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Study Objectives The investigators wish to determine if standard and digital PET/CT scanners provide equivalent results for disease detection and diagnosis. Conditions: Cancer Intervention / Treatment: DIAGNOSTIC_TEST: Digital PET/CT scan Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient is >= 18 years old at the time of the scan * Patient provides written informed consent * Patient is referred for standard (F18 FDG; F18 NaF; Ga68 DOTATATE) or research (68Ga PSMA or 68Ga RM2) PET/CT * Patient is capable of complying with study procedures * Patient is able to remain still for duration of imaging procedure (approximately 60 minutes total for both PET/CT) Exclusion Criteria: * Patient is pregnant or nursing

Study Objectives This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect of T-DM1 on the duration of corrected QT (QTc) interval in patients with HER2-positive locally advanced or metastatic breast cancer and to make preliminary assessments regarding the safety, tolerability, and efficacy of combined T-DM1 and pertuzumab in patients with early disease progression. The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QTcF interval is the QT interval as calculated using Fridericia's correction; the QTcB interval is the QT interval as calculated using Bazett's correction. Conditions: Metastatic Breast Cancer Intervention / Treatment: BIOLOGICAL: pertuzumab, BIOLOGICAL: Trastuzumab emtansine [Kadcyla] Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically documented, locally advanced, or metastatic breast cancer; measurable and/or non-measureable but evaluable disease is permitted * HER2-positive disease * History of prior trastuzumab therapy * Life expectancy >= 90 days as assessed by the investigator * Negative urine pregnancy test <= 72 hours prior to Cycle 1 Day 1 for all women of childbearing potential * For patients of childbearing potential, agreement to use one highly effective form of contraception or two effective forms of contraception for the duration of the study treatment(s) and for 4 months after the last dose of T-DM1 or 6 months after the last dose of pertuzumab, if applicable Exclusion Criteria: * Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 2 weeks of the first study treatment * Prior T-DM1 or pertuzumab therapy * History of intolerance (such as Grade 3-4 infusion reaction) and/or adverse events related to trastuzumab * Grade >= 2 (based on National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v3) peripheral neuropathy at the time of or within 3 weeks prior to the first study treatment * Brain metastases that are untreated or progressive or have required any type of therapy, including radiation, surgery, and/or steroids, to control symptoms from brain metastases within 60 days prior to the first study treatment * History of cardiac disease, unstable angina, symptomatic congestive heart failure (CHF) (Class >= II per the New York Heart Associate [NYHA] guidelines), myocardial infarction, or ventricular arrhythmia <= 6 months prior to Cycle 1, Day 1 * Implantable pacemaker or automatic implantable cardioverter defibrillator * Congenital long QT syndrome or family history of long QT syndrome * Current uncontrolled hypertension * Current treatment with medications that alter cardiac conduction (e.g., digitalis, beta-blockers, or calcium channel blockers) or medications that are generally accepted to have a risk of causing torsades de pointes (TdP) * Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus * Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment, or anticipation of the need for major surgery during the course of study treatment

Study Objectives This current chart review study was designed to investigate the incidence of breast cancer in women treated with subcutaneous testosterone therapy for symptoms of hormone deficiency. Conditions: Breast Cancer Intervention / Treatment: DRUG: Testosterone Implant Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Female patients treated between March 2008 - March 2013 * Women who received at least two testosterone pellet insertion procedures * Women previously accrued to the prospective cohort study Exclusion Criteria: * Pre-existing breast cancer * Women who received a single testosterone pellet insertion

