratory biomarker analysis Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologically documented or cytologically confirmed adenoid cystic, or other malignant salivary gland carcinomas of major or minor salivary gland origin; all patients must have either EGFR and/or erbB2 expressing tumors (for definitions of EGFR and erbB2 expression to be enrolled in this study; EGFR and erbB2 expression will be determined using archival paraffin samples for all study patients where possible; if these samples are unavailable then patients must undergo a biopsy to determine their EGFR and erbB2 status * Patients must have recurrent and/or metastatic disease that is progressive and not amenable to surgery or curative radiotherapy; progressive disease is defined as one of the following occurring within 6 months of study entry: * At least a 20% increase in radiologically or clinically measurable disease * Appearance of any new lesions or * Deterioration in clinical status * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan * Patients may have had unlimited prior therapy; however, there must be at least a 4 weeks' interval between any chemotherapy (6 weeks for nitrosoureas or mitomycin C), radiotherapy or surgery and study enrollment; exceptions may be made however, for low dose, non-myelosuppressive radiotherapy - please contact the Principal Investigator (Dr. L. Siu) PRIOR to registration if questions arise about the interpretation of this criterion; for patients who received local therapy prior to study entry, there must be either progression of measurable disease documented within the treatment field, or must have measurable disease outside the treatment field prior to study entry * Life expectancy of greater than 12 weeks * ECOG performance status 0,1, or 2 * Leukocytes >= 3,000/uL * Absolute neutrophil count >= 1,5000/uL * Platelets >= 100,000/uL * Total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) =< 2.5 x institutional upper limit of normal * Creatinine within normal institutional limits OR * Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal * Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan: Note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution * Must be willing and able to undergo tumor biopsy once before and once during investigational therapy; patients must have tumor lesions accessible for biopsy for correlative studies; the decision regarding the safety of doing a biopsy will be made by an interventional radiologist rather than the investigator and must be documented in writing; in cases where there is a medical contraindication to tumor biopsy, exception may be granted only upon discussion with the principal investigator * Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016 will be determined following review of their use by the principal investigator; a list of medications and substances known or with the potential to interact with CYP450 isoenzymes is provided in: Cytochrome P-450 Enzymes and Drug metabolism; in: Lacy CF, Armstrong LL, Goldman MP, Lance LL eds; Drug Information Handbook 8TH ed. Hudson, OH; LexiComp Inc. 2000: 1364-1371 * HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with GW572016; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated * Patients requiring oral anticoagulants (coumadin, warfarin) are eligible provided there is increased vigilance with respect to monitoring INR; if medically appropriate and treatment available, the investigator may also consider switching these patients to LMW heparin, where an interaction with GW572016 is not expected * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign a written informed consent document * Able to swallow and retain oral medication; alternately, for patients who require feeding via nasogastric tubes or who cannot swallow whole tablets, study entry is allowed by following instructions on drug administration Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or * Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Patients who have had prior treatment with EGFR or erbB2 targeting therapies * Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy * Patients with known brain metastases but have remained stable for at least 3 months since completion of radiotherapy or surgery, have no significant neurological deficits, and are off corticosteroids, may be allowed on study; patients with symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * Patients with a history of other active malignancy in the past 5 years (with the exception of adequately treated cervical carcinoma in situ and non-melanomatous skin cancers) are excluded * History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016 * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because GW572016 is member of the 4-anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects; breastfeeding should be discontinued if the mother is treated with GW572016 * HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study * Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis) * Concomitant requirement for medication classified as CYP3A4 inducer or inhibitor

Study Objectives This is a study of a regimen of melphalan and autologous stem cells for patients with multiple myeloma. We hypothesize that this particular regimen will improve the survival of these patients. Conditions: Multiple Myeloma Intervention / Treatment: PROCEDURE: Stem Cell Transplant, DRUG: Cyclophosphamide + Mesna, DRUG: Melphalan, BIOLOGICAL: Granulocyte-colony stimulating factor Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following: * After initial therapy in either first complete or partial remission or no objective response * After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response * Is not eligible or has refused any protocols of higher priority * 18 - 75 years of age * Adequate organ function defined as: * Hematologic: hemoglobin >= 8 gm/dl (untransfused), white blood cells (WBC) >= 3000/μl, absolute neutrophil count (ANC) >= 1500/μl, platelets >= 100,000/μl (untransfused) * Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA scan * Hepatic: bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal * Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) >50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) > 50% predicted * Performance status: Karnofsky performance of > 80%. * Free of active uncontrolled infection at the time of study entry. * At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas. * Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee. Exclusion Criteria: * Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens. * Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.

Study Objectives RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with erlotinib works in treating patients with metastatic or recurrent pancreatic cancer. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Erlotinib, DRUG: gemcitabine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed locally advanced, metastatic or recurrent pancreatic carcinoma * Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension * No prior chemotherapy for metastatic or recurrent disease is allowed. Prior adjuvant chemotherapy is allowed provided that patients did not receive gemcitabine and the chemotherapy was completed > six months prior to initiation of study therapy. Prior erlotinib therapy is not allowed * Available tumor specimen that was obtained at the time of diagnosis and/or prior to study entry is highly encouraged * Age >= 18 years * Life expectancy greater than 3 months * Zubrod performance status <= 2 * Patients must have normal organ and marrow function as defined below: * leukocytes >= 3,000/μL * absolute neutrophil count >= 1,500/ μL * platelets >= 100,000/ μL * total bilirubin <= 1.5 X institutional upper limit of normal * AST(SGOT)/ALT(SGPT) <= 3 X institutional upper limit of normal, unless the liver is involved with tumor, in which case the AST/ALT must be <= 5 X institutional upper limit of normal * creatinine clearance >= 50 mL/min/1.73 m2, as measured by 24hour collection OR * creatinine <= 1.5 X institutional upper limit of normal * The effects of erlotinib and gemcitabine on the developing human fetus at the recommended therapeutic doses are unknown. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients may not be receiving any other investigational agents. * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib or gemcitabine. * Secondary primary malignancy. Concurrent or history of another malignancy < 5 years. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because erlotinib and gemcitabine have the potential for teratogenic or abortifacient effects. Breastfeeding should be discontinued if the mother is treated with study drugs. * Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy.

Study Objectives The aim of this double-blinded prospective randomised trial is to explore the potential benefits of early postoperative administration of Synbiotics (combination of prebiotics and probiotics) to patients who have undergone colectomy for cancer. The patients are randomised to either synbiotics or placebo administration at the day they are able to tolerate po liquid diet and for 15 days thereafter. Primary end points of the study will be: Assessment of gastrointestinal function-related quality of life at 1, 3 and 6 months postoperatively by the use of the validated questionnaire GIQLI (Gastrointestinal Quality of Life Index) Secondary end points will be: -Assessment of functional bowel disorders (diarrhea, constipation, etc) at 1, 3 and 6 months postoperatively based on the respective domains of the validated instrument EORTC QLQ-C30 Conditions: Colorectal Neoplasms Intervention / Treatment: DIETARY_SUPPLEMENT: Synbiotics, DIETARY_SUPPLEMENT: Placebo Location: Greece Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: QUADRUPLE

Inclusion Criteria: * Colectomy for histologically proven colorectal adenocarcinoma Exclusion Criteria: * Pregnancy, * hereditary cancer, * history of inflammatory bowel disease, * metastatic disease at presentation, * emergency operation, * major postoperative complications

Study Objectives Evaluation of the efficacy of inositol treatment in women with PCOS in relation to the phenotype (according to the Rotterdam Criteria) Conditions: Polycystic Ovary Syndrome Intervention / Treatment: DIETARY_SUPPLEMENT: Myo-inositol Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * women with PCOS of any phenotype Exclusion Criteria: * hormonal treatment (such as contraceptive pill) * use of supplements containing myo-inositol * severe co-morbidities

Study Objectives This randomized phase II trial studies how well atezolizumab with or without cobimetinib works in treating patients with bile duct cancer that has spread to other places in the body (metastatic) and cannot be removed by surgery (unresectable) or gallbladder cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cobimetinib is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving atezolizumab with cobimetinib may work better at treating patients with bile duct and gallbladder cancer. Conditions: Gallbladder Carcinoma, Metastatic Cholangiocarcinoma, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Unresectable Cholangiocarcinoma Intervention / Treatment: DRUG: Atezolizumab, PROCEDURE: Biopsy, PROCEDURE: Biospecimen Collection, DRUG: Cobimetinib, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Pathologically confirmed metastatic or unresectable cholangiocarcinoma or gallbladder carcinoma (GBC), having received at least 1 prior line of systemic therapy, and received no more than 2 prior lines of therapy in the metastatic setting (disease recurrence =< 6 months from the last dose of adjuvant therapy in resected patients will be considered the first line of therapy) * Includes intrahepatic cholangiocarcinoma (IHC), extrahepatic cholangiocarcinoma (EHC), and gallbladder carcinoma (GBC), but not ampulla of vater cancers * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral CT scan, MRI, or calipers by clinical exam; assessment must be completed within 4 weeks of randomization * Age >= 18 years. Because no dosing or adverse event data are currently available on the use of cobimetinib in combination with atezolizumab in patients < 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%) * Life expectancy of greater than 2 months * Leukocytes >= 2,500/mcL (within 2 weeks of randomization) * Absolute neutrophil count >= 1,500/mcL (within 2 weeks of randomization) * Platelets >= 75,000/mcL (within 2 weeks of randomization) * Hemoglobin >= 8 g/dL (within 2 weeks of randomization) * Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled) (within 2 weeks of randomization) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x ULN (within 2 weeks of randomization) * Creatinine clearance >= 30 mL/min/1.73 m^2 by Cockcroft-Gault OR creatinine < 1.5 x ULN (within 2 weeks of randomization) * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose) (within 2 weeks of randomization) * Administration of atezolizumab and cobimetinib may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; women of childbearing potential must agree to use either two adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy, or to abstain from heterosexual activity (complete abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of study agent; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; male patients must agree to use an adequate method of contraception, or to abstain from heterosexual activity (complete abstinence), prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of study agent * Ability to understand and the willingness to sign a written informed consent document * Patients positive for human immunodeficiency virus (HIV) are allowed on study, but HIV-positive patients must have: * A stable regimen of highly active anti-retroviral therapy (HAART) * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections * A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard polymerase chain reaction (PCR)-based tests * Oxygen saturation >= 92% on room air Exclusion Criteria: * Received chemotherapy or radiotherapy within 3 weeks prior to randomization or those who have not recovered to =< grade 1 adverse events (other than alopecia) due to agents administered more than 3 weeks earlier; herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to randomization; for patients who received prior immunotherapy (eg anti-CTLA-4), at least five drug half-lives must have passed before the patient may enroll on this study; however, the following therapies are allowed: * Hormone-replacement therapy or oral contraceptives * Palliative radiotherapy for bone metastases >= 2 weeks prior to randomization * Prior treatment with a MEK inhibitor or ERK inhibitor * Prior treatment with any anti-PD-1 or anti-PD-L1 antibody, prior allogeneic bone marrow transplantation, or prior solid organ transplantation * Treatment with any investigational agent within 4 weeks prior to cycle 1, day 1, or five drug half-lives (whichever is longer) * Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 6 weeks prior to cycle 1 day 1; * Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled * The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed * Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases, with the following exceptions: * Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following: * Radiographic demonstration of clinical stability upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study * No stereotactic radiation or whole-brain radiation within 28 days prior to randomization * Screening CNS radiographic study >= 4 weeks from completion of radiotherapy and >= 2 weeks from discontinuation of corticosteroids * Has a known concurrent malignancy that is expected to require active treatment within two years, or may interfere with the interpretation of the efficacy and safety outcomes of this study in the opinion of the treating investigator; superficial bladder cancer, non-melanoma skin cancers, or low grade prostate cancer not requiring therapy should not exclude participation in this trial * Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * Allergy or hypersensitivity to components of the cobimetinib formulations * History of congenital long QT syndrome or corrected QT interval (QTc) > 450 msec within 2 weeks of randomization * Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower, as determined by echocardiogram or multi-gated acquisition (MUGA) scan within 4 weeks of randomization * Patients who meet any of the following exclusion criteria related to ocular disease will be excluded from study entry: * Known risk factors for ocular toxicity, consisting of any of the following: * History of serous retinopathy * History of retinal vein occlusion (RVO) * Evidence of ongoing serous retinopathy or RVO at screening * Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 enzymes are ineligible; these include St. John's wort or hyperforin (potent CYP3A4 enzyme inducer) and grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor); such substances can significantly increase or decrease the serum level of cobimetinib; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease * Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA) * History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible * Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible * Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: * Rash must cover less than 10% of body surface area (BSA) * Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%) * No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids) * History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted * Severe infections within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia * Signs or symptoms of infection within 2 weeks prior to randomization * Received oral or intravenous (IV) antibiotics within 2 weeks prior to randomization; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible * Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study * Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab * Influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active tuberculosis (TB), symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Symptomatic CHF is defined as New York Heart Association (NYHA) CHF class II or higher disease * Pregnant women are excluded from this study because both atezolizumab and cobimetinib are expected to cause fetal harm if used during pregnancy; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cobimetinib or atezolizumab, breastfeeding should be discontinued if the mother is treated with either therapy; these potential risks may also apply to other agents used in this study * Inability or unwillingness to swallow pills * History of malabsorption syndrome or other condition that would interfere with enteral absorption * Clinically significant ascites, defined as ascites that is symptomatic or has resulted in a paracentesis in the past 3 months

Study Objectives The study was designed to investigate the optimal management of hyperglycemia developed during pasireotide treatment in participants with Cushing's disease or Acromegaly, which was not manageable with metformin. This was a Phase IV, multi-center, randomized, open-label study. Eligible patients started pasireotide subcutaneously (s.c.) for Cushing's disease and pasireotide LAR (long-acting release) for Acromegaly. Participants being treated with pasireotide s.c or LAR at screening were eligible as long as they met protocol criteria during the screening period. If previously normo-glycemic participants experienced an increase in their fasting blood glucose and met the criteria for diabetes while on pasireotide, they started anti-diabetic treatment using metformin. If they continued to have elevated blood glucose above target on metformin within the first 16 weeks, they were randomized in a 1:1 ratio to receive treatment with incretin based therapy or insulin for approximately 16 weeks. Participants who continued to receive clinical benefit after completing the Core Phase could enter an optional Extension Phase if pasireotide was not commercially available in their country or a local access program was not available to provide drug. Patients continued in the Extension Phase until the last participant randomized in the Core Phase completed 16 weeks of treatment post-randomization. Conditions: Cushing's Disease, Acromegaly Intervention / Treatment: DRUG: Pasireotide s.c., DRUG: Sitagliptin, DRUG: Liraglutide, DRUG: Insulin, DRUG: Pasireotide LAR, DRUG: Metformin Location: India, Germany, Thailand, Turkey, Peru, Brazil, Denmark, United States, Belgium, China, Russian Federation, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients greater than or equal to 18 years old * Confirmed diagnosis of Cushing's disease or acromegaly Exclusion Criteria: * Patients who require surgical intervention * Patients receiving DPP-4 inhibitors or GLP-1 receptor agonists within 4 weeks prior to study entry * HbA1c > 10 % at screening * Known hypersensitivity to somatostatin analogues Other protocol-defined inclusion/exclusion criteria may apply.

Study Objectives This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow fibrosis either alone or in combination with ruxolitinib in participants with primary myelofibrosis (PMF) and post polycythemia vera or post essential thrombocythemia myelofibrosis (ET/PV MF). The study is designed as a two-stage trial. In the stage 1, participants will be randomized into two cohorts to receive either 200 or 700 mg of study drug. In the stage 2, participants on ruxolitinib will be randomized to receive either 200 or 700 mg of study drug. Conditions: Myelofibrosis Intervention / Treatment: DRUG: Simtuzumab, DRUG: Ruxolitinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Must be diagnosed with PMF or post ET/PV MF with intermediate-1, intermediate-2 or high risk disease according to the international working group (IWG) prognostic scoring system, or if with low risk disease then with symptomatic splenomegaly that is >= 10 cm below left costal margin by physical exam. * Must have adequate organ function as demonstrated by the following: * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) <= 2.5x upper limit of normal (ULN), or <= 4x ULN (if upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis [EMH] related to MF); * Direct bilirubin <= 1.5 x ULN; or <= 2x ULN (if upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis [EMH] related to MF); * Serum creatinine <= 2.5 mg/dL. * In Stage 2, participants must be on ruxolitinib for at least 8 weeks and on a stable dose for at least 4 weeks. * Eastern cooperative oncology group (ECOG) performance status (PS) <= 2 * Treatment-related toxicities from prior therapies must have resolved to Grade <= 1 * Women of childbearing potential and men must agree to using one medically approved (ie, mechanical or pharmacological) contraceptive measure and have their partners agree to an additional barrier method of contraception for the duration of the study and for 90 days after the last administration of study drug. Definition of female of child bearing potential and a list of acceptable contraceptive methods for this study applies per protocol. Exclusion Criteria: * Any serious medical condition or psychiatric illness that would prevent, (as judged by the treating physician) the participant from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Pregnant or lactating. * Known history of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B. * History or presence of any form of cancer within the 3 years prior to enrollment, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis. * Participation in an investigational drug or device trial within 2 weeks prior to study Day 1 or within 5 times the half-life of the investigational agent in the other clinical study, if known. * Use of any cytotoxic chemotherapeutic agents (eg, hydroxyurea), corticosteroids (prednisone <= 10 mg/day or corticosteroid equivalent is allowed), or immune modulators (eg, thalidomide) within 2 weeks and interferon use within 4 weeks prior to study Day 1. * Symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication. * History of surgery within 2 weeks prior to enrollment or anticipated surgery during the study period. * Any other condition that might reduce the chance of obtaining data required by the protocol or that might compromise the ability to give truly informed consent.