Study Objectives CMP-001-010 is a Phase 2 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) administered to participants with refractory unresectable or metastatic melanoma. The primary objective of the study is to determine confirmed objective response with CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. The secondary objectives are to: * To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. * To evaluate the efficacy of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. * To assess the pharmacokinetic (PK) profile of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. * To assess and describe the immunogenicity of CMP-001 in combination with nivolumab in subjects with refractory unresectable or metastatic melanoma. Conditions: Melanoma, Advanced Melanoma, Metastatic Melanoma, Unresectable Melanoma Intervention / Treatment: DRUG: CMP-001, DRUG: Nivolumab 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 enrolled in the study must meet all of the following inclusion criteria to be eligible. * Histopathologically-confirmed diagnosis of malignant melanoma that is metastatic or unresectable at Screening. * Known BRAF mutation status; if BRAF V600 mutation positive, must have had prior treatment with a local Health Authority approved BRAF inhibitor, with or without mitogen-activated protein kinase inhibitor. Patients with BRAF V600 mutations who refuse a BRAF inhibitor will not be eligible. * Refractory to PD-1 blockade either as monotherapy or in combination with other therapies, as defined by the following criteria: 1. Received treatment with a Food and Drug Administration approved PD-1 blocking antibody for 12 weeks or longer. 2. Have PD (according to RECIST v1.1) within 12 weeks of the last dose of a PD-1 blocking antibody, either as monotherapy or in combination with other agents. Evidence of confirmed PD must be established by investigator assessment at least 4 weeks after the initial date of PD. The second assessment may serve as the Baseline for this study if completed within 30 days before to the start of study treatment. NOTE: in subjects with histologically confirmed recurrence on or after adjuvant PD-1 blocking antibody, confirmatory imaging is not required. * Measurable disease, as defined by RECIST v1.1 and all of the following: 1. At least 1 accessible lesion amenable to repeated IT injection. 2. One or more measurable lesions at least 1 cm in diameter that are not intended for CMP 001 injection and can be followed as target lesions per RECIST v1.1. 3. Documented disease progression in any lesion that was previously radiated in order to serve as a target lesion. * Able to provide tissue from a core or excisional biopsy (fine needle aspirate is not sufficient). A fresh tissue biopsy (within 90 days before the start of study treatment) is preferred but an archival sample is acceptable if no intervening therapy was received. Note: For tissue sampling details, please refer to the laboratory manual. * Adequate organ function based on most recent laboratory values within 3 weeks before first dose of study treatment on Week 1 Day 1 (W1D1): 1. Bone marrow function: * neutrophil count >= 1500/mm3 * platelet count >= 100,000/mm3 * hemoglobin concentration >= 9 g/dL * white blood cells >= 2000/mm3 2. Liver function: * total bilirubin <= 1.5 times the upper limit of normal (ULN) with the following exception: patients with Gilbert Disease total serum bilirubin <= 3 times ULN * aspartate aminotransferase and alanine aminotransferase <= 3 times the ULN 3. Lactate dehydrogenase <= 2 times the ULN 4. Renal function: estimated (Cockcroft-Gault) or measured creatinine clearance >= 30 mL/min. 5. Coagulation: * International normalized ratio or prothrombin time (PT) <= 1.5 times ULN, unless subject is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants * Activated partial thromboplastin time or PTT <= 1.5 times ULN, unless subject is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Age >= 18 years at time of consent. * Eastern Cooperative Oncology Group Performance Status of 0 to 1 at Screening. * Capable of understanding and complying with protocol requirements. * Women of childbearing potential must have negative serum pregnancy test before dosing at W1D1 and be willing to use an adequate method of contraception from the time of consent until at least 150 days after last dose of study treatment. * Able and willing to provide written informed consent and to follow study instructions. Subjects unable to provide written informed consent on their own behalf will not be eligible for the study. Exclusion Criteria: Subjects presenting with any of the following will not qualify for entry into the study: * Uveal, acral, or mucosal melanoma. * Received radiation therapy (or other nonsystemic therapy) within 2 weeks before first dose of study treatment on W1D1. Patients should have recovered (ie, Grade <=1 or at baseline) from radiation-related toxicities. * Treatment with complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before start of study treatment. Refer to Section 4.4. for prohibited therapies. * Received systemic pharmacologic doses of corticosteroids >=10 mg/day prednisone within 30 days before first dose of study treatment on W1D1. 1. Subjects who are currently receiving steroids at a prednisone-equivalent dose of <= 10 mg/day do not need to discontinue steroids before enrollment. 2. Replacement doses, topical, ophthalmologic, and inhalational steroids are permitted. 3. Stress-dose corticosteroids will be required in subjects with adrenal insufficiency * History of immune-related AE that required permanent discontinuation of PD-1 blocking antibody. * Not fully recovered from AEs (to Grade 1 or less [per CTCAE v5.0], with the exception of persistent adverse events or sequelae, eg, vitiligo, alopecia, hypothyroidism, diabetes mellitus, and adrenal and/or pituitary insufficiency) due to prior treatment. NOTE: Subjects previously treated with a CTLA-4-blocking antibody, subjects receiving corticosteroids with daily doses > 5 mg and <= 10 mg of prednisone equivalent for 2 weeks, and subjects with clinical symptoms and/or laboratory findings suggesting risk for adrenal insufficiency should undergo diagnostic tests for adrenal insufficiency via local laboratory. * Active pneumonitis or history of noninfectious pneumonitis that required steroids. * Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis within the previous 6 months, cerebrovascular accident, or implanted or continuous use of a pacemaker or defibrillator. * Known history of immunodeficiency. * Known additional malignancy that is progressing or required active treatment within the past 3 years. Exceptions include cancers that have undergone potentially curative therapy, eg, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, localized prostate cancer with prostate-specific antigen level below 4.0 ng/mL, in situ cervical cancer on biopsy or a squamous intraepithelial lesion on Papanicolaou smear, and thyroid cancer (except anaplastic), in situ breast cancer, and adjuvant hormonal therapy for breast cancer > 3 years from curative-intent surgical resection. * Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment. * Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous meningitis (including leptomeningeal metastases from solid tumors). * Prior allogenic tissue/solid organ transplant. * Active infection requiring systemic therapy. * Known or suspected active infection with severe acute respiratory syndrome coronavirus 2 virus. * Known or suspected active infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus (testing is not required unless suspected). * Received a live virus/attenuated vaccination within 30 days before first dose of study treatment on W1D1. * Received blood products (including platelets or red blood cells) or colony stimulating factors (including granulocyte colony stimulating factor, granulocyte/macrophage colony stimulating factor, or recombinant erythropoietin) within 30 days before the start of Screening. * History of allergy or hypersensitivity to nivolumab and/or any of its excipients. * Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator would make the subject unable to cooperate or participate in the study. * Participation in another clinical study of an investigational anticancer therapy or device within 30 days before first dose of study treatment on W1D1. Participation in the follow-up phase (receiving no study treatment) of a prior study is allowed. * Requires prohibited treatment (ie, non-protocol specified anticancer pharmacotherapy, surgery, or radiotherapy) for treatment of malignant tumor. * Has a life expectancy of less than 3 months and/or has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain) in the opinion of the treating Investigator. * Received previous CMP-001 treatment. * Pregnant or breastfeeding or expecting to conceive or donate eggs within the projected duration of the study, from the time of consent until at least 150 days after last dose of study treatment for women.

Study Objectives This is the first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study. Conditions: Malignant Solid Tumors Intervention / Treatment: DRUG: 2-4 mCi 68Ga/64Cu-FAPI-XT117, DRUG: 4-6 mCi 68Ga/64Cu-FAPI-XT117, DRUG: 6-8 mCi 68Ga/64Cu-FAPI-XT117 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * 1. signed the informed consent * 2. >=18 years old * 3. confirmed as malignant solid tumor by histopathology or clinical judgment * 4. Patients will undergo 18F-FDG PET/CT examination Exclusion Criteria: * 1. Known allergy to components of the investigational drug or its analogues * 2. suspected to have a certain disease or condition that is not suitable for the study drug * 3. Known pregnant or lactating women

Study Objectives Study to allow access to everolimus for patients who are on everolimus treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator Conditions: Neoplasms Intervention / Treatment: DRUG: Everolimus, DRUG: Sandostatin LAR Depot Location: Korea, Republic of, Thailand, Italy, Netherlands, Spain, Turkey, United States, Czechia, Russian Federation Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subject enrolled in a Novartis-sponsored, CD&MA study receiving everolimus or everolimus plus Sandostatin LAR Depot and fulfilled all their requirements in the parent study * Subject benefiting from treatment with everolimus, as determined by the guidelines of the parent protocol. Exclusion Criteria: * Subject was permanently discontinued from everolimus study treatment in the parent study. * Subject was receiving everolimus in combination with an unapproved or experimental treatment Other protocol-defined inclusion/exclusion criteria might apply

Study Objectives The purpose of the study is to evaluate the effect of Exparel on pain control and patient outcome after colon resection. The investigators will evaluate the clinical course of the patients who receive exparel as compared to the patients who do not receive exparel. Exparel is a 72 hour bupivacaine which is slowly released from lysosomes over the course of three days. A long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5 hour half-life. Conditions: Post-operative Pain, Colon Cancer, Diverticulitis Intervention / Treatment: DRUG: Bupivacaine, DRUG: Bupivacaine liposome suspension Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Elective colon resection for both benign and malignant disease * Laparoscopic, robotic and open techniques Exclusion Criteria: * emergent colon cases * cases preformed by surgeons other than Dr. Raman or Dr. Kraemer * pregnant patients * patients currently breast feeding * patients under the age of 18 * other patients unable to give informed consent * bupivacaine use within 96 hours * allergy to amide anesthetics * prisoners * caution will be used in patients with renal or hepatic failure.