Study Objectives This randomized pilot clinical trial studies dexamethasone in reducing oral pain and dry mouth after surgery in patients with oropharyngeal cancer. Dexamethasone may help lower pain and dry mouth caused by surgery. Conditions: Dysphagia, Pain, Stage I Oropharyngeal Squamous Cell Carcinoma, Stage II Oropharyngeal Squamous Cell Carcinoma, Stage III Oropharyngeal Squamous Cell Carcinoma Intervention / Treatment: DRUG: Dexamethasone, DRUG: Dexamethasone, OTHER: Placebo, PROCEDURE: Quality-of-Life Assessment, OTHER: Questionnaire Administration, PROCEDURE: Transoral Robotic Surgery Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Patients must be diagnosed with oropharyngeal squamous cell carcinoma (SCC) that are surgical candidates * Macroscopic resection of the tumor via TORS must be planned with curative intent * Patient must be willing to remain on corticosteroid therapy for 4 days postoperatively * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients with known distant metastases or other malignancies * Patients with a history of allergy or adverse reaction to corticosteroids * Patients with a history of diabetes * Patients with fasting capillary blood glucose of > 140 on the day of surgery * Patients on chronic corticosteroids * Chronic alcohol abuse (> 6 alcoholic beverages daily) * Patients with a history of severe chronic pain on high dose narcotics (> 25 mg of oxycodone or equivalent daily) preceding diagnosis of cancer * Patients taking significant cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors or inducers, i.e. protease inhibitors (ritonavir, nelfinavir, etc), clarithromycin, ketoconazole, fluconazole, verapamil, diltiazem, carbamazepine, phenytoin, phenobarbital, Rifampin, efavirenz, nevirapine * Patients who have received any investigational medication within 6 weeks of enrollment, or who are scheduled to receive an investigational drug during the course of the study * Patients who will undergo complex head and neck surgery in addition to the TORS procedure requiring reconstruction with a free flap * Patients who have had any previous head and neck surgery that has affected swallowing, voice or speech or who have had previous radiation to the head or neck * Patients who have any confounding medical or neurological conditions that have the potential to affect cognition, speech or swallowing function; i.e. stroke, neurodegenerative disease, neuromuscular movement disorders, head injury, etcetera * Psychiatric illness/social situations that would limit compliance with study requirements * Excluded patients will be allowed to participate in the trial on an observational basis only

Study Objectives The prognosis of patients with newly diagnosed glioblastoma is dismal despite recent therapeutic improvements Using standard therapy with temozolomide (TMZ) and radiotherapy (60 Gy), the median overall survival time (mOS) is 14.6 months (Stupp et al., 2005). Since in a previous non-randomized bicentric phase II trial, primary combination chemotherapy with lomustine (CCNU) and TMZ was highly effective (mOS 23 months; UKT-03 trial; Herrlinger et al., 2006; Glas et al., 2009) the proposed trial further investigates the efficacy of CCNU/TMZ in a randomized multicenter phase III setting against standard therapy. In case the projected phase III trial confirms the phase II data, CCNU/TMZ combination would be significantly better than TMZ monotherapy and would thus be the new standard treatment for newly diagnosed GBM patients with a methylated MGMT promotor. Thus, this trial has the potential to profoundly change the standard therapy of this most aggressive brain tumor. Since in the previous trial only patients with a methylated MGMT (mMGMT) promoter had a benefit from CCNU/TMZ (mOS in the mMGMT group 34 months, in the non-mMGMT group 12.5 months; Glas et al., 2009) while patients with a non-methylated MGMT did not have any benefit, the trial is restricted to mMGMT patients.The CeTeG trial randomizes in a 1:1 fashion newly diagnosed GBM patients (18-70 years) for either standard TMZ therapy (concomitant and 6 courses à 4 weeks of adjuvant TMZ therapy) or experimental CCNU/TMZ therapy (6 courses à 6 weeks). Both arms include standard radiotherapy (RT) of the tumor site (30 x 2 Gy). Assuming that CCNU/TMZ therapy increases the median overall survival (mOS) from 48.9% (standard TMZ) to 70% (CCNU/TMZ; 75% in the previous phase II trial, Glas et al., 2009), 2 x 68 patients have to be accrued. Patients will be accrued over 24 months and each patient will be followed for at least 24 months adding up to a total minimal duration of the time from first patient in until the end of the follow-up time of 48 months. The primary endpoint is overall survival; secondary endpoints include progression-free survival, response rate, acute and late toxicity, and quality of life. Conditions: Glioblastoma Intervention / Treatment: DRUG: Temozolomide and lomustine, DRUG: Temozolomide Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * written informed consent * patients have to be in a cognitive state that allows them to understand the rationale and necessity of study therapy and procedures. * newly diagnosed histologically proven GBM or gliosarcoma WHO Grad IV * methylated MGMT promoter in the tumor * estimated life expectancy of at least 12 weeks * Karnofsky Performance Score (KPS) >= 70% * patient compliance and geographic proximity that allow adequate follow up * male and female patients with reproductive potential must use an approved contraceptive method * pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained prior to treatment start * Adequate organ function as described below: Adequate bone marrow reserve: white blood cell (WBC) count > 3000/µl, granulocyte count >1500/µl, platelets > 100000/µl, haemoglobin >= 10 g/dl Adequate liver function bilirubin < 1.5 times above upper limit of normal range (ULN), ALT and AST < 3 times ULN creatinine < 1.5 times ULN Adequate blood clotting: PT and PTT within normal limits Negative HIV test Exclusion Criteria: * prior malignancy * prior chemotherapy * prior radiotherapy to the brain * concurrent administration of any other anti-tumor therapy * allergy or other intolerability of temozolomide, CCNU, dacarbazine or other nitrosourea derivatives * unable to undergo MRI * past medical history of diseases with poor prognosis * known HIV infection, active Hepatitis B or C infection * any active infection * female patients that are pregnant or breastfeeding * patients with reproductive potential who do not accept to use contraception * treatment in another clinical trial * any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up scheduled visits (at the discretion of investigator)

Study Objectives The major objective of this two-stage phase II study is to determine whether tamoxifen is deserving of further study in metastatic bladder cancer. Tamoxifen is expected to function as a cytostatic (and not cytotoxic) agent, and may produce more disease stability than regression. Sustained stable disease is considered to be clinically important and the more likely event. Hence, 4-month freedom from progression is chosen as the primary end-point instead of response rate. Freedom from progression is defined as the period from start of therapy to the time of objective radiologic progression. A total of 25 subjects will be enrolled, 15 during stage 1 and 10 during stage 2 of a two-stage minimax design phase II study. Pre-therapy evaluation (within 3 weeks of initiation of therapy): * History and physical examination (H and P) * Performance status (PS) assessment * CBC (complete blood counts) * CMP (complete metabolic profile) * Pregnancy test (in women younger than 50) * Computed tomography (CT) scan of the chest, abdomen and pelvis * Bone scan if bone pain or raised alkaline phosphatase * Biopsy (may use previous biopsy specimen) * Samples of plasma from the routine CBC and CMP will be banked indefinitely for future biomarker studies at the Scott Department of Urology. Treatment plan: Therapy will be administered as an outpatient. Tamoxifen is administered at 20 mg/day as a single daily oral dose. Clinical assessment of patients by a history and physical examination will be performed every 4 weeks (one cycle). Objective radiological assessment of response will be made every 8 weeks or earlier if clinically indicated. A CT (computerized tomography) scan of the abdomen, pelvis and chest will be performed at baseline and every 2 cycles. A response is confirmed by repeating the scans in 4 weeks. Bone scan is performed if the patient complains of new bone pain or has raised alkaline phosphatase. A radiologist who is blinded to the treatment regimen reads the scans. The RECIST criteria are used to define response. Tamoxifen is continued until progressive disease or intolerable side effects occur. Conditions: Urinary Bladder Neoplasms Intervention / Treatment: DRUG: Tamoxifen Location: United States, Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients previously diagnosed with bladder cancer who have already received 1-2 systemic therapy regimens (chemotherapy or biological therapy or both) but including at least one chemotherapy regimen. * Patients who have had the cancer spread to other parts of the body. * Patients must have adequate liver function. Exclusion Criteria: * Patients who have uncontrolled nervous system metastasis * Patients who are pregnant * Patients who have had systemic therapies within the past 4 weeks * Patients who plan to have major surgery within 2 weeks * Patients who have Grade III/IV heart problems * Patients who have severe and/or uncontrolled medical disease. * Patients who might be at high risk for deep vein thrombosis

Study Objectives The purpose of this study is to study the effect of a commonly used antibiotic, doxycycline, on the production of ovarian hormones and menstrual cycles in women with Polycystic Ovarian Syndrome (PCOS). Conditions: Polycystic Ovarian Syndrome (PCOS), Irregular Menstrual Cycles, Androgen Excess Intervention / Treatment: DRUG: doxycycline, OTHER: Sugar Pill Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Women between 18 and 40 years of age. * History of PCOS with < 8 periods the proceeding year * Clinical or biochemical evidence of androgen excess * BMI <40 * Willingness to sign consent for study including participation with collection of blood specimens * Willingness to discontinue OCP for duration of study period up to 36 weeks Exclusion Criteria: * Pregnancy * Hypersensitivity to doxycycline or tetracycline * History of Cushing's syndrome * History of hyperprolactinemia * History of congenital adrenal hyperplasia * Significant hepatic impairment, including serum AST or ALT >1.5 times upper limits of normal. * Significant renal impairment, GFR <60 ml/min * Current use of metformin, statins, glucocorticoids, spironolactone and/or anti-estrogens.

Study Objectives This phase I trial studies the side effects and best dose of tivantinib in treating younger patients with solid tumors that have returned after a period of improvement or have not responded to treatment. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Childhood Solid Neoplasm Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, DRUG: Tivantinib Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * PART A: Patients on dose levels -1 or 1 must have a body surface area (BSA) >= 0.65 m^2 at the time of study enrollment; patients on dose levels 2 or 3 must have a BSA >= 0.45 m^2 at the time of study enrollment * PART B: There is no minimum body surface area requirement for patients in part B * Patients with relapsed or refractory solid tumors including central nervous system (CNS) tumors are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG) * Patients must have either measurable or evaluable disease * Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life * Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; note: neurologic deficits in patients with CNS tumors must have been stable or improving for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score * Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy: * Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea) * Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair * Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair * Immunotherapy: At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines * Monoclonal antibodies: At least 3 half-lives of the antibody after the last dose of a monoclonal antibody * Radiation therapy (XRT): At least 14 days after local palliative XRT (small port); at least 150 days must have elapsed if prior total-body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow (BM) radiation * Stem cell infusion without TBI: No evidence of active graft vs. host disease and at least 84 days must have elapsed after transplant or stem cell infusion * Patients may not have received prior therapy with tivantinib * Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 * Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) * Patients with known bone marrow involvement will be eligible for study provided they meet the blood counts above (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 5 of every cohort of 6 patients with a solid tumor must be evaluable for hematologic toxicity for the dose escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity * Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows: * 1 to < 2 years: 0.6 mg/dL * 2 to < 6 years: 0.8 mg/dL * 6 to < 10 years: 1.0 mg/dL * 10 to < 13 years: 1.2 mg/dL * 13 to < 16 years: 1.5 mg/dL (males); 1.4 mg/dL (females) * >= 16 years: 1.7 mg/dL (males); 1.4 mg/dL (females) * Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age * Serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L * Serum albumin >= 2 g/dL * All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines * Tissue blocks or slides must be sent; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment Exclusion Criteria: * Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible * Patients who are currently receiving another investigational drug are not eligible * Patients who are currently receiving other anti-cancer agents are not eligible * Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial * Patients must not be receiving any of the following for at least 24 hours prior to enrollment: omeprazole, esoprazole, lansoprazole, pantoprazole, rifampin, omeprazole, fluvoxamine, or moclobemide * Patients must not be receiving any of the following for at least 24 hours prior to enrollment: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole, rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, or St. John's Wort * Nasogastric or G tube administration is not allowed; patients in part A must be able to swallow capsules * Patients who have an uncontrolled infection are not eligible * Patients who have received a prior solid organ transplantation are not eligible * Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible * Patients with >= grade 2 bradycardia or with a known history >= grade 2 cardiac arrhythmia are not eligible

Study Objectives Bevacizumab in combination with chemotherapy represents a standard of care for first-line treatment in patients with advanced colorectal cancer. Molecular predictive factors for bevacizumab efficacy have not yet been identified therefore selection of patients more likely to benefit from such a treatment approach is not possible. Retrospective analyses suggested that LDH serum levels may influence the clinical activity of anti-angiogenetic drugs. Primary aim of our clinical trial will be to prospectively ascertain whether bevacizumab in combination with chemotherapy has an improved clinical activity in patients with high LDH serum levels compared to patients with normal LDH serum levels Conditions: Colorectal Cancer Stage II Intervention / Treatment: DRUG: Bevacizumab and FOLFIRI Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: SINGLE

Inclusion Criteria: * Written informed consent * No prior treatment for advanced disease (adjuvant therapy allowed) * age < 75 years < 18 years * Histologically/cytologically confirmed advanced, colorectal cancer * At least one lesion measurable with CT or MRI scan * Performance Status (ECOG) 0-1 at study entry) * Life expectancy of at least 6 months * Neutrophils count =/> 1.5 x 109/L, platelets count =/> 100 x 109/L, HGB =/> 10 g/dL * total bilirubin < 1.5 x UNL * SGOT and SGPT =/< 2.5 x UNL (=/< 5 x UNL in patients with liver metastases) * Creatinine < 1.5 x UNL Exclusion Criteria: * CNS metastases * Severe cardiovascular disease * Uncontrolled infections * Radiotherapy within 4 weeks of study entry * Any experimental drug administered within 4 weeks of study entry * Known hypersensitivity to study drug * Known drugs or alcohol abuse * Pregnant or lactating women (serum Betahcg test) * Other tumours, except in situ melanoma or cervix cancer if radically removed * Incapability to sign informed consent

Study Objectives Efficacy and safety of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism after hematopoietic stem cell transplantation. Conditions: Myeloid Leukemia, Myelodysplastic Syndrome Intervention / Treatment: DRUG: 5-Azacytidin Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Screening phase: * Age > 18 years * Patients with CD34+ AML or MDS post-allogeneic HSCT * Written patient consent after consultation Treatment phase * AML/MDS: donor chimerism < 80% in the CD34+ subpopulation following allogeneic HSCT in patients with CD34+ AML or MDS, but with no haematological relapse (blasts < 5% in bone marrow) * Leukocytes > 3 Gpt/l and platelets > 75 Gpt/l (transfusion-independent) Exclusion Criteria: * Known intolerance to 5-azacitidine or mannitol * Uncontrollable infectious disease * Patients with active hepatitis B or C or HIV infection * Severe hepatic function impairment (ASAT and ALAT may not be above three times the normal value) or hepatic cirrhosis, or malignant hepatic tumour * Renal function impairment (creatinine > twice the normal value, creatinine clearance < 50 ml/min) * Pregnancy or lactation * Women of childbearing age, except for those who meet the following criteria: * postmenopausal (12 months natural amenorrhoea) * postoperative (6 weeks after bilateral ovarectomy with or without hysterectomy) * regular and correct use of a contraceptive method with an error rate < 1% per year (e.g. implants, depot injections, combined oral contraceptives, intrauterine device - IUD, whereby hormonal coils with a Pearl Index of < 1% are safer than copper coils) * sexual abstinence * Partner vasectomy * Men who do not use one of the following for contraception: * sexual abstinence * post vasectomy * condoms * Participation of the patient in a drug trial outside the indication of allogeneic transplantation up to four weeks before study initiation * Addictive or other illnesses that prevent the person concerned from comprehending the nature and impact, as well as potentical consequences of the clinical trial * Evidence that the patient may intentionally not comply with the protocol, e.g. lack of cooperation With the exception of a known allergic reaction or intolerance to 5-azacitidine, these criteria do not apply to the screening phase.

Study Objectives The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The study will also explore the changes to various markers in blood cells and potentially tumor cells. Finally, the study will help document any antitumor activity this drug may have. In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in different types of cancer, including breast and lung cancer, lymphoma and mesothelioma. Conditions: Advanced Cancer, Metastatic Cancer, Non-Hodgkin's Lymphoma, Metastatic Breast Cancer, Malignant Mesothelioma, Non-small Cell Lung Cancer Intervention / Treatment: DRUG: LY3023414, DRUG: Midazolam, DRUG: Fulvestrant, DRUG: Pemetrexed, DRUG: Cisplatin, DRUG: Abemaciclib, DRUG: Letrozole Location: United States, Puerto Rico, Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Parts A, A2 & B1: Participants must have pathological evidence of a diagnosis of advanced and/or metastatic cancer and must be, in the judgment of the investigator, an appropriate candidate for experimental therapy * Part B2: Participants must have advanced, recurrent, or metastatic breast cancer that is refractory to aromatase inhibitors (AI) with either disease recurrence or disease progression; must be hormone receptor positive (HR+) and human epidermal growth factor receptor 2 (HER2)-negative; must be of postmenopausal status or beginning ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist * Part B3 only: Participants must have malignant pleural or peritoneal mesothelioma * Part B4 only: Participants must have malignant pleural or peritoneal mesothelioma and appropriate candidate for treatment with cisplatin/pemetrexed; no prior systemic chemotherapy * Part B5 only: Participants must have histologically confirmed diagnosis of B-cell iNHL, with histological subtype; prior treatment with >=2 prior chemotherapy- or immunotherapy-based regimens for iNHL * Part B6 only: Participants must have squamous NSCLC; documented evidence of an activating molecular aberration of the PI3K/mTOR pathway * Parts B2, B3 & B6 only: Must have adequate tumor tissue sample from archival biopsy available, or willingness to undergo a fresh tumor biopsy * Parts B3, B4, B5 & B6: No previous treatment with any PI3K and/or mTOR inhibitor * Part B7: Must have a diagnosis of HR+ and HER2- breast cancer; have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease; no previous treatment or currently receiving 1 of the following treatments for locoregionally recurrent or metastatic breast cancer (chemotherapy, endocrine therapy, CDK4/6 inhibitor, and PI3K and/or mTOR inhibitor) * Measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1), modified RECIST or Revised Response Criteria for Malignant Lymphoma * Have adequate organ function, including: Absolute neutrophil count (ANC) at least 1.5 x 109/Liter (L), platelets at least 100 x 109/L, and hemoglobin at least 8 grams/deciliter (g/dL); bilirubin no more than 1.5 times upper limits of normal; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no more than 2.0 times upper limits of normal; Serum creatinine no more than 1.5 times upper limits of normal or calculated creatinine clearance >45 milliliters/minute (mL/min) * Have a performance status of at least 1 on the Eastern Cooperative Oncology Group (ECOG) scale and life expectancy >6 months * Have discontinued all previous cancer therapies (except nonsteroidal aromatase inhibitors for participants in Part B2), and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 half lives prior to study enrollment, whichever is shorter, and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days * Are able to swallow capsules Exclusion Criteria: * Have serious preexisting medical conditions * Have symptomatic central nervous system (CNS) malignancy (with the exception of medulloblastoma) or metastasis (screening not required). * Have known acute or chronic leukemia or current hematologic malignancies (except iNHL for patients in Part B5) that, in the judgment of the investigator and sponsor, may affect the interpretation of results * Have an active fungal, bacterial, and/or known viral infection * Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results (Part B only) * Part B1 only: No concomitant medications that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) or midazolam * Intolerance to any previous treatment with any phosphatidylinositol-3-kinase (PI3K) and/or mammalian target of rapamycin (mTOR) inhibitor. * Participants with active alcohol abuse, as determined by the investigator * Have a history of New York Heart Association (NYHA) Class >=3, unstable angina, or myocardial infarction (MI) in 6 months prior to study drug administration * Have QT corrected interval of >450 milliseconds (msec) on screening electrocardiogram (ECG) * Have insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus. * Part B only: Hypersensitivity to study drugs given in combination with LY3023414

Study Objectives Project title: Influence of Vasopressors on Brain Oxygenation and Microcirculation in Anesthetized Patients with Cerebral Tumors Sponsor-investigator: Klaus Ulrik Koch M.D. Sponsor: Department of Anesthesia Aarhus University Hospital, Nørrebrogade 44, 8000 Aarhus C, Denmark Objective: To investigate whether phenylephrine and ephedrine causes different alterations in microcirculation and oxygenation, as measured with MRI and PET, in anesthetized patients with brain tumors. Using MRI and PET, the study will assess whether there is a difference in deoxyhemoglobin concentration (Bold signal), CTTH, cerebral blood flow (CBF) and cerebral metabolic rate of oxygen (CMRO2) between ephedrine and phenylephrine Method: Double blinded controlled randomized clinical trial. Either phenylephrine or ephedrine are infused intravenously under general anesthesia. MRI is performed in 20 patients before and after infusion. PET/CT is performed in 20 patients before and after infusion. BIS and NIRS monitoring will be used in either scanner. After scanning patients are transported to the operating theatre and the craniotomy is performed. After removal of the bone flap subdural ICP is measured and recorded. MRI to analyze CBF, CTH, max.CMRO2, maxOEF, CBV and grey-scale ADC before and after ephedrine and phenylephrine. PET/CT to analyze CBF and CMRO2 before and after ephedrine and phenylephrine and calculation of OEF. During each PET/CT scan session oxygen saturation and hemoglobin concentration is measured. Data from the proposed studies will add substantial new knowledge to the investigators current understanding of the effects of vasopressors on cerebral circulation. This information will aid the neuroanesthesiologist, neurointensivist and the neurosurgeon in the choice of the optimal method to manage cerebral perfusion pressure during craniotomy for brain tumor. Conditions: Brain Tumor Intervention / Treatment: DRUG: Ephedrine, DRUG: Phenylephrine Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Patients scheduled for supine-positioned elective craniotomy for supratentorial malignant and non-malignant brain tumors 3 cm or larger (measured as the largest diameter in any plane on MR images) * ASA (American Society of Anesthesiologist) status 1-3 (27) * Written informed consent from participating patients Exclusion Criteria: * Age younger than 18 yrs. or older than 75 yrs. * Pregnancy or nursing (negative pregnancy blood test) * History of allergic reactions to phenylephrine or ephedrine * eGFR < 60ml/min/1.73m2

Study Objectives Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells. A randomized, double-blind, single-dose, parallel phase I study comparing trastuzumab for injection with Herceptin ® in healthy male volunteers was conducted to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of Trastuzumab for injection and Herceptin®. Conditions: Metastatic Breast Cancer, Metastatic Gastric Cancer Intervention / Treatment: DRUG: Trastuzumab for injection, DRUG: Herceptin Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Fully understand the purpose of the trial, and have a basic understanding of the pharmacological effects and possible adverse reactions of the drug under study; Voluntary written informed consent in accordance with the Helsinki Declaration; * Healthy male subjects aged >= 18 years and <= 65 years; * Body weight >= 50 kg <= 90 kg, body mass index >= 18 <= 28kg/m2; * The system examination indicators were within the normal range, or the examination results were abnormal but the researchers judged that there was no clinical significance; * Subjects agree to use reliable contraceptive methods for both themselves and their partners during the study period and for 6 months after the study drug infusion. Exclusion Criteria: * History of hypertension or abnormal blood pressure at screening/baseline measurement; * A history of albuminuria or albuminuria as assessed by the investigator as clinically significant; * Received any antibody or protein targeting Vascular Endothelial Cell Growth Factor (VEGF) or VEGF receptors in the previous 1 year; * Study the use of any biological product or live virus vaccine within 3 months prior to drug infusion, or the use of any monoclonal antibody within 12 months; * Have an inherited tendency to bleed or have coagulation dysfunction, or have a history of thrombosis or bleeding; * History of digestive tract perforation or digestive tract fistula; * Unhealed wound ulcers or fractures, or major surgery within 2 months prior to randomization or expected to be performed during the study period or within 2 months after study completion; * Use of a prescription or over-the-counter drug or nutritional supplement within the 5 half-life of the drug or nutritional supplement or within 2 weeks prior to the study drug use; * Positive virology test; * Known allergy to trastuzumab; * Known history of allergic diseases or allergic constitution; * Study the history of blood donation 3 months before drug infusion; * Received any other investigational drug therapy or participated in another interventional clinical trial within 2 months prior to screening * A history of alcohol or drug abuse in the 12 months prior to screening; * A history of mental illness; * Subjects whose spouses plan to become pregnant; * The study cannot be completed according to protocol requirements during the study period; * Conditions considered unsuitable for inclusion by other researchers.

Study Objectives Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence. The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period. Conditions: Breast Cancer Intervention / Treatment: DRUG: propofol group, DRUG: sevoflurane group Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: BASIC_SCIENCE Allocation: RANDOMIZED Interventional Model: FACTORIAL Masking: QUADRUPLE

Inclusion Criteria: * patient who was planned to undergo colon cancer surgery. Exclusion Criteria: * age < 20 years old * history of hypersensitivity reaction in propofol or sevoflurane * history of previous cancer * patient with ongoing inflammation

Study Objectives This study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. Study patients will receive two additional courses of the standard chemotherapy combination after completing radiation therapy. Conditions: Lung Cancer, Small Cell, Small Cell Lung Cancer Intervention / Treatment: DRUG: topotecan Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have newly diagnosed, limited stage SCLC (small cell lung cancer), with no prior radiotherapy. Patients are allowed to have had a resection or biopsy. * Women of reproductive potential must have a negative serum pregnancy test at the study screening visit. * Patients must give written informed consent to participate in the study. * Patients must be able to take oral medication. * Patients should be completely recovered from recent surgery. * Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function. * Patients must be evaluated by the radiation oncologist prior to study entry. Exclusion Criteria: * Extensive Stage SCLC. * Women who are pregnant or lactating. * Use of an investigational drug within 30 days prior to the first dose of study medication. * Any medically/clinically significant active infection. * Symptoms of the SCLC spreading to the brain. * Patients with limited stage SCLC who have undergone complete resection with no measurable disease prior to starting chemotherapy. * Severe medical problems, unrelated to SCLC, that would limit the patient's full ability to follow all study rules and procedures, or that would expose the patient to extreme risk. * Other ongoing, immunotherapy or radiotherapy being administered at the time as study participation.

Study Objectives The purpose of this study is to determine the safety, toxicity and patient tolerance of STA-5312 administered intravenously to patients with relapsed or refractory hematological malignancies and patients with solid tumors. Conditions: Hematological Malignancies, Leukemia, Lymphoma, Metastatic or Unresectable Solid Tumors Intervention / Treatment: DRUG: STA-5312 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male and female patients >= 18 years with one of the following malignancies: * Histologically or cytologically confirmed hematological malignancy (other than Acute Myeloid Leukemia and Myelodysplastic Syndrome) and if treatment is medically indicated, or, * Histologically-confirmed non-hematological malignancy that is metastatic or unresectable and for which no standard therapy is available. * Patients with CLL, PLL, CML, CTCL, ATL, and Non-Hodgkin's Lymphoma may be entered if they are refractory to or have relapsed following conventional chemotherapy regimens such as alkylating agents (e.g. chlorambucil and cyclophosphamide), anthracycline combinations [e.g. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)], and/or purine analogues (e.g. fludarabine monophosphate and 2-CDA) and are not currently being considered for re-treatment with conventional regimens * Patients with CLL and other leukemic malignancies will be staged according to the modified Rai staging criteria [low-risk, intermediate-risk and high risk]. All patients in the high-risk group (Stage III and IV) are eligible. Intermediate risk patients (Stage I and II) with one or more criteria of active disease (such as progressive lymphocytosis, lymphadenopathy, and splenomegaly, weight loss > 10% within 6 months, extreme fatigue, fever and/or night sweats without evidence of infection, etc.) are also eligible * ECOG Performance Status of 0-2 * Life expectancy of greater than 12 weeks. * Patients must have acceptable organ and marrow function at screening and pre-dose visits as defined below unless approved medically by the clinical investigator. * Absolute neutrophils count greater than 1,000 cells/ul for patients with hematologic malignancies and >=1,500 cells/ul for patients with solid tumors * Platelets greater than 100,000/ul * Hgb greater than 8.5 g/dL * Total bilirubin must be <1.5 mg/dL or < 2X upper limit of normal * AST (SGOT) < 2.5 times the upper limit of normal * ALT (SGPT) < 2.5 times the upper limit of normal * Adequate renal function (serum creatinine < 2.0 mg/dL or a calculated creatinine clearance greater than 50 mL/min) * Electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator. * NCI grade 0-1 left ventricular ejection fraction within 30 days of dosing. * The effects of STA-5312 on the developing human fetus are unknown. Therefore, women of childbearing potential (defined as women under 50 years of age or history of amenorrhea for < 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Women who are pregnant or lactating. * Patients who have had chemotherapy, radiotherapy (except palliative radiation delivered to < 20% of bone marrow), immunotherapy, or corticosteroids ( > 10 mg/day of prednisone or equivalent) within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * The use of nitrosoureas or mitomycin C within 6 weeks prior to study entry. * Patients with prior peripheral blood stem cell rescue or bone marrow transplantation. * History of primary brain tumors or active brain metastases. (Patients with previously treated brain metastases who are not receiving corticosteroids or anticonvulsants may be considered for enrollment) * History of stroke or other significant neurologic limitations within 6 months prior to study enrollment * Use of any investigational agents within 4 weeks of study enrollment. * History of severe allergic reactions to excipients (e.g. Tween 80) or had hypersensitivity reactions to other chemotherapeutic agents similar in structure to STA-5312. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator. * History of active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe medical illness or infection. * Grade 2 or higher sensory or motor neuropathy at screening. * Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.

Study Objectives This study with pemetrexed is for patients with metastatic or unresectable pancreatic cancer who progressed after first line chemotherapy with gemcitabine. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: pemetrexed Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histological or cytological diagnosis of adenocarcinoma of the pancreas that is locally advanced (Stage II, III) or metastatic (Stage IV), as staged by the American Joint Committee on Cancer (AJCC; Protocol Attachment S041.2; Fleming et al. 1997), and not amenable to resection with curative intent. * Prior systemic first line chemotherapy with gemcitabine single agent or a combination regimen including gemcitabine (not more than one prior systemic chemotherapy allowed). * Uni-dimensionally measurable disease according to the RECIST criteria (Therasse et al. 2000), defined as: At least one lesion that can be accurately measured in at least one dimension, with the longest diameter greater than or equal to 2 cm with conventional techniques or greater than or equal to 1.0 cm with spiral CT scans. Ultrasound and X-ray are NOT allowed to measure or follow lesions. Exclusion Criteria: * Prior radiation of equal to or greater than 25% of the bone marrow (Cristy and Eckerman 1987) * Prior immunotherapy, biological therapy, and/or hormonal therapy for pancreas cancer. * Prior systemic chemotherapy with 5-FU. * Patient not yet recovered from the acute toxic effects of the treatment prior to study enrollment. * Radiotherapy within the last 4 weeks before study entry

Study Objectives This trial combines dose dense chemotherapy with doxorubicin and cyclophosphamide (AC) followed by standard, every 3 week docetaxel and GW572016 (lapatinib) for neoadjuvant treatment of Her2neu positive stage II/III breast cancer. The purpose of the study was to determine whether lapatinib combined with chemotherapy was safe and resulted in an increase in pathologic complete response rates. Conditions: Breast Cancer, Metastatic Breast Cancer Intervention / Treatment: DRUG: Lapatinib, DRUG: Doxorubicin, DRUG: Cyclophosphamide, DRUG: Docetaxel, DRUG: Pegfilgrastim, DRUG: Filgrastim, DRUG: Dexamethasone, DRUG: Trastuzumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

INCLUSION CRITERIA * Female * Histologically-confirmed Her2neu positive breast cancer, by either Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization (FISH)+ * Stage II/III breast cancer including any large primary tumor (> 2 cm), tumors of any size associated with skin or chest wall involvement, tumors of any size with axillary lymph node involvement, (T2-T4, N0-N2) and those with ipsilateral subclavicular or supraclavicular lymph nodes). * At least one bi-dimensional, measurable indicator lesion. * Between 18 and 70 years of age * Eastern Cooperative Oncology Group (ECOG) performance status <= 2 / Karnofsky >= 60% at screening and on the first day of treatment. * Informed consent must be obtained prior to registration. * Cardiac ejection fraction within the institutional range of normal as measured by multigated acquisition (MUGA) or echocardiography (ECHO) scan. * Absolute neutrophil count > 1,500/mm³ * Hemoglobin > 8.0 g/dL * Platelet count > 100,000/mm³ * Creatinine within normal institutional limits * Total Bilirubin equal to or less than institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST); alanine aminotransferase (ALT); and alkaline phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. * Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016 will be determined following review of their use by the Principal Investigator * Antacid use is prohibited 1 hour before and 1 hour after GW572016 dosing. * All herbal (alternative) medicines are prohibited. * Medications prohibited during the administration of lapatinib . * Women of child-bearing potential must have negative pregnancy test and must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. * Peripheral neuropathy: must be < grade 1 * Able to swallow and retain oral medication EXCLUSION CRITERIA * Evidence of disease outside the breast or chest wall, except for ipsilateral axillary , supraclavicular, or infraclavicular lymph nodes. * Prior chemotherapy, immunotherapy, or hormonal therapy for breast cancer. * More than 3 months between histologic diagnosis and registration on this study. * History of other malignancy within the last 5years, except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix. * Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol. Those who are medically-unstable, including but not limited to active infection, acute hepatitis, deep vein thrombosis requiring anticoagulant therapy, gastrointestinal bleeding, uncontrolled hypercalcemia, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome, and those whose circumstances do not permit completion of the study or the required follow-up. * Congestive heart failure, abnormal left ventricular ejection fraction (LVEF), angina pectoris, uncontrolled cardiac arrhythmias, or other significant heart disease, or who have had a myocardial infarction within the past year. * Pregnant or lactating * Of childbearing potential and not employing adequate contraception * History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016. * HIV-positive and receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated. * GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis). * History of severe hypersensitivity reaction to taxotere or other drugs formulated with polysorbate 80. * Current active hepatic or biliary disease (with exception of patients with Gilberts syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment ).