Study Objectives This clinical trial studies disulfiram in treating patients with glioblastoma multiforme (GBM) who have completed radiation therapy with temozolomide. Disulfiram may block some of the enzymes needed for tumor cell growth and improve clinical outcome in GBM patients. Conditions: Glioblastoma Intervention / Treatment: DRUG: Temozolomide, DRUG: Disulfiram, DIETARY_SUPPLEMENT: Copper gluconate Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosis of histologically confirmed GBM (WHO grade IV). * At least 18 years of age. * ECOG performance status of at least 2. * Has received or is in the process of completing a course of definitive radiotherapy of at least 45 Gy with concurrent temozolomide (patient may be registered before completing radiotherapy as long as it is anticipated that s/he will complete at least 45 Gy). * Eligible for and planning to receive maintenance temozolomide after completion of definitive radiotherapy plus temozolomide. * Willing to remain abstinent from consuming alcohol while on disulfiram. * Meets the following laboratory criteria: * Absolute neutrophil count >= 1,500/mcL * Platelets >= 100,000/mcL * Hemoglobin > 9.0 g/dL (transfusion and/or ESA allowed) * Total bilirubin <= 2x institutional upper limit of normal (ULN) * AST and ALT < 3 x ULN * Calculated creatinine clearance must be > 60 mL/min (by Cockcroft-Gault) * Females of childbearing potential (defined as a female who is non-menopausal or surgically sterilized) must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Able to take oral medication. * Able to understand and willing to sign an IRB-approved written informed consent document (legally authorized representative permitted). Exclusion Criteria: * Receipt of any other investigational agents within 14 days prior to study enrollment. * Enrolled on another clinical trial testing a novel therapy or drug. * History of allergic reaction to disulfiram. * Treatment with clinically significant cytochromes P450 enzyme inducers, such as phenytoin, phenobarbital, chlordiazepoxide, diazepam, isoniazid, metronidazole, warfarin, amitriptyline within 14 days prior to the first dose of disulfiram. Of note, lorazepam and oxazepam are not affected by the P450 system and are not contraindicated with disulfiram. * Active or severe hepatic, cardiovascular, or cerebrovascular disease, including myocardial infarction within 6 months prior to enrollment, have New York Heart Association (NYHA) Class III or IV heart failure (Appendix B), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. * History of idiopathic seizure disorder, psychosis or schizophrenia. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of initiation of treatment.

Study Objectives 1. To evaluate achievement ratio of iPTH,Calcium and phosphorus after taking Cinacalcet HCL in hemodialysis subjects with mild, moderate and severe SHPT; 2. To explore the impact of Cinacalcet HCL using on the combined use of drugs; 3. To explore the difference of patients who continued or discontinued Cinacalcet HCL in real-world period from 33rd to 52nd week. Conditions: Hyperparathyroidism; Secondary, Renal Intervention / Treatment: DRUG: Cinacalcet HCl Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Parents/guardians must sign informed consent; Must be males or females whose age are 18 to 75 years old; Clinical diagnosis of chronic kidney disease on maintenance hemodialysis with secondary hyperparathyroidism; iPTH must be equal or higher than 300Pg/ml; Must not have received Calcimimetics(for example, Cinacalcet) within 6 months prior to enrollment; Must have been on maintenance hemodialysis 3 times weekly (TIW) for at least 3 months(12 weeks) prior to enrollment and must be expected to remain on hemodialysis for the duration of the study; Over 2-year life expectancy. Exclusion Criteria: * Hypocalcemia [Corrected serum calcium level less than 2.1mmol/L(8.4mg/dL); History of gastrointestinal bleeding or peptic ulcer disease and possibility of deterioration or recurrence; Severe heart disease; Epilepsy risk or history of epilepsy; Hypersensitivity to Cinacalcet; Drug abuse/addiction; Plan to receive renal transplantation within 52 weeks; Pregnant or lactating women; Pregnancy plan within 1 years, or no guarantee on taking effective contraceptive measures within 1 year after enrollment; Participated in other clinical trials within 4 weeks prior to enrollment; Received parathyroidectomy within 24 weeks prior to enrollment; Investigator judgment that patients are not suitable to enroll.

Study Objectives The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp. Conditions: Actinic Keratosis Intervention / Treatment: DRUG: BF-200 ALA gel, DRUG: Placebo to BF-200 ALA gel, PROCEDURE: Photodynamic therapy with BF-RhodoLED Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Males or females between 18 and 85 years of age (inclusive) * Presence of 4 to 8 clinically confirmed actinic keratosis (AK) target lesions of mild to moderate intensity within 1-2 fields Exclusion Criteria: * History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA * Current treatment with immunosuppressive therapy * Presence of other malignant or benign tumors of the skin within the treatment area (eg malignant melanoma, basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)) within the last 4 weeks * Confirmed diagnosis of SCC for the representative lesion by screening biopsy

Study Objectives This phase II trial studies how well erlotinib works in treating participants with skin squamous cell carcinoma that has spread to other places in the body or has come back. Drugs used in chemotherapy, such as erlotinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Conditions: Metastatic Skin Squamous Cell Carcinoma, Recurrent Skin Squamous Cell Carcinoma Intervention / Treatment: DRUG: Erlotinib 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: * Have histologically or cytologically confirmed cutaneous squamous cell carcinoma (CSCC) that is not amenable to curative therapy. If the biopsy was collected outside of MD Anderson Cancer Center (MDACC), the MDACC Pathology Department must assess and confirm the squamous cell carcinoma (SCC) diagnosis. * Have measurable disease. * Have Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Must have ability to understand and the willingness to sign a written Informed Consent Document (ICD). In the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an ICD in their language will be utilized and completed in accordance with the MDACC "Policy For Consenting Non-English Speaking Participants. * Leukocytes >= 3,000/mm^3. * Absolute neutrophil count >= 1,500/mm^3. * Platelets >= 75,000/mm^3. * Hemoglobin >= 8g/dL. * Total bilirubin =< 2 x institutional upper limit of normal (ULN). * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x ULN if alkaline phosphatase is normal, or alkaline phosphatase =< 4 x ULN if transaminases are normal. * Creatinine =< 2.0 x ULN or creatinine clearance >= 60 mL/min/1.73 m^2. * Prior radiotherapy is allowed if: (a) there is measurable disease outside the radiation field OR (b) radiotherapy was completed more than 4 weeks ago and there is clearly recurrent and growing disease within the radiation field. * Must be able to take intact tablets by mouth, or be able to take tablets dissolved in water by mouth or by a percutaneous gastrostomy tube. * Patients - both males and females - with reproductive potential (includes women who are menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures such as barrier methods, condom or diaphragm with spermicide, or abstinence throughout the study. Birth control should continue for 4 weeks after discontinuation of erlotinib therapy. Women of childbearing potential must provide a negative pregnancy test (serum beta human chorionic gonadotropin [HCG]) within 72 hours prior to first receiving protocol therapy. * Organ transplant patients are eligible as long as they do not have active signs of rejection and have adequate bone marrow function. Exclusion Criteria: * Women who are pregnant, breastfeeding, and women and men not practicing effective birth control. Erlotinib is a signal transduction inhibitor agent with the potential for teratogenic or abortifacient effects. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with erlotinib. Breastfeeding should be discontinued if the mother is treated with erlotinib. * Prior estimated glomerular filtration rate (EGFR) inhibitor therapy is not allowed (including, but not limited to, erlotinib, gefitinib, cetuximab, panitumumab, vandetanib). * Patients who are receiving any other anticancer or investigational agents at time of study enrollment. Patients may have received one other systemic therapy or investigational agent in the past, but a washout time period of at least 4 weeks and recovery of any treatment-related toxicities to < Common Terminology Criteria for Adverse Events version 4 (CTCAEv4) grade 2 is required. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib. * Patients with a history of an invasive malignancy (other than the one treated in this study) or lymphoproliferative disorder within the past 3 years. Patients with a history of adequately treated non-melanoma skin cancer, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix are allowed. * Patients with incomplete healing from previous surgery. * Patients with pulmonary fibrosis (other than in a radiated field) or active interstitial lung disease. * Patients with active gastrointestinal disease or a disorder that alters gastrointestinal motility or absorption, including lack of integrity of the gastrointestinal tract (for example, a significant surgical resection of the stomach or small bowel, inflammatory bowel disease or uncontrolled chronic diarrhea. * Patients with skin rash CTCAEv4 grade 2. * In the opinion of the investigator, patients with any condition that is unstable or could jeopardize the safety of the patient or could limit compliance with the study's requirements. These include, but are not limited to, ongoing or active infection requiring parenteral antibiotics at time of study registration, psychiatric illness that would limit compliance with study requirements or symptomatic congestive heart failure (New York Heart Association [NYHA] class II or greater), unstable angina pectoris or cardiac arrhythmia requiring maintenance medication. * Patient is unwilling or unable to discontinue prohibited concomitant therapies, (i.e St. John's wort, grapefruit juice, histamine type 2 receptor [H2] blockers/proton pump inhibitors, strong CYP3A4 inhibitors and inducers).

Study Objectives This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and primary efficacy of IBI321 in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable. Conditions: Advanced Solid Tumors Intervention / Treatment: DRUG: IBI321 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures. * Patients with advanced solid tumors who had failed standard treatment. * Male or female subjects >=18 years and <=75 years. * At least one measurable lesion per RECIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status <=1 * Life expectancy of >= 12 weeks. * Adequate hematologic and end organ function Exclusion Criteria: * Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, targeted therapy, or immunotherapy. * Failure to recover from adverse events from the most recent anti-tumor * Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection. * Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs. * Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications. * Pregnancy, lactation, breastfeeding.

Study Objectives patients undergoing modified radical mastectomy were divided into two groups. patients in catheter group were placed a catheter with open technique by the surgeon in the pectoral area. thirty minutes before extubation %1 lidocain 10 ml, %0.5 bupivacain 10 ml and 10 ml %0.9 sodium chloride were given through the catheter for postoperative analgesia. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. visual analog pain scale (VAS) scores, rescue analgesic requirement, complications were recorded and compared between two groups 1, 6, 12, 24 hours and 90 days after surgery. Conditions: Mammary Cancer Intervention / Treatment: DEVICE: catheter, DRUG: iv analgesia Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * American Society of Americans Class I-II Exclusion Criteria: * male * allergy to local anesthetics or * anticoagulant drug use * central or peripheric nerve disease * pregnancy

Study Objectives The purpose of this study is to assess the efficacy and safety of ZD6474 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy. Conditions: Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line Intervention / Treatment: DRUG: ZD6474, DRUG: Placebo, DRUG: Docetaxel Location: Czech Republic, United States, Hungary Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV) * Failure of first-line platinum-based chemotherapy Exclusion Criteria: * Mixed small cell or non-small-cell histology * Bronchoalveolar carcinoma * Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin) * Prior treatment with docetaxel

Study Objectives The purpose of this study is to determine the optimal duration of anticoagulation therapy (3 months versus 12 months) with direct oral anticoagulant (edoxaban) for isolated distal deep vein thrombosis. Conditions: Venous Thrombosis, Neoplasms, Anticoagulant Intervention / Treatment: DRUG: 12-month Edoxaban, DRUG: 3-month Edoxaban Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with newly found isolated distal deep vein thrombosis * Patients complicated with active cancer * Patients who are scheduled to be treated by anticoagulation therapy. Exclusion Criteria: * Patients with anticoagulation therapy for the index event before 10 days of allocation. * Patient under anticoagulation therapy for the purpose of other than the index event. * Patients with thrombolysis therapy or IVC filter at the Index event. * Patients with creatinine clearance less than 30 ml/min. * Patients who are expected to have a life prognosis of 3 months or less. * Patients with pulmonary embolism. * Patients who are not appropriate for the participation of the study.