Study Objectives At step 1, patients with advanced solid tumors will receive CP-4126 capsules following a dose escalation schedule until the maximum tolerated dose is reached. At step 2, 20 patients will be randomized. They will receive at days 1 and 8 in a double cross design either oral CP-4126 at the recommended dose or gemcitabine 1000mg/m2 intravenously. At both steps, the schedule of treatment will be day 1, 8, 15 q4w until complete response or disease worsening/ progressing. All further treatment at step 2 will be oral CP-4126. Conditions: Solid Tumors Intervention / Treatment: DRUG: CP-4126, DRUG: Gemcitabine Location: Belgium, Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed solid tumour diagnosis * Locally advanced or metastatic disease, for which there is no known effective treatment * Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status * Age 18 years or more * Life expectancy > 3 months * Adequate hematological and biological functions: * Signed informed consent Exclusion Criteria: * Symptomatic brain metastases * Current peripheral neuropathy of grade > 1 according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 * Radiotherapy * to more than 30 % of bone marrow * single dose up to 8 Gy * less than one week prior to the study treatment * of the upper GI tract * Mucositis of the upper digestive tract, including stomatitis * Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study * Previous anticancer therapy (chemotherapy, hormone therapy or immunotherapy) within 30 days prior to the first dose of oral CP-4126 [6 weeks for mitomycin C and BCNU (= carmustine) and CCNU (=lomustine)] * Requirement of concomitant treatment with a non-permitted medication including alternative drugs and high doses of vitamins * History of allergic reactions to gemcitabine * Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection) * Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance * Pregnant or breast feeding women * Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for six months after last treatment * Known positive status for HIV and/or hepatitis B or C * Any reason why, in the investigator's opinion, the patient should not participate * Condition that impairs ability to swallow pills * Coeliac disease or any other lipid malabsorption syndrome * Drug and/or alcohol abuse

Study Objectives RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib and rituximab together works in treating patients with mantle cell lymphoma who have previously undergone stem cell transplantation Conditions: Contiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Stage I Mantle Cell Lymphoma, Stage III Mantle Cell Lymphoma, Stage IV Mantle Cell Lymphoma Intervention / Treatment: DRUG: bortezomib, BIOLOGICAL: rituximab, OTHER: laboratory biomarker analysis, OTHER: immunohistochemistry staining method, GENETIC: RNA analysis, GENETIC: gene expression analysis, GENETIC: DNA analysis, OTHER: pharmacological study, OTHER: pharmacogenomic studies, OTHER: Questionnaire Administration Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histological documented or cytological confirmed mantle cell lymphoma; cyclin D1 must be present as evidenced by either fluorescence in situ hybridization (FISH) or immunohistochemical staining * Patients must have undergone autologous hematopoietic stem cell transplantation (AHCT) and achieved engraftment by day (D)60-180 as evidenced by absolute neutrophil count (ANC) > 1000/mcL and platelets (Plt) > 75,000/mcL * Patients must be in complete remission at D60-180 after AHCT as evidenced by computed tomography (CT) scan of the neck/chest/abdomen (abd)/pelvis or CT/positron emission tomography (PET) scans * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study * Male subject agrees to use an acceptable method for contraception for the duration of the study * Life expectancy of greater than 3 months * Karnofsky > 60% * ANC > 1000/mcL * Plts > 75,000/mcL * Total bilirubin within normal institutional limits, patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x institutional upper limit of normal * Creatinine up to and including 2 mg/dL Exclusion Criteria: * Patient has >= grade 2 peripheral neuropathy within 14 days before enrollment and at D60-180 after AHCT; patients who had >= grade 2 peripheral neuropathy within 14 days before enrollment but resolves to grade 1 or lower peripheral neuropathy at D60-D180 after AHCT can be enrolled at this time * Patient has > 1.5 x upper limit of normal (ULN) total bilirubin unless history of Gilbert's syndrome * Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiographic (ECG) abnormality at screening has to be documented by the investigator as not medically relevant * Patient has hypersensitivity to bortezomib, boron or mannitol * Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women * Patient has received other investigational drugs with 14 days before treatment of treatment with bortezomib + rituximab * Serious medical or psychiatric illness likely to interfere with participation in this clinical study * Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy * Patients with other active malignancies (no evidence of other cancer or life expectancy greater than 5 years) are ineligible for this study * Human immunodeficiency virus (HIV) positive patients or hepatitis B or C positive patients * Patients with active central nervous system (CNS) disease or history of brain metastases (mets) are excluded from study * Prior exposure to either bortezomib or rituximab is not an exclusion criteria

Study Objectives This is a Phase I study to determine the effect of GW786034 (pazopanib) on P450 enzymes. This study will help determine which types of drugs may interact with GW786034. Conditions: Carcinoma, Renal Cell Intervention / Treatment: DRUG: GW786034 (pazopanib), DRUG: Probe drugs Location: United States, Singapore Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Histologically or cytologically confirmed diagnosis of advanced solid tumors. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate bone marrow, renal, lung, and liver function. * A female subject must not be pregnant and will agree not to become pregnant during the trial Exclusion criteria: * Any major surgery, chemotherapy, hormone therapy, investigational drugs, or radiotherapy within the last 28 days. * Poorly controlled hypertension. * Corrected QT (QTc) prolongation defined as a QTc interval greater than or equal to 480 msec and a prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities. * Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the last 3 months. * Current use of therapeutic anticoagulation (low molecular weight heparin, oral anticoagulant agents). Amiodarone must not have been taken for at least 6 months prior to the administration of the first dose of study drug. * History of brain metastases. * Has narrow-angle glaucoma which is a contraindication to midazolam use. * History of nicotine-containing product (including cigarettes, cigars, nicotine patches) use within the past 6 months. * A history of bleeding problems.

Study Objectives This phase 2 trial evaluates the benefit of epacadostat plus pembrolizumab in combination to treat patients with gastroesophageal junction or gastric cancer that has spread to other parts of the body and cannot be removed by surgery. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving epacadostat and pembrolizumab may work better in treating patients with gastroesophageal junction or gastric cancer. Conditions: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Recurrent Esophageal Carcinoma, Recurrent Gastric Carcinoma, Stage IV Esophageal Cancer AJCC v7, Stage IV Gastric Cancer AJCC v7, Unresectable Esophageal Carcinoma Intervention / Treatment: DRUG: Epacadostat, DRUG: Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

INCLUSION CRITERIA * >= 18 years of age on day of consent * Histologically-or cytologically-confirmed adenocarcinoma of the distal esophagus [within 5 centimeters of the gastroesophageal junction (GEJ)], gastroesophageal junction or stomach, including HER2+ disease * Metastatic or unresectable disease, including those with HER2+ disease * Progressed on at least 1 line of prior therapy for metastatic disease, or intolerant to that therapy if not progressed * If HER2+ disease, should have received prior trastuzumab * Life expectancy >= 12 weeks * Eastern Cooperative Oncology (ECOG) Performance Status 0 or 1 * Measurable disease per RECIST v1.1, assessed within 4 weeks prior to study entry * Tumor deemed amenable to biopsy by core for metastatic site or endoscopic biopsy for primary tumor (for both before and on-treatment biopsies) * Able to swallow pills * Female subject of childbearing potential should have a negative urine or serum pregnancy within 3 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Female subjects of childbearing potential must be willing to use an adequate method of contraception starting with the date of consent through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject * Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the date of consent through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject * Prior authorization by Merck in order to enroll in this study is required if previously treated on any Merck-sponsored pembrolizumab-containing gastric cancer pivotal trial * Willing to undergo 2 biopsies (before and on-treatment), provided the procedure is not deemed high-risk and is clinically feasible * Willing and able to provide written informed consent/assent EXCLUSION CRITERIA * Known additional malignancy that has progressed or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. EXCEPTION: subjects with previously-treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. Patients with prior CNS metastases treated with prior radiation therapy (RT) will also need ALL of the following: * 2 months off RT before starting study or 4 weeks following radiation therapy (XRT) if magnetic resonance imaging (MRI) is stable and the patient is off steroids * Baseline MRI with no edema * Stable for at least 8 weeks * Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication * Use of systemic corticosteroids * Currently, or within 4 weeks of the first planned dose of treatment, receiving an investigational agent and using an investigational device * Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1, or anyone has not recovered from adverse events (ie, to baseline or <= grade 1) due to agents administered more than 4 weeks earlier (EXCEPTION: denosumab for bone metastases is allowed) * Prior chemotherapy; targeted small molecule therapy; or radiation therapy within 2 weeks prior to study day 1 or who has not recovered from adverse events (ie, to baseline or <= grade 1) due to a previously administered agent (EXCEPTION: <= grade 2 neuropathy). Recovery from major surgery must be considered adequate prior to starting therapy. * Prior therapy with indoleamine-pyrrole 2,3-dioxygenase (IDO)-inhibitors * Prior therapy with monoamine oxidase inhibitors within 21 days before screening * Presence of a gastrointestinal condition that may affect drug absorption * Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents; corticosteroids; or immunosuppressive drugs). EXCEPTION: replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered systemic treatment * Known hypersensitivity to pembrolizumab and/or epacadostat or any of their excipients * Known allergy or reaction to any component of either study drug or formulation components * Received a live vaccine, including live attenuated vaccines (eg, Flu-Mist), within 30 days of planned start of study therapy. EXCEPTION: inactivated flu vaccines such as seasonal influenza vaccines for injection are allowed * Known active hepatitis B (eg, hepatitis B surface antigen [HBsAg] reactive) * Known active hepatitis C (eg, hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] detected) * Known history of active tuberculosis (Bacillus tuberculosis) * Known history of human immunodeficiency virus (HIV) (HIV 1-2 antibodies) * Known history of, or any evidence of active, non-infectious pneumonitis * History of serotonin syndrome after receiving 1 or more serotonergic drugs * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study * History or presence of an abnormal electrocardiogram (ECG) which, in the investigator's opinion, is clinically significant * Corrected QT Fredericia's formula (QTcF) >= 480 ms or presence of a left bundle branch block (LBBB); if the QRS duration > 120ms, the JTc can be used in place of the QTcF; the JTc must be < 340 ms * Active infection requiring systemic therapy * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with pre-screening or screening visit through 120 days after the last dose of study treatment * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

Study Objectives Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells. Adult patients with ALL in relapse have less than 10% probability of long term survival. The present study will test the response rate (partial and complete remission) of refractory ALL or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be given for a hematopoietic stem cell transplant. The use of G-CSF is justified by a possible increase in ADCC. Conditions: Acute Lymphocytic Leukemia Intervention / Treatment: DRUG: Alemtuzumab (CAMPATH 1H) associated to G-CSF Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients older than 15 years * Refractory ALL * ALL in relapse post chemotherapy or post transplant * ALL blast cells expressing CD 52 antigen at any time during the evolution of the disease. * Signed informed consent * Patients under social security coverage * Anti conceptional tablets in pre menopausal women. Exclusion Criteria: * Children below 15 years of age or aged 15 * Blast cells not expressing CD52 antigen (at all evaluations) * HIV positivity * ECOG Score 3 and 4 * Hypersensitivity to Alemtuzumab. * Pregnancy or breast feeding. * Other malignant disease in addition to ALL.

Study Objectives The purpose of this study is to explore the feasibility and acceptability of a brief, virtual, group-based cognitive-behavioral intervention for breast cancer survivors taking hormonal therapy. The intervention (STRIDE) aims to alleviate symptoms related to hormonal therapy or breast cancer, optimize medication-taking (i.e., adherence), and reduce distress. Conditions: Breast Cancer, Adherence, Medication Intervention / Treatment: OTHER: STRIDE, OTHER: Medication Monitoring Control Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Female * Age >= 21 years * Diagnosis of early-stage (Stage 0-IIIb), hormone receptor + breast cancer * Within 1 week-36 months of starting adjuvant endocrine therapy * Ability to read and respond in English * Eastern Cooperative Oncology Group (ECOG) performance status <= 2 * Currently taking adjuvant endocrine therapy (i.e. if took recent break, has taken within the past 2 weeks) * Completed primary treatment (i.e., chemotherapy, surgery, and/or radiation) for early-stage breast cancer * Indicates a score >=4 on one of the three NCCN adapted distress thermometer study screening questions Exclusion Criteria: * Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year * Cognitive impairment that prohibits participation in the study * Enrollment in a different clinical trial for breast cancer * Current participation in formal group psychotherapy or other psychosocial intervention trial * Undergoing primary treatment for other cancer (i.e., advanced stage cancer)

Study Objectives This phase II trial is studying alvocidib and oxaliplatin to see how well they work when given with or without fluorouracil and leucovorin calcium in treating patients with relapsed or refractory germ cell tumors. Drugs used in chemotherapy, such as alvocidib, oxaliplatin, fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving alvocidib together with oxaliplatin with or without fluorouracil and leucovorin calcium may kill more tumor cells. Conditions: Recurrent Extragonadal Seminoma, Recurrent Malignant Extragonadal Germ Cell Tumor, Recurrent Malignant Extragonadal Non-Seminomatous Germ Cell Tumor, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Ovarian Germ Cell Tumor, Stage III Testicular Cancer, Stage IV Extragonadal Non-Seminomatous Germ Cell Tumor, Stage IV Extragonadal Seminoma, Stage IV Ovarian Germ Cell Tumor Intervention / Treatment: DRUG: Alvocidib Hydrochloride, DRUG: Fluorouracil, DRUG: Leucovorin Calcium, DRUG: Oxaliplatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed germ cell tumor (GCT) * Seminoma or non-seminoma * Progressive disease after prior cisplatin-based therapy AND meets 1 of the following criteria: * Not considered to be a candidate for potentially curative therapy * Previously treated with high-dose chemotherapy regimens * Does not wish to undergo potentially curative high-dose therapy * Measurable or evaluable disease, as defined by 1 of the following criteria: * Unidimensionally measurable metastatic disease, defined as >= 1 malignant tumor mass that can be accurately measured in >= 1 dimension as >= 20 mm by conventional CT scan or MRI or as >= 10 mm by spiral CT scan * Bone lesions, ascites, peritoneal carcinomatosis, miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable disease * Patients with measurable disease only (i.e., normal tumor markers) must have >= 1 site of disease that has not been previously irradiated * Elevation of alpha-fetoprotein > 15 ng/mL and/or elevation of beta-human chorionic gonadotropin > 2.2 mIU/L * If tumor markers are not elevated, >= 1 site of measurable disease must be present * No known untreated CNS metastasis or primary CNS tumor * Patients who have undergone local treatment for brain metastases and whose brain metastases are demonstrated to be stable by repeat imaging studies performed >= 4 weeks after treatment are eligible * Karnofsky performance status 70-100% * ANC >= 1,000/mm^3 * Platelet count >= 100,000/mm^3 * Hemoglobin >= 8.0 g/dL * Serum creatinine <= 2.0 times upper limit of normal (ULN) * Total serum bilirubin <= 1.5 times ULN * AST and ALT <= 2.5 times ULN (unless elevation is due to underlying malignancy) * Not pregnant or nursing * Negative pregnancy test by ultrasound * Fertile patients must use effective contraception * Willing and able to comply with scheduled study visits, treatment plans, laboratory tests, follow-up tests for safety or effectiveness, and other study procedures * Mediport or Broviac access required for patients enrolled in part B of the study * No serious active infections * No significant (>= grade 2) or persistent ongoing toxicity, including peripheral neuropathy, from prior therapy * None of the following within the past 6 months: * Myocardial infarction * Severe/unstable angina * Coronary/peripheral artery bypass graft * Symptomatic congestive heart failure * Cerebrovascular accident or transient ischemic attack * Pulmonary embolism * No contraindication to any of the study drugs * No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, interfere with the interpretation of study results, and, in the judgement of the investigator, may make the patient inappropriate for study entry * No concurrent anti-retroviral therapy for HIV-positive patients * Recovered from prior radiotherapy or surgery * Residual grade 1 toxicities allowed * No prior alvocidib * At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), immunotherapy, or radiotherapy * More than 4 weeks since prior major surgery * No other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy * No concurrent participation in another investigational treatment clinical trial * Concurrent participation in supportive care trials or non-treatment trials (e.g., quality of life or laboratory analysis studies) allowed * No concurrent vitamins, antioxidants, herbal preparations, or supplements, except for a single-tablet multivitamin