Study Objectives Real-time detection of cancer cells during surgical removal of a tumor is important. Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology when the margins (edges of the tissue) are examined to see if cancer cells are present. This may take a few to several days. Patients tissue with positive (cancer cells present) margins may require additional therapies including surgery. The purpose of this study is to determine a safe dose of a new imaging agent (LUM015), like a fluorescent contrast agent or dye, that will show in the tumor area during surgery and may help facilitate visualization of tumor for its removal. Conditions: Sarcoma, Soft Tissue Sarcoma, Breast Cancer Intervention / Treatment: DRUG: LUM015 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * 18 years of age or older * Diagnosis of soft tissue sarcoma and breast cancer patients scheduled for a lumpectomy or mastectomy. * Subjects must be scheduled for surgical resection of a tumor at least 1 cm in size. * Performance status of 0 or 1 * Able to read, understand and sign an informed consent form * Must be able and willing to follow study procedures and instructions including a possible overnight stay before surgery * Otherwise healthy except for the diagnosis of cancer * ALT, AST, and total bilirubin within 1.5x institutional upper normal limits; and alkaline phosphatase within 2.5x institutional upper normal limits * Serum creatinine of 1.5 mg or less; creatinine clearance greater than 30 ml/min * May have previously received pre-operative external beam radiation therapy for this sarcoma Exclusion Criteria: * Pregnant or lactating * Prolonged QT interval: corrected QT interval (QTc) > 480 msec * Insulin dependent diabetes * History of anaphylactic reactions to any drug or contrast agent * Asthma under medical management * Uncontrolled high blood pressure * Severe, active co-morbidity * Known substance addiction * Sexually active and not willing/able to use medically acceptable forms of contraception. * Obesity defined as BMI as body mass index greater than 35 kg/meter squared. * Atopy or atopic syndrome * Known AIDS * Cannot have taken an investigational drug within 30 days of coming onto this study

Study Objectives Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010 every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be enrolled in each dosage level. Patients who tolerated and responded to treatment or who had stable disease for 3 months or longer and who subsequently progressed during the follow up phase of the study had the option to receive additional treatment with MDX-010, up to 4 cycles. Patients were followed in the study for response up to 2 years and were followed for survival status for up to 5 years after enrollment. Conditions: Prostate Cancer, Neoplasm Metastasis Intervention / Treatment: DRUG: MDX-010 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: * Histologic diagnosis of adenocarcinoma of the prostate * Metastatic prostate cancer (positive bone scan or measurable disease) * Total testosterone of less than 50 ng/dL, except for patients with prior orchiectomy, where testosterone does not need to be measured. * Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of antiandrogen and completion of a washout period and then observe disease progression. * Patients must stop using any herbal product known to decrease PSA levels (eg., saw palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior to screening. Progressive disease must be documented after discontinuation of these products. * Progressive disease after androgen deprivation (or hormone therapy). For patients with measurable disease, progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with progression in, or without any measurable disease, a positive bone scan and elevated PSA will be required. * Patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment. * No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer). * Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment. Exclusion Criteria: * Bone pain due to metastatic bone disease severe enough to require routine narcotic analgesic use. * History of severe hypersensitivity reactions to drugs formulated with polysorbate 80. * Patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo. * Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody. * Active infection requiring therapy. * Concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable.

Study Objectives Treatment efficacy of osimertinib will be assessed in patients with lung cancer harboring activating epidermal growth factor receptor (EGFR) mutations (cohort 1) and those harboring T790M (cohort 2) which were detected from circulating tumor DNA Conditions: Lung Neoplasms, EGFR Gene Mutations Intervention / Treatment: DRUG: Osimertinib Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: < Cohort 1 > * Provision of informed consent prior to any study specific procedures * Patients (male/female) must be > 18 years of age. * Locally advanced or metastatic non-small cell lung cancer, not amenable to curative surgery or radiotherapy with or without pathologic diagnosis * No prior exposure to EGFR TKI (multiple lines of prior cytotoxic chemotherapy are permitted.) * Activating EGFR mutation (G719X, exon 19 deletion, L858R, L861Q) detected from circulating tumor DNA either by PANA mutyper® or Cobas® EGFR mutation test. * Activating EGFR mutation (G719X, exon 19 deletion, L858R, L861Q) detected from tumor tissue or cytology specimen. * World Health Organization (WHO) performance status 0-2. * Patients must have a life expectancy >= 12 weeks. * Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: * Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments * Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for the institution * Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation * Male patients should be willing to use barrier contraception. * Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. * At least one lesion, not previously irradiated, that can be accurately measured at baseline as >= 10 mm in the longest diameter (except lymph nodes which must have short axis >= 15 mm) with computed tomography (CT) < Cohort 2 > * Provision of informed consent prior to any study specific procedures * Patients (male/female) must be > 18 years of age. * Locally advanced or metastatic non-small cell lung cancer, not amenable to curative surgery or radiotherapy with or without pathologic diagnosis * Progression after prior exposure to gefitinib, erlotinib, afatinib or dacomitinib. Multiple lines of prior cytotoxic chemotherapy are permitted and there is no specified order of treatment. * Patients must fulfil one of the following: 5.1) Activating EGFR mutation (G719X, exon 19 deletion, L858R, L861Q) from tumor tissue or cytology or circulating tumor DNA 5.2) Must have experienced clinical benefit from prior EGFR-TKI, according to the Jackman criteria (Jackman 2010) followed by systemic objective progression (RECIST) while on continuous treatment with EGFR-TKI * T790M mutation detected from circulating tumor DNA either by PANA mutyper® or Cobas® EGFR mutation test. * World Health Organization (WHO) performance status 0-2. * Patients must have a life expectancy >= 12 weeks. * Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: * Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments * Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution * Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation * Male patients should be willing to use barrier contraception. * Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. * At least one lesion, not previously irradiated, that can be accurately measured at baseline as >= 10 mm in the longest diameter (except lymph nodes which must have short axis >= 15 mm) with computed tomography (CT) Exclusion Criteria: * Previous treatment with AZD9291, or other 3rd generation EGFR TKI * Treatment with an investigational drug within five half-lives of the compound * Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inhibitors of CYP3A4 (at least 1 week prior) and potent inducers of CYP3A4 (at least 3 week prior) (Appendix A). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer/inhibitory effects on CYP3A4. * Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy. * Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required. * Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable * Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD * Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: Absolute neutrophil count <1.5 x 109/L Platelet count <100 x 109/L Haemoglobin <90 g/L Alanine aminotransferase >2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases Aspartate aminotransferase >2.5 times ULN if no demonstrable liver metastases or >5 times ULN in the presence of liver metastases Total bilirubin >1.5 times ULN if no liver metastases or >3 times ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases Creatinine >1.5 times ULN concurrent with creatinine clearance <50 ml/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN. * Any of the following cardiac criteria: 1. Mean resting corrected QT interval (QTc using Fredericia's formula) > 470 msec 2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block) 3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval * Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD9291 * History of hypersensitivity to AZD9291 (or drugs with a similar chemical structure or class to AZD9291) or any excipients of these agents * Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry * Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements * Previous allogeneic bone marrow transplant. * Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.