Study Objectives The study is designed to determine the 32 month rate of distant relapse in patients with uveal melanoma who are at high risk of recurrence following definitive therapy with surgery or radiation who receive adjuvant crizotinib; and secondarily, the overall survival and disease specific survival in this patient population. Conditions: Uveal Melanoma Intervention / Treatment: DRUG: Crizotinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Primary diagnosis of uveal melanoma at least 12 mm in largest basal diameter as clinically determined by the treating investigator. Cytologic determination of diagnosis is not required. Size is based on clinical assessment (e.g. by ultrasound or direct ophthalmoscopy) prior to enucleation or radiation therapy. * Definitive therapy of the primary uveal melanoma must have been performed within 90 days of initiating protocol therapy. * High-risk (class 2) uveal melanoma as determined by gene expression profiling * No evidence of metastatic disease. * Age >=18 years. * Eastern Cooperative Oncology Group (ECOG) performance status <= 1 (Karnofsky >= 70%. * Life expectancy of greater than 3 months. * Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels * Patients must have normal organ and marrow function as defined below: * Absolute neutrophil count (ANC) >1,000 cells/mm³ * Platelet count >75,000/mm³ * Hemoglobin >9.0g/dL * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) <3x upper limited of normal (ULN) * Total bilirubin <2x ULN * Alkaline phosphatase <3x ULN * Serum creatinine <2x ULN or a creatinine clearance > 60mL/min * Note: Patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal investigator. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until 4 months after completion of crizotinib administration. Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study therapy, and 4 months after completion of crizotinib administration. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * History of another malignancy except for those who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies not requiring active therapy, are eligible. Consult the study Principal Investigator if unsure whether second malignancies meet the requirements specified above. * Any major surgery or extensive radiotherapy (except that which is required for definitive treatment of primary uveal melanoma), chemotherapy with delayed toxicity, biologic therapy, or immunotherapy within 21 days prior to initiation of study therapy. * History of prior crizotinib use. * Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study therapy and during the study. * Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to crizotinib. * Concurrent administration of crizotinib and a strong inhibitor or inducer of CYP3A is not permitted. Many over-the-counter and dietary supplements also inhibit or induce CYP3A and thus are prohibited. * A QT interval corrected for heart rate using the Bazett's formula QTcB >= 480 msec. * Concurrent administration of crizotinib and agents that can cause QTc prolongation is not permitted. * Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection, which will be allowed). HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with crizotinib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Study Objectives This phase II trial studies how well pemetrexed disodium and carboplatin work in treating patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Conditions: Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma Intervention / Treatment: DRUG: Carboplatin, OTHER: Laboratory Biomarker Analysis, DRUG: Pemetrexed Disodium Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have a histopathologically confirmed diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube carcinoma * Patients must have received at least 1 prior platinum and taxane based chemotherapy regimen; patients may have failed no more than 2 prior chemotherapy regimens * Patients must have "platinum sensitive" disease, which will be defined as those patients with relapsed disease who had an initial complete remission, and relapsed more than 6 months after completion of initial platinum based chemotherapy * Recurrent disease must be confirmed by: * Bidimensionally measurable disease which can be measured by physical examination or by means of medical imaging techniques (measurable disease) * Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be >= 2.0 cm when measured by conventional techniques, including palpation, x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or >= 1.0 cm when measured by spiral CT; all measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total representative of all involved organs should be identified as target lesions and will be recorded and measured at baseline; all baseline evaluations of disease status should be performed as close as possible to the start of treatment and never more than 4 weeks before the beginning of treatment * Target lesions should be selected on the basis of their size (lesions with the longest dimension, LD) and their suitability for accurate repetitive measurements by one consistent method of assessment (either clinically or by imaging techniques); a sum of LD for all target lesions will be calculated and reported as the baseline sum LD; the baseline sum LD will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease; all other lesions (or sites of disease) should be identified as non-target lesions and should also be recorded at baseline OR * Two confirmed serum cancer antigen-125 (CA-125) levels greater than or equal to 70 u/ml (or 2 x upper limit of normal) separated by 1 week and obtained within 4 weeks prior to entry to the study (evaluable disease) * Patients must not have had other myelosuppressive therapy within four weeks of initiating pemetrexed/ carboplatin therapy * Patients must have recovered from effects of recent surgery * Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 * White blood cell (WBC) greater than or equal to 3,000/ul * Platelet count greater or equal to 100,000/ul * Neutrophil count greater or equal to 1,500/ul * Creatinine clearance >= 45 ml/min (estimated creatinine clearance by Cockcroft-Gault equation acceptable) * Total bilirubin =< to 1.5 mg/dL * Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< three times the upper normal institutional limits; if patient has known hepatic metastases, patients may be enrolled if liver function test is =< five times the upper normal institutional limits * Alkaline phosphatase =< three times the upper normal institutional limits; if patient has known hepatic metastases, patients may be enrolled if liver function test is =< five times the upper normal institutional limits * Patient must have signed informed consent * Patients must be willing to take the dexamethasone, folic acid and vitamin B12 supplementation as indicated in the protocol to reduce adverse drug toxicity * Patients must be willing to interrupt aspirin and other nonsteroidal anti-inflammatory drugs (NSAID) intake for 2 days before, day of, and 2 days after each chemotherapy treatment; low dose 80 mg aspirin and cyclooxygenase-2 (Cox-2) inhibitors are excluded from this restriction; if concomitant administration of an NSAID is necessary, patients should be monitored closely * Patients must have a life expectancy of greater than 12 weeks * Patients may not have concurrent or previous invasive malignancies, with the exception of non-melanoma skin cancer or no evidence of recurrence of previous malignancy within the last 5 years * Patients must have a current exam, blood work and any clinically indicated imaging studies within 4 weeks prior to study enrollment * Baseline folate and homocysteine blood levels * The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta * The ability to take folic acid, vitamin B12, and dexamethasone according to protocol Exclusion Criteria: * Patients who have had more than two prior chemotherapeutic regimens * Patients who have had prior treatment with pemetrexed * Patients with a GOG performance status of 3 or 4 * Patients with >= grade 2 neuropathy * Patients who have received external beam whole pelvic or whole abdominal radiation treatment (>= 4500 centigray [cGy]) which would limit vascular capacity and reduce adequate drug delivery * Patients with evidence of recurrence from another malignancy within the previous five years * Patients with a concomitant malignancy other than squamous cell skin cancer * Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements * Patients who have received an investigational drug within the last 30 days that has not received regulatory approval * Presence of third space fluid which cannot be controlled by drainage; for patients who develop or have baseline clinically significant pleural or peritoneal effusions (on the basis of symptoms or clinical examination) before or during initiation of Alimta therapy, consideration should be given to draining the effusion prior to dosing; however, if, in the investigator's opinion, the effusion represents progression of disease, the patient should be discontinued from study therapy

Study Objectives To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of moderate to severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy BV (bleomycin/vincristine). To evaluate the safety and tolerance of DOX-SL compared to BV in a population of AIDS patients with moderate to severe KS. Conditions: Sarcoma, Kaposi, HIV Infections Intervention / Treatment: DRUG: Doxorubicin hydrochloride (liposomal), DRUG: Bleomycin sulfate, DRUG: Vincristine sulfate Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Interventional Model: PARALLEL

Inclusion Criteria Concurrent Medication: Allowed: * Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month. * Maintenance therapy for tuberculosis, fungal, and herpes infections. * Therapy for new episodes of tuberculosis, fungal, and herpes infection except with potentially myelotoxic chemotherapy. * Foscarnet for cytomegalovirus infection. * Erythropoietin. Patients must have: * Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following: * At least 15 mucocutaneous lesions. * Six or more new lesions in the prior month. * Documented visceral disease with at least five accessible cutaneous lesions. * Documented anti-HIV antibody. * No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if REQUIRING treatment with myelotoxic drugs). * Life expectancy > 4 months. NOTE: * Patients who fail the BV combination or who relapse are eligible to enter the Liposome Technology open trial using DOX-SL alone. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Clinically significant cardiac disease. * Confusion, disorientation, CNS symptoms, or peripheral neuropathy. Concurrent Medication: Excluded: * Other cytotoxic chemotherapy. * Colony-stimulating factors. * Ganciclovir. Patients with the following prior conditions are excluded: * Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function. * History of idiosyncratic or allergic reaction to anthracyclines, bleomycin, or vincristine. * History of major psychiatric illness. Prior Medication: Excluded: * Cytotoxic chemotherapy or interferon therapy within the past 4 weeks. * More than one prior cycle of bleomycin/vincristine at any time. Prior Treatment: Excluded: * Radiation or electron beam therapy within the past 3 weeks.

Study Objectives RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with vinorelbine may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when given together with vinorelbine in treating patients with advanced solid tumors. Conditions: Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: lapatinib ditosylate, DRUG: vinorelbine ditartrate, GENETIC: comparative genomic hybridization, GENETIC: cytogenetic analysis, GENETIC: gene expression analysis, GENETIC: mutation analysis, GENETIC: polymerase chain reaction, GENETIC: polymorphism analysis, GENETIC: proteomic profiling, GENETIC: reverse transcriptase-polymerase chain reaction, OTHER: immunohistochemistry staining method, OTHER: laboratory biomarker analysis, DRUG: lapatinib ditosylate, DRUG: Vinorelbine ditartrate Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Cytologically or histologically proven advanced solid tumors for which there is no known standard therapy available or are not eligible for standard therapy because of their performance status, or have progressed after no more than 2 prior chemotherapy regimens for metastatic disease. * Measurable or evaluable disease. Disease in previously irradiated sites is considered measurable if there is clear disease progression following radiation therapy. * 18 years of age or older. * Zubrod performance status of 0-2. * Estimated survival of at least 3 months. * Any prior chemotherapy must have been completed at least 4 weeks prior to start of this protocol and all side effects (except alopecia) resolved to grade 1 or less. Any prior radiation must have been completed at least 2 weeks prior to start of therapy. For prior mitomycin chemotherapy a 6-week interval is required. Patients must have completed prior trastuzumab at least 4 weeks prior to start of protocol therapy. * Adequate renal function * Adequate liver function * Pretreatment granulocyte count of >1500/mm3 and platelet count of >100 000/mm3. * Cardiac ejection fraction within the institutional range of normal as measured by 2-D echocardiogram or MUGA scan. * Asymptomatic treated brain metastasis may be included if they are neurologically stable and have been off steroids and anticonvulsants for at least 4 weeks. * All patients must give informed consent. * Able to take and retain oral medication. * Patients of reproductive potential must agree to use an effective contraceptive method Exclusion Criteria: * Patients may not have previously received lapatinib, vinorelbine or any other EGFR-1 targeted agent. Prior trastuzumab is allowed. * Females cannot be pregnant or breastfeeding * Symptomatic brain metastasis or still requiring steroids and anticonvulsants may not participate. * Pre-existing neuropathy > grade 2 may not participate. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, will be excluded. * History of other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications. * Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, or prior surgical procedures affecting absorption. * HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib. * Patients requiring oral anticoagulants are eligible provided there is appropriate close INR monitoring is in place. If medically appropriate and treatment available, the investigator may also consider switching these patients to LMW heparin, where an interaction with lapatinib is not expected. * Adherence to the requirements for concomitant medications classified as CYP3A4 inducers or inhibitors, or gastric pH modifiers

Study Objectives The goal of this clinical research study is to learn if combining cord blood units will be safe and result in the cells "taking" faster in recipients. The cord blood units will have their cell number increased in the lab using cells from a family member or they will be collected from an unrelated healthy donor. Conditions: Myelodysplastic Syndrome, Leukemia Intervention / Treatment: PROCEDURE: Cord Blood Infusion, DRUG: Busulfan, DRUG: Fludarabine, DRUG: Rituximab, OTHER: ATG, DRUG: Cyclophosphamide, DRUG: Clofarabine, RADIATION: Total Body Irradiation (TBI), DRUG: Melphalan, DRUG: Tacrolimus, DRUG: Mycophenolate Mofetil, DRUG: G-CSF Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have one of the following hematologic malignancies: Acute Myelogenous Leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics, flt3 mutation positive and/or evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and/or arising from MDS, Langerhan's cell histiocytosis, any disease beyond first remission; or, * Myelodysplastic Syndrome (MDS): Primary or therapy related; or, * Acute Lymphoblastic Leukemia (ALL): induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease. * #3, continued: Patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and/or evidence of minimal residual disease, or acute biphenotypic leukemia, or double hit non-Hodgkin's lymphoma; or, * Non-Hodgkin's Lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant). Double hit lymphomas in first remission or more advanced disease; or, * Small Lymphocytic Lymphoma (SLL), or Chronic Lymphocytic Leukemia (CLL) with progressive disease following standard therapy; or, * CML second chronic phase or accelerated phase; or, * Hodgkin's Disease (HD): Induction failures, second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant); or, * Multiple Myeloma: stage II or III, symptomatic, secretory Multiple Myeloma requiring treatment. * Age greater than or equal to 1 year but less than or equal to 55 years (Myeloablative Regimen 4). Eligibility for pediatric patients will be determined in conjunction with an MD Anderson Cancer Center (MDACC) pediatrician. Patients >55 but < 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s). * Age greater than 55 years and less than or equal to 80 years (Nonmyeloablative Regimen 2) * Age greater than or equal to 1 but less than or equal to 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive reduced intensity regimen 3. * Performance score of at least 60% by Karnofsky or PS less than 3 (ECOG) (age greater than or equal to 12 years), or Lansky Play-Performance Scale of at least 60% or greater (age <12 years) * Left ventricular ejection fraction of at least 40% (Myeloablative Regimen 4, Reduced Intensity Regimen 3) or 30% (Nonmyeloablative Regimen 2) * Pulmonary function test demonstrating a diffusion capacity of least 50% predicted (Myeloablative Regimen 4, Reduced Intensity Regimen 3) or at least 40% predicted (Nonmyeloablative Regimen 2). For children < 7 years of age who are unable to perform pulmonary function test (PFT), oxygen saturation > 92% on room air by pulse oximetry. * Creatinine < 1.6 mg/dL (Myeloablative Regimen 4, Reduced Intensity Regimen 3) or < 3.0 mg/dL (Nonmyeloablative Regimen 2). * Serum glutamate pyruvate transaminase (SGPT)/bilirubin <= to 2.0 x normal (Myeloablative Regimen 4, Reduced Intensity Regimen 3) or <= 4.0 x normal (Nonmyeloablative Regimen 2) * Negative Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on study. * Unrelated Cord Blood will be used as a source of hematopoietic support if a 5 or 6/6 related or 6/6 unrelated bone marrow donor is not available, or if the tempo of a patient's disease dictates it is not in the patient's best interest to wait for an unrelated marrow donor to be procured. * Patients must have two Cord Blood units available which are matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. Each cord must contain at least 10 million total nucleated cells/Kg recipient body weight (pre-thaw) * Patients must have a family member who is matched at 2, 3, or 4 HLA antigens typed as described above and willing to donate 80-100 ml or bone marrow for MSC generation or the Angioblast Mesenchymal Precursor Cells will be used for the cord blood co-cultures. Patients that are high risk for relapse are eligible to use the Angioblast "off-the-shelf" Mesenchymal Precursor Cells. * Have identified a back-up cell source in case of engraftment failure. The source can be autologous, related, or unrelated. Exclusion Criteria: * HIV positive * Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding. * Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation. (excluding primary disease for which CB transplantation is proposed), or psychiatric condition that would limit informed consent. * Active central nervous system (CNS) disease in patient with history of CNS malignancy. * Availability of appropriate, willing, HLA-matched related marrow donor.