Study Objectives The West African Treatment Cohort for Hepatitis B (WATCH) study is a component of the European Commission Funded FP7 project PROLIFICA. It aims to evaluate a number of steps required to successfully treat patients with chronic hepatitis B virus infection to prevent cirrhosis and liver cancer. The first step is to determine whether screening for hepatitis B using a point of care test is feasible and effective. The second is to monitor linkage from screening into care. The third is to evaluate cheap non-invasive assessments to determine the need for treatment. The fourth is to determine what proportion of patients meet treatment eligibility criteria. The fifth step is to establish a treatment cohort which can be used to measure adherence to therapy and avoidance of HBV related complications. A parallel untreated cohort will be established to determine whether treatment criteria are relevant in this West African setting by monitoring for complications of HBV infection. Conditions: Hepatitis B, Chronic, Hepatocellular Carcinoma Intervention / Treatment: DRUG: Tenofovir disoproxil Location: Gambia, Senegal Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Adult Informed consent HBsAg positive Resident in Gambia or Senegal Exclusion Criteria: * HIV infection HCV infection Known liver cancer

Study Objectives This is a safety (Phase 1) trial using mebendazole for recurrent pediatric brain cancers that include medulloblastoma and high grade glioma, that are no longing responding to standard therapies. The drug mebendazole is an oral drug in a chewable 500 mg orange flavored tablet. It is already approved to treat parasitic infections. The purpose of this study is to determine the safety and side effects for increasing doses of mebendazole, followed by the treatment of an additional 12 patients at the best tolerated dose. Conditions: Medulloblastoma, Astrocytoma, Grade III, Glioblastoma, Anaplastic Astrocytoma, Brain Stem Neoplasms, Malignant, Oligodendroblastoma, Anaplastic Oligodendroglioma, Malignant Glioma Intervention / Treatment: DRUG: Mebendazole 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 a confirmed recurrent/progressive brain malignancy that have failed at least one prior treatment regimen. * Age for inclusion in this trial at time of patient enrollment is >= 1 year, and up to 21 years (prior to the 22nd birthday) with any of the recurrent medulloblastoma or recurrent high grade glioma may be consented and treated under this protocol. Patients who turn 22 during the course of the trial will continue to be treated. * Karnofsky Performance Score (KPS) > 50% for patients >=10 years of age. Lansky score of >= 50 for children < 10 years of age. * Life expectancy greater than 10 weeks. * Patients must have adequate organ and marrow function as defined below: * Leukocytes >= 3,000 cells per microliter * Absolute Neutrophil Count >= 750 cells per microliter * Platelets >= 75,000 cells per microliter * aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 2.5 x upper limit of normal * Total Bilirubin < 1.5 x upper limit of normal * Creatinine < 1.5 x upper limit of normal OR * Creatinine Clearance >= 60 mL/min/1.73m2 for patients with creatinine > 1.5 x upper limit of normal * The effects of mebendazole on the developing human fetus are unknown. In rats there is evidence of a teratogenic effect, although there is no evidence of adverse effect from women accidently taking mebendazole (at lower doses) during pregnancy. For this reason, women of child-bearing potential should agree to use birth control while taking mebendazole if there is a reasonable risk of pregnancy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability for patient (and if applicable parent or legal guardian) understand and the willingness to sign a written informed consent document, or for a parent or legal guardian to give assent for those cases where a very young patient is unable to understand or sign the consent. * For the patient or parent/legal guardian to be able to comply with treatment plan, study procedures and follow-up examinations. * Failed any previous front line standard of care therapy that is currently used for the patient's initial diagnosis. * Ability to swallow pills, or liquid formulation and for patient or parent/legal guardian to keep an accurate medication record. Exclusion Criteria: * Patients who have known allergy to mebendazole. 2 Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection. 3 Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy. Metronidazole and mebendazole in combination have been associated with Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis in a case report. 4 Patients who have previously taken mebendazole as part of any experimental anti-cancer protocol, and have failed this therapy. 5 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, chronic hepatitis, acute hepatitis, or psychiatric illness/social situation that would limit compliance with study requirements. 6 Pregnant women are excluded because mebendazole is a Class C agent with the potential for teratogenic effects. Because it is not known if mebendazole is excreted in breast milk, breastfeeding should be discontinued if the mother is treated with mebendazole. 7 Patients with human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C positive; or with a history of chronic active hepatitis or cirrhosis. 8 Patients with a history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product administration or may interfere with the interpretation of the results. 9 Patients who are not available for follow-up assessments or unable to comply with study requirements.

Study Objectives The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams. External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching. Conditions: Genital Warts Intervention / Treatment: DRUG: Imiquimod, DRUG: 3.75% imiquimod cream, DRUG: placebo cream Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * In good general health * Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 warts * Negative pregnancy test (for women who are able to become pregnant) Exclusion Criteria: * Women who are pregnant, lactating or planning to become pregnant during the study * Evidence of clinically significant or unstable disease (such as stroke, heart attack) * Have any of the following conditions: HIV infection; current or history of high risk HPV infection (e.g., HPV 16, 18, etc.); outbreak of herpes genitalia in the wart areas; internal warts requiring or undergoing treatment; dermatological disease (e.g., psoriasis) or skin condition in the wart areas * Have received specific treatments in the treatment area(s) within the designated time period prior to study treatment initiation.

Study Objectives RATIONALE: Using fluorescence imaging may determine the extent of kidney tumors and help in planning surgery. PURPOSE: This phase I trial is studying the best way to give indocyanine green (ICG) fluorescence imaging in finding tumors in patients with kidney tumors Conditions: Recurrent Renal Cell Cancer, Stage I Renal Cell Cancer, Stage II Renal Cell Cancer Intervention / Treatment: PROCEDURE: fluorescence imaging, PROCEDURE: laparoscopic surgery, DRUG: indocyanine green Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: SINGLE

Inclusion Criteria: * Patients with a computed tomography (CT) scan or magnetic resonance imaging (MRI) on preoperative assessment showing evidence of a renal cortical tumor; the renal tumor must be stage T1a/bT2 * Due to concerns of surgical and anesthetic effects on the fetus, women of child bearing age who are considered to still be fertile must undergo a urine pregnancy test prior to inclusion in the study; only women with negative urine pregnancy tests prior to surgery will be included; if a women is found to have a positive urine pregnancy test, surgery and potential inclusion in the study will be deferred until after delivery of the baby; should a woman become pregnant or suspect that she is pregnant prior to surgical management, she should inform her treating physician immediately; although it is known that ICG is released from the body through the hepatic system, breastfeeding mothers will be excluded from the study due to the unknown side effects on the infant in the breastfeeding population * The subject must be able to comply with the study procedures * All subjects must have the ability to understand the risks, benefits, and alternatives of the study and the willingness to sign a written informed consent Exclusion Criteria: * Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as total bilirubin greater than 1.5 X normal and/or serum glutamic oxaloacetic transaminase (SGOT) greater than 2 X normal * Subject has uremia, serum creatinine greater than 2.0 mg/dl * Subject has previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes * Subject in whom the use of x ray dye or ICG is contraindicated including development of adverse events when previously or presently administered * Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure * Subject is actively participating in another drug, biologic and/or device protocol * The presence of medical conditions contraindicating general anesthesia or standard surgical approaches * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Study Objectives The purpose of this study is to evaluate the safety and efficacy of parsaclisib when combined with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular lymphoma (FL). Conditions: Lymphoma Intervention / Treatment: DRUG: Parsaclisib, DRUG: Hexal, DRUG: Gazyvaro Location: Hungary, Italy, Spain, Denmark, United States, Czechia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed FL. * Documented CD20+ FL. * Relapsed or refractory to any prior rituximab-containing regimen. * Previously treated with a maximum of 4 cancer-directed treatment regimens. * At least 1 measurable lesion > 1.5 cm in at least 1 dimension by computed tomography or magnetic resonance imaging. * Must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Exclusion Criteria: * Clinical evidence of transformation to a more aggressive subtype of lymphoma or Grade 3B FL. * History of central nervous system lymphoma (either primary or metastatic). * Allogeneic stem cell transplant within the last 6 months, or active graft-versus-host disease following allogeneic transplant or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug administration. * Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. * Prior treatment with a selective PI3Kδ inhibitor or a pan PI3K inhibitor. * Prior treatment with bendamustine (within 12 months of the start of study treatment). Subjects with prior bendamustine treatment (> 12 months before the start of study treatment) are eligible if they meet the following criteria: * Did not discontinue because of tolerability concerns. * Achieved either partial or CR to the bendamustine regimen of at least 12 months in duration before relapse/progression. * Experienced progression following a regimen containing an alkylating agent. * Received prior obinutuzumab. * Received rituximab within 4 weeks of study start. * Prior treatment-related toxicities that have not resolved to <= Grade 1 before the date of study drug administration except for stable chronic toxicities (<= Grade 2) not expected to resolve (eg, stable Grade 2 peripheral neurotoxicity). * Received any prior monoclonal antibody (except an anti-CD20 antibody) within 90 days before the date of study start. * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (eg, subjects in whom re-administration with rituximab would be contraindicated for safety reasons).

Study Objectives This is a clinical research study of interferon (IFN) plus chemotherapy with the standard combination of Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD). The treatment will be given to patients with Hodgkin's disease. The study will look at whether adding IFN to ABVD improves the immune response against Hodgkin's disease, and will determine whether the toxicity of ABVD is increased by adding IFN. Conditions: Lymphoma Intervention / Treatment: DRUG: Interferon-2A, DRUG: Adriamycin, DRUG: Bleomycin, DRUG: Velban, DRUG: Dacarbazine 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: * Hodgkin's disease patients who relapse after radiation therapy alone, or in combination with Novantrone, Oncovin, Velban, and Prednisone (NOVP); and previously untreated patients with stage III and IV who are eligible for standard ABVD therapy. * Must have adequate bone marrow reserve Absolute neutrophil count (ANC) > 1,000/uL, Platelets > 100,000 * Left ventricular ejection fraction (LVEF) >= 50%, serum creatinine < 2mg/dl, serum bilirubin < 2mg/dl Exclusion Criteria: * No prior therapy with Mustargen Oncovin Procarbazine Prednisone (MOPP). * No severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.

Study Objectives The purpose of this study is to determine the whether Lipiodol can be used as an imaging biomarker, predicting tumor response to therapy in patients with primary and metastatic liver cancer. Lipiodol-based transarterial chemoembolization (TACE) has been an accepted standard of care procedure for unresectable liver lesions for several decades. Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s). Response to therapy will be evaluated every 1, 3 and 6 months by clinic visits, MRI/CT/PET scans and blood tests (to include assessment of liver function and tumor markers). Conditions: Liver Cancer Intervention / Treatment: DRUG: Lipiodol Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * 18 years of age or older. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. * Childs class of A or B (up to 9). * Hepatocellular carcinoma (HCC) is unresectable with liver-predominant disease or subject has HCC and refused surgery or subject is diagnosed hepatic metastases from any solid tumor. (Multifocal HCC is acceptable, no diffuse HCC). * Subject is voluntarily participating in the study and has signed the informed consent. Exclusion Criteria: * Contraindications to doxorubicin, cisplatin, or mytomycin-c administration (or specific mixture of chemotherapy drugs to be used). * Evidence of severe or uncontrolled systemic diseases. * Congestive cardiac failure >NYHA class 2 MI within 6 months, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, unstable angina, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial. * Known allergy to Lipiodol (Ethiodol), poppy seed oil, or iodinated contrast agents (that cannot be adequately mitigated with pre-procedure medication). * Main portal vein thrombosis is excluded; segmental or branch portal vein thrombosis is acceptable. * Subject is breastfeeding. * Subject is pregnant

Study Objectives This is a phase I/II, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with NRAS mutant advanced melanoma . Conditions: Melanoma Intervention / Treatment: DRUG: HL-085 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed unresectable Stage III or Stage IV melanoma according to AJCC (Version 7, 2010). * Subjects must have NRAS mutation in melanoma. * Chemotherapy, immunotherapy or radiotherapy >= 4 weeks prior to starting the study treatment. Surgery (except for tumor biopsy) or severe trauma <= 14 days prior to starting the study treatment. * ECOG performance status of 0-1. * Life expectancy >= 3 months. * Ability to take the medicine orally. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Prior therapy with a MEK-inhibitor * Patients with known hypersensitivity to study drug ingredients or their analogues. * Active central nervous system (CNS) lesion. * ECG QTcB>=480msec in screening, or history of congenital long QT syndrome. * Subjects with bleeding symptoms at Grade 3 (NCI-CTCAE v4.03) within 4 weeks prior to starting study treatment. * Uncontrolled concomitant diseases or infectious diseases. * Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.). * History of HIV,HCV,HBV infection. * Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded. * Serum HCG test is positive. * Other conditions that influence the results and increase the risk of study.