Study Objectives Breast cancer is one of the most common cancers seriously afflicting women in the United States. Of the one million incident cases that are reported annually there are approximately 193,000 new cases of breast cancer (Greenlee, 2001). Although significant advances have been made both in early detection and treatment of breast cancer, the impact of these on reduction in mortality has been modest (Peta, 2000). Furthermore, despite data implicating diet and other environmental risk factors, no lifestyle changes have yet been shown to significantly reduce the risk of breast cancer. Therefore, chemoprevention of breast cancer is a worthwhile approach to reduce the incidence of breast cancer. There is every reason to believe that a detailed understanding of the initiation, promotion and growth of breast cancer will ultimately provide a rational strategy upon which to base prevention strategies. While the pathways of breast cancer development are not yet fully understood, a role for estrogens in breast cancer etiology has been well established. While many pathways are involved in breast cancer etiology, including loss of tumor suppressor function by p53 or BRCA1 and gain of HER2 oncogene expression, their exact role in an individual patient's cancer development may vary. Therefore, it may be advantageous to focus on a chemoprevention strategy that may have a more uniform impact on breast cancer development, such as estrogen exposure. Estrogen and its metabolites, both in the circulation and locally synthesized in the breast, are important in the pathogenesis of breast cancer. High levels of circulating estrogen in postmenopausal women have been associated with an increased risk of breast cancer (Clemons, 2001). Furthermore, local estrogen synthesis, i.e. aromatase activity, in the breast may also be important in the development of breast cancer. Conditions: DCIS Intervention / Treatment: DRUG: Anastrozole Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have suspicion of DCIS or early invasive breast cancer on mammography. * Patients must have histologically confirmed diagnosis of DCIS or early invasive breast cancer on core biopsy for final registration. * Patients must be over 18 years of age * "Patients must be postmenopausal as defined by one of the following criteria: 1. Prior bilateral oophorectomy OR 2. > 12 months since LMP with no prior hysterectomy OR 3. a & b not applicable AND age >=50 * Patients must be positive for either ER or PR or both * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: * Patients must not have diagnosis of osteoporosis (T-score -2.5 according to the WHO)

Study Objectives This phase II, single-center study will assess the efficacy of pembrolizumab + nab-paclitaxel in patients who have metastatic urothelial tumor and do not respond to chemotherapy. The time between drug administration and progression of the disease will be assessed to determine if the drug will work. Conditions: Metastatic Urothelial Carcinoma Intervention / Treatment: DRUG: Pembrolizumab and Nanoparticle Albumin-bound Paclitaxel Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Be willing and able to provide written informed consent/assent for the trial, and be willing and able to follow trial procedures. * Be 18 years-old on day of signing informed consent. * Have an histologically-confirmed diagnosis of UC of the bladder or the urothelium, originating from either the bladder or the urinary tract (including upper tract), with predominant (>50%) UC component if other divergent histologies (e.g. squamous cell carcinoma, adenocarcinoma, small cell carcinoma) are found. * Have a life expectancy of at least 12 weeks. * Have experienced failure of 1 or 2 platinum-based conventional chemotherapy regimens for metastatic disease (2nd-to-3rd line only); a relapse should be occurred within 6 months from the last cycle of chemotherapy. * Have measurable disease based on RECIST 1.1. * Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may provide an archived specimen. * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. * Demonstrate adequate organ function. * (Female subject of childbearing potential) Have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * (Female subjects of childbearing potential ) Be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. * (Male subjects of childbearing potential) Agree to use an adequate method of contraception, starting from the first dose of study therapy through 120 days after the last dose of study therapy. Exclusion Criteria: * Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment * Has a known history of active Bacillus Tuberculosis * Had prior administration of taxane-based chemotherapy * Is taking regular oral steroids, above the allowed limit of 10mg/day methylprednisolone or analogues, for any reason. Patients must not have had steroids for 28 days prior to study entry * Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., Grade <=1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier * Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to a previously administered agent * Note: Subjects with Grade <=2 neuropathy are an exception to this criterion and may qualify for the study * Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability * Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment * Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Has an active infection requiring systemic therapy. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) * Has known active Hepatitis B or Hepatitis C * Has received a live vaccine within 30 days of planned start of study therapy

Study Objectives This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day cycles. Conditions: Leukemia, Amyloidosis Intervention / Treatment: DRUG: Lenalidomide, DRUG: Melphalan, DRUG: Dexamethasone Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

INCLUSION CRITERIA * Newly diagnosed or relapsed AL amyloidosis * Biopsy-proven amyloidosis with evidence of an underlying plasma cell dyscrasia * abnormal clonal dominance of plasma cells in the bone marrow * detection of a monoclonal gammopathy by immunofixation electrophoresis of serum and/or urine * an abnormal serum free light chain or ratio, or AL fibrils seen on biopsy) * Measurable disease defined by an abnormal serum-free light chain or monoclonal protein by immunofixation * proteinuria >= 0.5 g/day, cardiac involvement with interventricular septal thickness >= 15 mm * hepatomegaly in the absence of congestive heart failure with elevated alkaline phosphatase * Age >= 18 years at the time of signing the informed consent form. * All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study * ECOG performance status of <= 3 at study entry * Laboratory test results: * Absolute neutrophil count >= 1.0 x 10e9 / L * Platelet count >= 75 x 10e9 / L * Creatinine clearance >= 15 mL/ minute * Total bilirubin <= 2-fold upper limits of normal * Disease-free of prior malignancies (excluding multiple myeloma) for >= 3 years with exception of: * currently treated basal cell * squamous cell carcinoma of the skin * carcinoma "in situ" of the cervix or breast. * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test * Females of childbearing potential must either: * commit to continued abstinence from heterosexual intercourse * acceptable methods of birth control and agree to ongoing pregnancy testing * Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy * All study participants must be registered into the mandatory RevAssist program, and able to comply with its requirements * Able to take aspirin (81 mg) daily * Understand and voluntarily sign an informed consent form * Able to adhere to the study visit schedule and other protocol requirements EXCLUSION CRITERIA * Any serious medical condition that would prevent the subject from signing the informed consent form * Pregnant * breast-feeding females * Use of any other experimental drug or therapy within 28 days of baseline * Known hypersensitivity to thalidomide * Erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs * Any prior use of lenalidomide * Concurrent use of other anti-cancer agents or treatments * Known positivity for human immunodeficiency virus HIV)

Study Objectives This phase II trial studies how well metformin hydrochloride, leucovorin calcium, fluorouracil, and oxaliplatin work in treating patients with metastatic pancreatic cancer. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving metformin hydrochloride together with combination chemotherapy may kill more tumor cells Conditions: Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer Intervention / Treatment: DRUG: metformin hydrochloride, DRUG: oxaliplatin, DRUG: leucovorin calcium, DRUG: fluorouracil, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (or any mixed pathology if adenocarcinoma is predominant) * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan * Patient must have not received systemic chemotherapy for metastatic disease; prior chemotherapy, radiation therapy, concurrent chemoradiation are allowed if used for treatment of non-metastatic disease; prior palliative radiation for symptom management is allowed; any chemotherapy must have been completed 4 weeks prior to enrollment; any radiotherapy must have been completed 2 weeks prior to enrollment * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count >= 1,500/L * Platelets >= 100,000/L * Hemoglobin >= 9 g/dL * Total bilirubin <= 2 mg/dL * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) <= 2.5 x institutional upper limit of normal * Creatinine <= 1.5 * Women of childbearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately * Subjects must have the ability to understand and the willingness to sign a written informed consent document * Patients with diabetes are eligible for this trial; all diabetic patients who are enrolled on this study should discuss the need to change their diabetes management regimen with their primary care physician or endocrinologist prior to enrollment * Diabetic patients who are on metformin are eligible as long as they have been on metformin for less than 6 months (estimated 6 months or less duration of metformin therapy from start of metformin to enrollment on study) Exclusion Criteria: * Chemotherapy within 4 weeks prior to entering the study, radiotherapy within 2 weeks prior to entering the study or failure to recover from adverse events due to agents administered more than 4 weeks earlier * Prior treatment toxicities must be resolved to <= grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 * Current use of metformin for more than 6 months prior to enrollment on study * Use of any other investigational agents * Patients with untreated brain metastases should be excluded from this clinical trial * History of allergic reactions attributed to compounds of similar chemical or biological composition to metformin or oxaliplatin or fluorouracil (5-FU) * Active second primary malignancy or history of second primary malignancy within the last 3 years, with the exception of basal cell skin cancers or carcinoma in situ that have been adequately treated * Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing women * Human immunodeficiency virus (HIV)-positive patients * Chronic or planned acute alcohol use of three or more drinks per day * Metabolic acidosis, acute or chronic, including ketoacidosis

Study Objectives Context: Metformin administration in women with polycystic ovary syndrome (PCOS) improves hormonal and metabolic patterns with beneficial effects in terms of reproductive outcomes and intermediate cardiovascular disease risk factors. Furthermore, reduced folate and vitamin B12, and increased homocysteine (Hcy) levels have been found in type-2 diabetes mellitus patients treated with metformin. Objective: To evaluate if metformin administration exerts any effects on Hcy levels, and if folate supplementation may improve endothelial structure and function in PCOS patients. Conditions: Polycystic Ovary Syndrome, Anovulation Intervention / Treatment: DRUG: Folate plus metformin, DRUG: Placebo plus metformin Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: PREVENTION Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * PCOS Exclusion Criteria: * age <18 or >35 years * BMI >35 kg/m2 * neoplastic, metabolic, hepatic, renal, and cardiovascular disorders * Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.

Study Objectives This phase I trial studies the side effects and the best dose of veliparib when given together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and bevacizumab in treating patients with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has returned after previous treatment. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride and carboplatin, may stop the growth of tumor cells by, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth by blocking the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumors by blocking the growth of new blood vessels necessary for tumor growth. Giving veliparib together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and bevacizumab may kill more tumor cells. Conditions: Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Cystadenocarcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Undifferentiated Ovarian Carcinoma Intervention / Treatment: BIOLOGICAL: Bevacizumab, DRUG: Carboplatin, OTHER: Laboratory Biomarker Analysis, DRUG: Pegylated Liposomal Doxorubicin Hydrochloride, DRUG: Veliparib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma which is now recurrent; histologic documentation of the original primary tumor is required via the pathology report * Patients with the following histologic epithelial cell types are eligible: high-grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma or adenocarcinoma not otherwise specified (N.O.S.) * Patients must have recurrence documented by elevated cancer antigen (CA)-125 (biochemical recurrence) or clinically evident measurable or non-measurable recurrent disease * Biochemical recurrence is defined as a CA-125 greater than or equal to two times the upper normal limit; patients whose CA-125 is less than 100 U/mL must undergo a second confirmatory value within a period of not more than 4 weeks; patients with a level greater than or equal to 100 U/mL may be entered without confirmatory measurement; the CA-125 assessment for eligibility must be done at least 4 weeks after paracentesis or other surgical procedures * Detectable (non-measurable) disease is defined as symptomatic ascites or pleural effusions, solid and/or cystic abnormalities on radiographic imaging that do not meet Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 definitions for target lesions and/or biopsy proven recurrence * Measurable disease will be defined by RECIST 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI * Patients with measurable disease must have had at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy * Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl * This ANC cannot have been induced or supported by granulocyte colony-stimulating factors * Platelets greater than or equal to 100,000/mcl * Creatinine =< 1.5 times institutional upper limit of normal (ULN) * Bilirubin < 1.2 times ULN * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3.0 times ULN * Alkaline phosphatase =< 2.5 times ULN * Left ventricular ejection fraction (LVEF) greater than or equal to institutional lower limit of normal (LLN) as determined by gated cardiac radionucleotide scan (MUGA) or echocardiogram * Neuropathy (sensory and motor) less than or equal to grade 1 * Patients must have a platinum-free interval following initial platinum-based chemotherapy of at least 6 months at first recurrence; front-line therapy may have included a biologic/targeted agent (e.g., bevacizumab) * NOTE: Front-line treatment may have included maintenance therapy; patients receiving maintenance therapy (biological therapy, hormonal, or taxane therapy) are ELIGIBLE provided their platinum-free interval is at least 6 months from initial chemotherapy AND a minimum of 4 weeks has elapsed since their last dose of biologic/targeted or taxane therapy or a minimum of 1 week has elapsed since their last dose of hormonal therapy * Patients must have a Gynecologic Oncology Group (GOG) performance status of 0 or 1 * Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; if applicable, patients must discontinue breastfeeding prior to study entry * Patients who have met the pre-entry requirements * Patients must have signed an Institutional Review Board (IRB)-approved informed consent and authorization permitting release of personal health information * ADDITIONAL CRITERIA FOR PATIENTS BEING TREATED ON BEVACIZUMAB COHORT * Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 X ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) < 1.5 X ULN * Urine protein should be screened by urine analysis; if protein is 2+ or higher, 24-hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment * Patients treating with enoxaparin are eligible for inclusion in the study * Fertile women must agree to use adequate contraceptive measures during study therapy and for at least 6 months after the completion of bevacizumab therapy; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating physician immediately Exclusion Criteria: * Patients who have received more than one previous regimen of chemotherapy (maintenance is not considered a second regimen) * Patients who have received prior ABT-888 or any other poly-adenosine diphosphate (ADP)--ribose polymerase (PARP) inhibitor * Patients who have received prior PLD * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 or other agents used in this study * Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy * Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease * Patients who have received prior chemotherapy for any abdominal or pelvic tumor (other than ovarian, fallopian tube and primary peritoneal) are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease * Patients with synchronous primary endometrial cancer or a history of endometrial cancer, unless all of the following conditions are met: * Stage not greater than IB * No more than superficial myometrial invasion * No vascular or lymphatic invasion * No poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions * Patients with known chronic or active hepatitis or ongoing or active infection that requires parenteral antibiotics * Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy * Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant or patients who are breastfeeding are not eligible for this trial * Patients with seizures or a history of seizures are ineligible * Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any CNS metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study; patients with CNS metastases must be stable for > 3 months after treatment and off steroid treatment prior to study enrollment * Patients who cannot swallow pills * ADDITIONAL CRITERIA FOR PATIENTS BEING TREATED ON BEVACIZUMAB COHORT: * History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab * Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with bevacizumab * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible * Urine protein should be screened by urine analysis; if protein is 2 + or higher, 24-hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment * Serious non-healing wound, ulcer, or bone fracture * History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months to day 1 * Invasive procedures defined as follows: * Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 therapy * Anticipation of need for major surgical procedures during the course of the study * Core biopsy within 7 days prior to day 1 (D1) therapy * Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to day 1 * Known CNS disease except for treated brain metastases; treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 3 months, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT]); (stable dose of anticonvulsants are allowed); treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded * Patients with clinically significant cardiovascular disease are excluded * Inadequately controlled hypertension (HTN) (systolic blood pressure [SBP] > 160 mm Hg and/or diastolic blood pressure [DBP] > 90 mm Hg despite antihypertensive medication) * History of cerebrovascular accident (CVA) within 6 months * History of myocardial infraction or unstable angina within 6 months * New York Heart Association grade II or greater congestive heart failure * Serious and inadequately controlled cardiac arrhythmia * Significant vascular disease (e.g. aortic aneurysm, history of aortic dissection) * Clinically significant peripheral vascular disease * Evidence of bleeding diathesis or coagulopathy * Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies

Study Objectives The primary purpose of this study is to evaluate the safety, toxicities, dosage and response rate for an investigational drug, motexafin gadolinium, administered to patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The secondary purpose of this study is to evaluate the clinical benefit rate, the time it takes for a patient's chronic lymphocytic leukemia or small lymphocytic lymphoma to worsen, the duration of response and the time during which patients survive without chronic lymphocytic leukemia or small lymphocytic lymphoma worsening. Additionally, the patient's response to motexafin gadolinium will be compared to the response of the patient's cells in a laboratory to motexafin gadolinium. Conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Leukemia, Lymphoma Intervention / Treatment: DRUG: motexafin gadolinium Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * >= 18 years old * CLL as defined by the NCI 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t[11;14] translocation or cyclin D1) or SLL as defined by WHO classification criteria and is refractory or relapsed as defined by one of the following: * Refractory disease: progressive disease while on therapy * Relapsed disease: progressive disease after at least one treatment course of therapy with disease response or stabilization * ECOG performance status score of 0, 1, or 2 * Willing and able to provide written informed consent Exclusion Criteria: * Laboratory values of: * Platelet count < 30,000/µL * AST or ALT > 2 x ULN (upper limit of normal) * Total bilirubin > 2 x ULN * Creatinine > 2 mg/dL * Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment * Major surgery or hospitalization for a serious illness within the last 3 months * Greater than three prior regimens (where a regimen is defined as a treatment for CLL/SLL given initially or after disease progression) * Prior malignancy requiring current or prior treatment within the past 5 years, except for cervical neoplasia in situ and non-melanomatous skin cancer * Uncontrolled hypertension

Study Objectives This study compares capecitabine with standard 5-FU in the perioperative treatment of locally advanced rectal cancer. Conditions: Rectal Cancer Intervention / Treatment: DRUG: Capecitabine, DRUG: 5-FU Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Eligible patients are >= 18 years and have histologically confirmed adenocarcinoma of the rectum (defined as the distal border of the tumour less than 16 cm from the anal verge measured by rigid rectoscopy) with no evidence of distant metastases (identified by abdominal ultrasound or CT scan and chest radiography). * Patients in the adjuvant cohort have undergone R0-resection by total mesorectal excision (TME) of a pT3-4 N any or T any N positive non-metastatic rectal cancer. * Patients treated in the neoadjuvant cohort need to have a clinical T3-4 N any or T any N positive tumour staged by endoscopic ultrasound, provided the lower border of the tumour is located 0 - 16 cm from the anal verge measured by rigid rectoscopy and the primary tumour is deemed resectable by TME surgery on the basis of clinical assessment. Other eligibility criteria comprise: WHO status of zero or one; adequate liver, renal, and bone marrow function defined as follows: leucocyte count > 3,500/µl, thrombocyte count > 100,000/µl, hemoglobin > 10.0 g/dl; serum bilirubin < 2.0 mg/dl, serum creatinine < 2.0 mg/dl. Exclusion criteria: * Prior treatment for rectal cancer, prior chemo- or immunotherapy, prior pelvic radiotherapy, or a history of other malignant diseases within the past five years with the exception of successfully treated basal carcinoma of the skin or carcinoma in situ of the uterine cervix. * Participation in another trial, pregnancy, breast-feeding, unwillingness to use effective contraception, or a medical condition or concomitant illness which could potentially interfere with compliance to the protocol are regarded as exclusion criteria, as well.

Study Objectives The patients enrolled on this new study will serve as an appropriate comparison group consisting of patients with the diagnosis of germ cell testicular cancer who were cured with surgical resection and did not receive cisplatin-based chemotherapy with a group of patients from another study who did receive cisplatin-based chemotherapy. Conditions: Testicular Neoplasms Intervention / Treatment: BEHAVIORAL: Questionnaire Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Diagnosis or confirmation of diagnosis of a histologically or serologically confirmed testicular germ cell tumor (GCT) or GCT at another anatomic location * Age at GCT diagnosis: 55 years of age or younger * Males, 18 years of age or older at time of study consent * Subject is able to provide consent * Subject is able to speak and read English * Treatment consisted of surgery only (i.e., orchiectomy and/or retroperitoneal lymph node dissection [RPLND]) for either initial testicular germ cell tumor (GCT) or subsequent testicular cancer * Subject completed surgery > 1 year ago * Subject is currently undergoing active follow-up at IU * Subject did not require any subsequent chemotherapy, salvage chemotherapy treatment or bone marrow transplant. * Subject had no prior chemotherapy of any kind Exclusion Criteria: * Patients with prior chemotherapy (whether for GCT or any other cancer)

Study Objectives NOTE: This study is now recruiting only patients with Myeloproliferative Neoplasms (MPN). Dose escalation has been completed. The purpose of this study is to test a new drug, called PU-H71 for the first time in humans, to find out what effects, good or bad, this new drug has on the patient and the cancer at different dose levels. PU-H71 blocks a protein called Heat Shock Protein-90 (Hsp90). Hsp90 is found in both normal and cancer cells, but may be more important in cancer cells. Attacking Hsp90 can stop the function of certain proteins that are needed for cancer cells to survive. The diseases that are part of this study may be especially sensitive to attacking Hsp90, and the investigators have seen signs of disease control in patients with MPN. This study is currently enrolling a cohort expansion for patients with myeloproliferative neoplasms (MPN). Conditions: Metastatic Solid Tumor, Lymphoma, Myeloproliferative Neoplasms (MPN) Intervention / Treatment: DRUG: PU-H71 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The safety-expansion phase will be open to accrual only for patients with MPN. * >= 18 years of age * For patients with solid malignancies and lymphoma, radiographically detectable (Either FDG-PET, CT scan/ MRI or Bone Scan) or measurable disease will be required. Measurable disease is defined as at least one measurable lesion >= 10 mm on CT scan (15 mm for nodal lesions). * Prior therapy for advanced malignancy with no current curative option * Neutrophil count >= 1,000/μL, platelet count >= 50,000/μL, and hemoglobin >= 8 g/dL (Platelet count must be assessed at least 7 days after a prior transfusion, if any) * Serum bilirubin <= 1.5 mg/dL; * AST and ALT<= 1.5 × ULN * Serum creatinine <= 1.5 mg/dL or creatinine clearance of >= 50 mL/min based on a 24-hour urine collection * Patients receiving hydroxyurea may continue receiving it for up to 14 days after the start of protocol treatment if WBC >30 x10^9/L. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Patients with HIV/AIDS are allowed on study if they have an undetectable viral load, CD4 > 300 and on stable Highly Active Antiretroviral Therapy (HAART) regimen for 1 month. * Patients who have been treated for at least two weeks with stable doses of corticosteroids to address conditions unrelated to their malignancy will be allowed to continue this treatment during enrollment on the current trial. * Patients currently being treated with a gonadotropin-releasing hormone agonist (GnRH agonist), bicalutamide or with bisphosphonates may continue treatment while on clinical trial PU-H71 as long as the treatment has been initiated before the study start. GnRH agonist must have been well tolerated for at least three months. * Optional participation in the microdose imaging trial, IRB#10-139. * Signed written informed consent and HIPAA consent. * PATIENTS WITH MPN must be: * On ruxolitinib for at least three months and on a stable dose for at least 1 month prior to enrollment and taking at least 5 mg twice daily of ruxolitinib * Tolerating ruxolitinib but with persistent manifestations of disease (i.e. persistent splenomegaly, abnormal blood counts, persistent constitutional symptoms residual fibrosis in bone marrow (2+ or greater), or measurable allele burden as evidenced of clonal JAK2 or MPL mutation). * Ruxilitinib treatment requirements will be waived for patients who have failed this treatment in the past or for whom this treatment is otherwise contraindicated EXCLUSION CRITERIA * Ejection fraction < 50%, as determined by echocardiogram or MUGA scan * Symptomatic brain or CNS metastases. Previously treated and stable CNS disease is allowed. * Any of the following for the treatment of cancer within 2 weeks of first study treatment: chemotherapy, immunotherapy, experimental therapy or biologic therapy. * Any major surgical procedure or radiation within 4 weeks of first study treatment * Active liver disease, including viral or other hepatitis, or cirrhosis * Pregnancy or lactation * Active hepatitis or other active infections * Any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months. * Patients with a permanent pacemaker * Patients with a QTcF or QTcB > 480 ms in the baseline EKG * Systemic corticosteroids (e.g. prednisone >= 12.5 mg/day or dexamethasone >= 2 mg/day) for the purpose of palliating tumor-related symptoms will not be allowed within 1 week of starting treatment on trial.

Study Objectives This study was designed to provide all adult and pediatric arthritis patients (placebo and etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The primary objective of this study is to examine safety parameters. Conditions: Rheumatoid Arthritis Intervention / Treatment: BIOLOGICAL: Etanercept Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Previous enrollment in Immunex protocols * No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment. * Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential. * No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc). Exclusion Criteria: - Previous receipt of TNFR:Fc (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein. * Receipt of investigational drugs or biologics (other than TNFR:Fc [p75]) within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study. * Receipt of DMARDs or methotrexate (except patients from 16.0014) within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study. * Receipt of cyclophosphamide within six months prior to the first dose of (etanercept (TNFR:Fc) in this study. * Receipt of cyclosporin within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.

Study Objectives This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) to guide late-line therapy in late-stage metastatic breast cancer patients. Conditions: Metastatic Breast Cancer, Circulating Tumor DNA, Gene Abnormality Intervention / Treatment: DRUG: Control group, DRUG: Case group Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Recent progression of TNBC after multiple lines of chemotherapy or of HR+ or HER2+ MBC after multiple lines of endocrine or targeted therapy; * No available recommendation for the next treatment regimen; * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; * An updated, available pathological HR/HER2 status for metastasis; * According to RECIST 1.1 standard, there should be at least one measurable target lesion; * The expected survival time is > 3 months; * Those aged 18-70 years old; * Liver and kidney function and blood routine test meet the following conditions: Neutrophil > 2.0g/l, Hb > 9g / L, PLT > 100g / L; ALT and AST < 2.5ULN; TBIL < 1.5ULN; Cr < 1.0ULN * Signing informed consent; * Those willing to accept polygenic testing. Exclusion Criteria: * Patients with multiple primary tumors; * Those who are unable to obtain blood samples; * Those with a history of immunodeficiency or organ transplantation; * Those with abnormal cardiac function or previous history of myocardial infarction or serious arrhythmia; * The researchers think it is not suitable to participate in this experiment.

Study Objectives This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI). This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall response rate in each arm at regular intervals over a maximum of 60 months follow-up. Conditions: Cancer, Colon Cancer, Colorectal Cancer, Fever, Locally Advanced, Metastatic Colorectal Cancer, Neutropenia, Rectal Cancer Intervention / Treatment: DRUG: Pegfilgrastim, DRUG: Placebo, BIOLOGICAL: Bevacizumab, DRUG: Standard Chemotherapy Location: Bulgaria, Hungary, Mexico, Canada, Italy, Ukraine, Romania, United States, Belgium, Australia, Slovakia, Ireland, Czechia, Latvia, Russian Federation, France, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: Disease-related: * Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum * Locally-advanced or metastatic disease by radiographic evaluation * Measurable disease * Has not previously received chemotherapy for locally-advanced or metastatic colorectal cancer. Patient may have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent/metastatic disease was documented. * Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 Demographic: * Age of 18 years or over Laboratory: Adequate organ and marrow function as defined below: * Absolute neutrophil count at least 1.5 x 10^9/L * Platelet count at least 100 x 10^9/L * Bilirubin <= 1.5 times upper limit of normal * Aspartate aminotransferase and alanine aminotransferase <= 2.5 x upper limit of normal or Aspartate aminotransferase and alanine aminotransferase <= 5.0 x upper limit of normal if attributable to liver metastasis * An in-range international normalized ratio (INR) (in-range is usually defined as between 2 and 3) for patients on a stable dose of oral anticoagulant or stable dose of low molecular weight heparin * Has no active bleeding or pathological condition that carries high risk of bleeding (eg, tumor involving major vessels or known varices). If a suspicion of bleeding diathesis exists, a bleeding time should be performed * Creatinine <= 1.5 times upper limit of normal General: * Written informed consent obtained * Afebrile on day 1 of cycle 1 * Must be able and willing to comply with study and/or follow-up procedures Exclusion Criteria: Disease-Related: * Known brain metastases * History of another primary malignancy less than/equal to 5 years prior to randomization, with the exception of non-melanoma skin cancer, carcinoma in situ of uterine cervix, and prostatic intraepithelial neoplasia without evidence of prostate cancer * Prior major surgical procedure less than 28 days prior to day 1 of cycle 1 chemotherapy dosing; anticipated need for major surgical procedure during the 4 cycle treatment period of the study * Fine needle aspirations or core biopsies within 7 days prior to day 1 of cycle 1 chemotherapy dosing * Serious nonhealing wound, ulcer, or bone fracture, or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1 of cycle 1 * Uncontrolled high blood pressure, history of labile hypertension, uncontrolled congestive heart failure, unstable angina within the past 3 months, myocardial infarction or history of stroke within the past 12 months, unstable symptomatic arrhythmia requiring medication, or clinically significant peripheral vascular disease * History of clinically significant bleeding within 6 months prior to randomization * History of arterial or venous thromboembolism within 6 months prior to randomization * History of other disease including uncontrolled diabetes, serious active or uncontrolled infection, metabolic dysfunction; physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the prescribed therapy or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications Laboratory: * Proteinuria > 1+, or total quantitative protein > 500 mg protein/day as determined by 24-hr urine collection Medications: * Prior radiotherapy unless treatment was limited to the target lesion and only 1 measurable lesion was treated. Progression of the irradiated lesion must be demonstrated. Patients may not have received prior radiotherapy to greater than 25% of bone marrow. Radiation must have concluded >= 4 weeks prior to enrollment. Prior radio-sensitizing chemoradiation will be allowed as long as it was concluded >= 4 weeks prior to enrollment. * Radiotherapy to non-target lesions for pain control will be allowed * Prior bevacizumab use or other agents targeting VEGF * Concurrent use of other biological agents * Use of systemic anti-infectives for active infection, during the 3 calendar days before starting study chemotherapy and bevacizumab or planned during the study treatment period General: * Current, recent (within 4 weeks of the first infusion of this study), or planned participation (during the study treatment period) in an experimental therapeutics study other than this protocol * Female participants who are pregnant or lactating or men and women of reproductive potential not willing to employ an effective method of birth control during treatment and for 20 weeks for women, and 30 weeks for men after discontinuing study treatment * History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab, irinotecan, 5-fluorouracil (5-FU), oxaliplatin, or leucovorin, including known sensitivity to E. Coli derived products (eg, Filgrastim, HUMULIN insulin, L-asparaginase) * Known dihydropyrimidine dehydrogenase deficiency

Study Objectives This phase I/II trial studies the side effects and best dose of carmustine when given together with O6-benzylguanine and to see how well they work in treating patients with stage IA-IIA cutaneous T-cell lymphoma. Drugs used in chemotherapy, such as carmustine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. O6-benzylguanine may help carmustine work better by making cancer cells more sensitive to the drug. Giving O6-benzylguanine with carmustine may kill more cancer cells. Conditions: Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Stage I Mycosis Fungoides and Sezary Syndrome AJCC v7, Stage II Mycosis Fungoides and Sezary Syndrome AJCC v7 Intervention / Treatment: DRUG: Carmustine, OTHER: Laboratory Biomarker Analysis, DRUG: O6-Benzylguanine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosis of CTCL stages IA-IIA by histopathology and immunohistochemistry in screening biopsies confirmed at Case Western Reserve University within 6 months of enrollment; biopsies may be performed at the site of collaborating institutions and shipped to University Hospitals of Cleveland-Case Western Reserve University (UHC-CWRU) * Performance status Eastern Cooperative Oncology Group (ECOG) grade 0, 1, or 2 * Patients must have recovered from toxicity of prior treatment and have received no CTCL therapy other than emollition for at least 4 weeks, with the exception of topical corticosteroids, which may be used up to 2 weeks before the trial start date * Patients must have signed a consent form indicating the investigational nature of the treatment and its potential side effects * White blood cell (WBC) at least 3.5 x10E9/L * Absolute neutrophil count (ANC) at least 1.6 x10E9/L * Platelets > 100,000/ul * Bilirubin < 1.5 mg/dL * Serum glutamic oxaloacetic transaminase (SGOT) within normal range * Creatinine =< 1.5 mg/dL * Electrolytes normal * Controlled (diet and insulin) diabetes is permitted * Demonstration of clinically normal lung function based on history and physical examination; patients with clinical evidence of pulmonary disease as determined by the investigator should have baseline lung function tests performed with demonstration of diffusing capacity of the lung for carbon monoxide (DLCO) >= 70%; a DLCO single breath, adjusted for hemoglobin, will be utilized; we will not use DLCO/alveolar volume (VA) for inclusion or exclusion in this study * Patients must have cutaneous disease that is amenable to biopsy and must be willing to undergo several sequential biopsies * Must have failed at least one conventional treatment for CTCL other than topical corticosteroids; this includes phototherapy, topical mechlorethamine, topical or oral bexarotene, radiation therapy, photopheresis, chemotherapy, and immunomodulatory agents such as interferon and other retinoids Exclusion Criteria: * Patients who have received prior treatment with topical or systemic BCNU or other nitrosoureas * Patients with known central nervous system involvement or primary central nervous system (CNS) malignancies * Patients with performance status ECOG grade 3 or 4 * Pregnant women, women who are breast feeding infants, or women with reproductive potential not practicing adequate contraception * Patients with an active infection which requires hospitalization, or which may affect the patient?s safety if the patient was enrolled * Patients with pulmonary disease as determined by history, physical examination, chest X-ray, or pulse oximetry with < 70% predicted DLCO * CTCL patients with stage IIB-IVB disease

Study Objectives FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in participants with advanced solid tumors. Conditions: Advanced Solid Tumors, Lymphoma, Gastric Cancer, Colorectal Cancer, Head and Neck Cancer, Squamous Cell Carcinoma, EGFR Positive Solid Tumor, HER2-positive Breast Cancer, Hepatocellular Carcinoma, Small Cell Lung Cancer, Renal Cell Carcinoma, Pancreas Cancer, Melanoma, NSCLC, Urothelial Carcinoma, Cervical Cancer, Microsatellite Instability, Merkel Cell Carcinoma Intervention / Treatment: DRUG: FT500, DRUG: Nivolumab, DRUG: Pembrolizumab, DRUG: Atezolizumab, DRUG: Cyclophosphamide, DRUG: Fludarabine, DRUG: IL-2 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Diagnosis of the following, as per Regimen Cohort: 1A. Regimen A: FT500 Monotherapy (Dose Escalation): An advanced solid tumor malignancy, including lymphoma, in a participant who has failed or refused available FDA-approved therapies and is now a candidate for salvage therapy. 1B. Regimen B and BB (Dose Escalation): FT500 (+ IL-2, Regimen BB only) + ICI: An advanced solid tumor malignancy, including lymphomas, that has progressed on treatment with at least one ICI (ie, nivolumab, pembrolizumab or atezolizumab), in a participant who has also failed or refused other available approved therapies and is now a candidate for salvage therapy. 1C. Regimen B(Dose Expansion): FT500 (+ IL-2, Regimen BB only) + ICI An advanced solid tumor malignancy or lymphoma in a participant with disease relapse or progression on an ICI (nivolumab, pembrolizumab, or atezolizumab) in an approved indication per the respective USPI. * Willingness to provide informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Age >18 years old at the time of signing the ICF. 4. Presence of measurable disease by iRECIST or RECIL criteria, assessed before the start of lympho-conditioning and within 28 days prior to Day 1. * Contraceptive use by women or men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 5a. Female participants: Women of childbearing potential (WOCBP) must use a highly effective form of contraception from the screening visit until at least 12 months after the final dose of CY, at least 4 months after the final dose of FT500, at least 4 months after the final dose of pembrolizumab, and at least 5 months after the final dose of nivolumab or atezolizumab, whichever is latest. 5b. Male participants: Males must be sterile (biologically or surgically) or use a highly effective method of contraception from the screening visit until at least 14 months after the final dose of CY, at least 6 months after the final dose of FT500, at least 6 months after the final dose of pembrolizumab, and at least 7 months after the final dose of nivolumab or atezolizumab, whichever is latest. * Willingness to comply with study procedures through the planned study duration. For patients with >1 measurable lesion, agreement to undergo a biopsy from a safely accessible site per Investigator assessment for exploratory biomarker assessments. * Provision of signed and dated ICF to agree to participate, at time of withdrawal or completion of this study, in Fate Therapeutics' long-term, non-interventional, observational study, FT-003. Exclusion Criteria: All participants: * Females who are pregnant or breastfeeding. 2. ECOG performance status >= 2. 3. Evidence of insufficient organ function as determined by any one of the following: 3a. Neutrophils <1000/µL or platelets <75,000/µL. 3b. Estimated creatinine clearance <50 mL/minute (Cockcroft-gault). 3c. Total bilirubin >2 x upper limit normal (ULN) with the exception of participants with Gilbert's Syndrome or known liver metastases. 3d. Aspartate aminotransferase (AST) >3 x ULN, or alanine aminotransferase (ALT) >3 x ULN. For participants with known liver metastases, AST or ALT >5 x ULN. 3e. Oxygen saturation <90% on room air. 3f. Left ventricular ejection fraction (LVEF) <40% (eg by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan). *Receipt of any biological therapy, chemotherapy, or radiation (except palliative radiation) within 2 weeks prior to Day 1. Participants in Regimen B currently taking an ICI must interrupt ICI dosing at least 2 weeks prior to Day 1. * CNS metastases that have not been treated; or treated CNS metastases that have not been stable for at least 4 weeks. * Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months prior to first study medication; or the presence of unstable angina or congestive heart failure of New York Heart Association grade 2 or higher. * Currently receiving or likely to require systemic immunosuppressive therapy (eg, prednisone >5 mg daily) for any reason from Day -7 to Day 29. * Uncontrolled infections. 9. Known allergy to the following FT500 components: Albumin (Human) or DMSO. 10. Presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to participant. * Any medical condition or clinical laboratory abnormality that, per Investigator or Medical Monitor judgement, precludes safe participation in and completion of the study, or that could affect compliance with protocol conduct or interpretation of results. Participants who have had prior receipt of a Fate Therapeutics investigational human iPSC product may be eligible for the study with approval from the Medical Monitor. Additional Exclusion Criteria for Regimen B: FT500 + ICI: * Participants who experienced an ICI-related adverse reaction that resulted in discontinuation of the ICI. * Presence or history of autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma, Crohn's disease, ulcerative colitis), except for participants with isolated vitiligo, atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and controlled thyroid disease. * Participants who have received an allograft organ transplant.

Study Objectives This is a single-arm phase II study of continuation immunotherapy with pembrolizumab following initial benefit (CR, PR, or SD ≥ 3 months) with a PD-1 or PD-L1 inhibitor. Conditions: Non-Small-Cell Lung Cancer Intervention / Treatment: DRUG: Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Subjects must meet all of the following applicable inclusion criteria to participate in this study: * Written informed consent and HIPAA authorization for release of protected health information. * Age >= 18 years at the time of consent. * Histological or cytological evidence of stage IV NSCLC (any histology) * Subjects must have progressed on or after previous platinum-based chemotherapy. Chemotherapy may have previously been given with a PD-1 or PD-L1 inhibitor. Subjects must have also progressed on or after receiving any PD-1 or PD-L1 inhibitor (including pembrolizumab) as their most recent therapy and must have had at least a 3-month PFS on this therapy. * Subjects must be enrolled on the trial within 6 weeks of their last infusion of PD-1 or PD-L1 inhibitor therapy. * Subjects whose tumors harbor a mutation in EGFR exon 19 or 21 or have gene rearrangements in ALK or ROS1 must have already been treated with standard targeted therapies. NOTE: Subjects must also have progressed on or after platinum-containing combination chemotherapy. * ECOG Performance Status of 0 or 1 within 28 days prior to registration for protocol therapy. * Must be fit enough to receive next-line chemotherapy (either gemcitabine, docetaxel, or pemetrexed [non-squamous only]) according to the discretion of the treating physician. * Adequate laboratory values obtained within 28 days prior to registration for protocol therapy. * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to study registration and/or within 72 hours of first dose of study drugs. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Women of childbearing potential must be willing to use two methods of contraception or abstain from heterosexual activity from the point of registration through 120 days after the last dose of study drug. * Male subjects capable of fathering a child must agree to use an adequate method of contraception starting with the first dose of the study drug through 120 days after the last dose of the study drug. Exclusion Criteria: Subjects meeting any of the criteria below may not participate in the study: * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Active central nervous system (CNS) metastases. NOTE: Subjects who are symptomatic or have not undergone prior brain imaging must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to registration to exclude brain metastases. * Treatment with any investigational agent within 28 days prior to registration for protocol therapy with the exception of PD-1 or PD-L1 inhibitors. * No active second cancers with the exception of localized non-melanoma skin cancer, in-situ cervical or in-situ bladder cancer. * Evidence of active autoimmune disease requiring systemic treatment within the past 90 days or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. * History of (non-infectious) pneumonitis requiring treatment with corticosteroids, evidence of interstitial lung disease or active, non-infectious pneumonitis. * History of an immune-related toxicity requiring treatment with corticosteroids during prior PD-1/ PD-L1 inhibitor treatment. * Diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy or other immunosuppressive therapy (excludes inhaled corticosteroids) within 7 days of study registration. * History of psychiatric illness or social situations that would limit compliance with study requirements. * Clinically active infection (>= Grade 2) as judged by the site investigator. * Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. NOTE: HIV, HBV or HCV testing is not required. * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the site investigator. * Known history of active TB (Bacillus Tuberculosis). * History of hypersensitivity to pembrolizumab, docetaxel, gemcitabine, pemetrexed or any of their excipients. * Has received a live vaccine within 30 days prior to planned start of study therapy.

Study Objectives RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the drug's toxicity is manageable. PURPOSE: This phase II trial is studying how well famitinib works in treating patients with recurrent and/or metastatic NPC. Conditions: Recurrent Nasopharyngeal Carcinoma, Metastatic Nasopharyngeal Carcinoma Intervention / Treatment: DRUG: Famitinib Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologic confirmed recurrent and/or metastatic nasopharyngeal carcinoma( NPC ) * Have failed for >=2 lines of chemotherapy * At least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer <= 5 mm ) * >= 18 and <= 70 years of age * ECOG performance scale 0-2 * Life expectancy of more than 3 months * More than 4 weeks after operation, chemotherapy, radiotherapy, cytotoxic agents or tyrosine kinase inhibitors * Adequate hepatic, renal, heart, and hematologic functions (hemoglobin >= 90g/L, platelets >= 80×10^9/L, neutrophils >= 1.5×10^9/L, 24-hour urinary protein <= 1.0 g total bilirubin < 1.25×the upper limit of normal(ULN), and serum transaminase < 1.5×the ULN (If liver metastases, serum transaminase< 2.5×the ULN), serum creatine <= 1x ULN, creatinine clearance rate > 50ml/min, Cholesterol<=7.75 mmol/L and triglyceride<=2.5 x ULN, LVEF: >= 50% * Patients could provide 4-6 pieces of organization wax or pathological section * Female: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. Child bearing potential, a negative urine or serum pregnancy test result before initiating Famitinib. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. * Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure. Exclusion Criteria: * Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR, PDGFR and c-Kit * Prior radiotherapy more than 2 courses * Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Less than 4 weeks from the last clinical trial * Any factors that influence the usage of oral administration * Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening * Imageology shows that tumor lesion less than 5 mm to great vessels * Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy, more than cla ss I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia, or cardiac insufficiency * URT: urine protein >= ++ and > 1.0 g of 24 h * Long-term untreated wounds or fractures * Blood coagulation abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation. * Within 6 months before the first treatment occurrs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc. * Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; If the prothrombin time international normalized ratio (INR) <= 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) or low-dose aspirin (between 80mg to 100mg daily) is allowed * Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range * Abuse of Psychiatric drugs or dysphrenia * Viral hepatitis type B or type C * Immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation * Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Study Objectives This pilot clinical trial studies the side effects of lenalidomide and ipilimumab after stem cell transplant in treating patients with hematologic or lymphoid malignancies. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide with ipilimumab may be a better treatment for hematologic or lymphoid malignancies. Conditions: B-Cell Non-Hodgkin Lymphoma, Hematopoietic and Lymphoid Cell Neoplasm, Leukemia, Lymphoma, Plasma Cell Myeloma, T-Cell Non-Hodgkin Lymphoma Intervention / Treatment: BIOLOGICAL: Ipilimumab, DRUG: Lenalidomide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Hematologic or lymphoid malignancy * Autologous patients can be included anytime within 6 months post-transplant, if they had no signs of progression and meet one of the following criteria: i. leukemia; ii. lymphoma (all types of B and T cell lymphoma); iii. multiple myeloma * Allogeneic patients if: i. patients had engrafted donor cells (i.e., > 20% donor T-cell from peripheral blood [PB]/polymerase chain reaction [PCR]); and, ii. patients NOT in complete remission (CR) after their allogeneic transplant, and off tacrolimus and/or mycophenolate mofetil for at least 3 to 4 weeks with no signs of GVHD; or, iii. patients had evidence of relapse after their transplant who are off tacrolimus and/or mycophenolate mofetil or other immunosuppressants for GVHD for 3 to 4 weeks with no signs of GVHD (prednisone doses =< 10 mg are permitted as stated previously) * No active infection * Absolute neutrophil count (ANC) >= 1.5 x 10^9/L * Platelets > 75 x 10^9/L * Able to adhere to the study visit schedule and other protocol requirements * Performance status: Eastern Cooperative Oncology Group (ECOG) 2 or less or Karnofsky of at least 60 * Cardiac ejection fraction (EF) >= 45% by 2-dimensional echocardiogram (2D-ECHO) within 3 months of study entry (or within 1 month if received chemotherapy within the past 3 months) * Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO) >= 40% within 3 months of study entry (or within 1 month if received chemotherapy within the past 3 months) * Serum creatinine =< 1.6 mg/dL and creatinine clearance >= 30 ml/min; creatinine clearance will be calculated using the Cockcroft-Gault equation * Serum glutamate pyruvate transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT) less than 2 x the upper limit of normal range (unless related to Gilbert's disease or medications) * Direct bilirubin < 1.6 (unless related to Gilbert's disease or medications) * Patient or legally authorized representative able to sign informed consent * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to study entry Exclusion Criteria: * Immunotherapy or chemotherapy with approved or investigational anticancer therapeutics within 4 weeks of first dose * Patients on alemtuzumab within 6 weeks prior to consenting * Active congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic ischemia or conduction abnormalities uncontrolled by conventional interventions; myocardial infarction within 6 months of study entry * Deep vein thrombosis or pulmonary embolism within 3 months of study entry * Pregnant or breast-feeding females; (lactating females must agree not to breast-feed while taking lenalidomide) * Acute active infection requiring intravenous antibiotics, antiviral (except antiviral directed at hepatitis B), or antifungal agents within 14 days of first dose * Known human immunodeficiency virus (HIV) seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen [Sag] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed) * Patients with other known malignancies within the past three years except: i. adequately treated basal or squamous cell skin cancer; ii. carcinoma in situ of the cervix; iii. prostate cancer with Gleason score < 6 with stable prostate-specific antigen (PSA) over the past three months; iv. breast cancer in situ with full surgical resection * Significant neuropathy (grades 3 to 4 or grade 2 pain) * Known hypersensitivity to thalidomide, lenalidomide or ipilimumab * Active life-threatening autoimmune disease * Active GVHD or recent GVHD and still on > 10 mg prednisone (or equivalent) * Prior auto-immune disease

Study Objectives This phase II trial studies how well alisertib works in treating patients with leiomyosarcoma of the uterus that has come back or persistent. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Recurrent Uterine Corpus Sarcoma, Uterine Corpus Leiomyosarcoma Intervention / Treatment: DRUG: Alisertib, OTHER: Laboratory Biomarker Analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have incurable recurrent or persistent uterine leiomyosarcoma; histologic confirmation of the original primary tumor is required * Patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI * Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST version 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy * Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol for the same patient population (12/10/2012) * Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2; patients who have received two prior regimens must have a GOG performance status of 0 or 1 * Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI]) * Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration * Any other prior therapy directed at the malignant tumor, including chemotherapy and immunologic agents, must be discontinued at least three weeks prior to registration (12/10/2012) * Any prior radiation therapy must be discontinued at least four weeks prior to registration (12/10/2012) * Patients must have had at least one prior chemotherapeutic regimen for management of leiomyosarcoma * Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease (12/10/2012) * Patients must NOT have received any prior therapy directed at Aurora kinase for management of recurrent or persistent disease; patients who were treated on GOG-0250 (gemcitabine + docetaxel plus bevacizumab vs placebo) are eligible; treatment on GOG-0250 would count as ONE prior regimen * Leukocytes >= 3,000/mcL * Absolute neutrophil count >= 1,500/mcL * Platelets >= 100,000/mcL * Serum creatinine =< institutional upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min/1.73m^2 (calculated or measured) * Bilirubin =< ULN * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x ULN * Alkaline phosphatase =< 2.5 x ULN * Patients must have signed an approved informed consent and authorization permitting release of personal health information * Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception; pregnant women are excluded from this study * Patients must be able to take oral medication and to maintain a fast for 2 hours before and 1 hour after MLN8237 administration * Patient must not have taken agents that effect gastric pH within 4 days (any proton pump inhibitor), or 1 day (any histamine-2 antagonist) of the planned start of therapy; patients must be able to avoid all other types of antacids for 2 hours before and 2 hours after each dose of MLN8237 Exclusion Criteria: * Patients who have had prior therapy with MLN8237 or taken part in a study of an investigational compound or device within 4 weeks of entering this study * Patients who have had surgery (excluding biopsy), radiotherapy, or chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the planned start of protocol treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have had hormonal agents within 1 week of the planned start of protocol treatment * Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast, are excluded if there is any evidence of other malignancy being present within the last three years * Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of uterine leiomyosarcoma within the last three years are excluded; thus, patients with a history of prior pelvic radiation for uterine leiomyosarcoma are eligible; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease * Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of uterine leiomyosarcoma within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease * Patients who are nursing because there is an unknown but potential risk for adverse events in nursing infants from MLN8237 * Patients with a history of central nervous system metastases and/or carcinomatous meningitis * Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN8237, including but not limited to established allergic reaction to benzodiazepines * Patients who are known to be human immunodeficiency virus (HIV) positive * Patients who have had prior allogeneic bone marrow or organ transplantation * Patients with a known history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease; requirement for supplemental oxygen; or any conditions that could result in excessive toxicity associated with the benzodiazepine-like effects of MLN8237 * Patients who require constant administration of proton pump inhibitor, H2 antagonist, or pancreatic enzymes; intermittent uses of antacids or H2 antagonists are allowed * Patients who are unable to swallow oral medication or to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration or any condition that would modify small bowel absorption of oral medications, including malabsorption, or resection of pancreas or upper bowel * Patients who have had treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, oxcarbazepine, primidone or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days prior to the first dose of MLN8237 and during the study * Patients who have had a myocardial infarction within 6 months prior to enrollment or have New York Heart Association (NYHA) class III (marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea) or IV (unable to carry out any physical activity without discomfort, symptoms of cardiac insufficiency at rest, if any physical activity is undertaken, discomfort is increased) heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant * Patients must limit alcohol consumption to no more than 1 standard unit of alcohol (12 oz beer [350 mL], 1.5 oz [45 mL] of 80-proof alcohol, or one 6-oz [175 mL] glass of wine) per day during the study and for 30 days from the last dose of MLN8237; patients who are unable to comply with these restrictions are not eligible

Study Objectives The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC). Conditions: Non-small Cell Lung Cancer Intervention / Treatment: DRUG: Aprepitant Location: Japan Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients who receive the combination chemotherapy of nedaplatin and docetaxel as a treatment or an adjuvant therapy for non-small cell lung cancer. * ECOG performance status 0-1. * Aged 20-79 years old. * Laboratory values as follows 4000/mm3 < WBC < 12000/mm3, neutrophil count > 2000/mm3, platelet count > 100000/mm3, hemoglobin > 9.5g/dL, asparate transaminase < 2.5 X cutoff value, alanine transaminase < 2.5 X cutoff value, total bilirubin < 1.5g/dL, Serum creatinine < cutoff value, PaO2 > 60 Torr. * Able and willing to give valid written informed consent. Exclusion Criteria: * Allergy against polysorbert 80 or platinum-containing drugs. * Severe complications (i.e. ischemic heart diseases required treatment, arrhythmia, myocardial infarction within 6 months, liver cirrhosis, uncontrolled diabetes, and hemorrhagic tendency). * Active and uncontrolled infectious disease. * Massive pleural or pericardial effusion. * Other malignancy requiring treatment. * Active interstitial pneumonitis or its past historyBreastfeeding and Pregnancy (woman of child bearing potential) * Peripheral nerve disorder. * Pregnant or lactating women. * Concurrent administration of pimozide. * Decision of unsuitableness by principal investigator or physician-in-charge