Study Objectives Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin. Conditions: Endometrial Cancer Intervention / Treatment: DRUG: AEZS-108 / zoptarelin doxorubicin, DRUG: doxorubicin Location: Canada, United States, Austria, Czechia, Poland, Israel, Italy, Netherlands, Ukraine, United Kingdom, Denmark, Ireland, Russian Federation, Bulgaria, Finland, Belarus, Spain, Belgium, Norway, Germany, Romania, Bosnia and Herzegovina Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Women >= 18 years of age * Histologically confirmed endometrial cancer * Advanced (FIGO stage III or IV), recurrent or metastatic disease. * Measurable or non-measurable disease that has progressed since last treatment. * 5. Patients with advanced, recurrent or metastatic endometrial cancer who have received one chemotherapeutic regimen with platinum and taxane (either as adjuvant or as first line treatment) and who have progressed. * Availability of fresh or archival FFPE (formalin-fixed and paraffin-embedded) tumor specimens for analysis of LHRH (luteinizing hormone releasing hormone) receptor expression. Exclusion Criteria: * ECOG (Eastern Cooperative Oncology Group) performance status > 2. * Inadequate hematologic, hepatic or renal function * Red blood cell transfusion within 2 weeks prior to anticipated start of study treatment. * History of myocardial infarction, acute inflammatory heart disease, unstable angina, or uncontrolled arrhythmia within the past 6 months. * Impaired cardiac function defined as left ventricular ejection fraction (LVEF) < 50 % (or below the study site's lower limit of normal) as measured by MUGA (multigated radionuclide angiography) or ECHO (echocardiography). * Concomitant use of prohibited therapy (specified in protocol) * Chemo-, immune-, or hormone-therapy within 5 elimination half life times or 4 weeks prior to randomization, whichever is the shorter. Radiotherapy (including pre- or post-operative brachytherapy) within 4 weeks prior to randomization. * Previous anthracycline-based chemotherapy (daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone and valrubicin), in any formulation. * Anticipated ongoing concomitant anticancer therapy during the study. * History of serious co-morbidity or uncontrolled illness that would preclude study therapy, such as active tuberculosis or any other active infection. * Brain metastasis, leptomeningeal disease. * Pregnant or lactating female or female of child-bearing potential not employing adequate contraception. * Subjects with known hypersensitivity to peptide drugs, including LHRH agonists. * Receipt of 2 or more prior cytotoxic chemotherapy regimens for advanced, recurrent, or metastatic endometrial cancer. * Prior treatment with AEZS-108. * Use of LHRH agonist or antagonist treatment within 6 months prior to randomization. * Malignancy within last 5 years except non-melanoma skin cancer. * Any concomitant disease or condition which would interfere with the subjects' proper completion of the protocol assignment. * Concomitant or recent treatment with other investigational drug (within 4 weeks or 5 elimination half life times prior to anticipated start of study treatment). * Lack of ability or willingness to give informed consent. * Anticipated non-availability for study visits/procedures.

Study Objectives The purpose of this study is to obtain preliminary information on the potential of 99m Tc-EC-DG SPECT imaging to distinguish cancer from non cancer. Conditions: Head and Neck Cancer Intervention / Treatment: DRUG: 99mTc-EC-DG Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Treatment naive patients with histologically proven cancer of the head and neck * T4 primary tumor (all sites), N2 or N3 locoregional disease (all sites) * At least one measurable site of disease * At least 18 years of age * Karnofsky performance status > or = 70% or ECOG <2 * Able to tolerate SPECT/CT imaging * Adequate bone marrow function * Adequate liver function * Adequate renal function * Written consent from patients * Female patients of childbearing potential must have a negative pregnancy test within 0-7 days prior to the first SPECT study Exclusion Criteria: * Diabetics with insulin dependence or blood sugar levels >200 mg/dL prior to imaging * Patient weight above the SPECT/CT table weight limit * Pregnant and/or lactating female * Unequivocal demonstration of metastatic disease * Patients unwilling to or unable to comply with protocol

Study Objectives To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53. Conditions: Advanced Solid and Hematological TP53wt Tumors Intervention / Treatment: DRUG: HDM201, DRUG: ancillary treatment Location: Germany, Japan, Netherlands, Spain, United States, Singapore, Taiwan, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patient with a TP53wt locally advanced or metastatic solid malignancy and with measurable or non-measurable (but evaluable) disease as determined by RECIST 1.1 criteria. * Patients with the TP53wt hematological tumors (AML, ALL, HR-MDS) who have failed prior therapies or who are considered inappropriate candidates for standard induction therapy. Other protocol-defined inclusion criteria may apply Exclusion Criteria: * Prior treatment with compounds with the same mode of action * Subjects with significant or uncontrolled cardiovascular disease * History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism * Previous and concomitant therapy that precludes enrollment, as defined in the protocol * Known Human Immunodeficiency Virus (HIV) infection and/or active Hepatitis B or Hepatitis C infection * Patients who have undergone major surgery within the 2 weeks prior to starting study treatment or who have not fully recovered from previous surgery * Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation * Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives The goal of this clinical research study is to compare the effectiveness of a white blood cell transfusion with radiated cells to a white blood cell transfusion with cells that have not been radiated. The safety of this procedure will also be studied. Conditions: Leukemia Intervention / Treatment: PROCEDURE: White Blood Cell Transfusion Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: TRIPLE

Inclusion Criteria: * Diagnosis of hematologic malignancy admitted to the Leukemia service. * Severe neutropenia defined as Absolute neutrophil count (ANC) less than or equal to 1000. * Persistent fever and/or signs of life threatening infection despite 48 hours on antibiotics. * Sign a written informed consent form. * Greater than 18 years of age. Exclusion Criteria: 1) None

Study Objectives RATIONALE: L-arginine supplements may improve the quality of life and erectile function in men who are prostate cancer survivors. PURPOSE: This randomized phase II trial is studying how well L-arginine supplementation works with or without enzyme inhibitors in treating erectile function and quality of life of prostate cancer survivors previously treated with radiation therapy. Conditions: Male Erectile Disorder, Prostate Cancer, Radiation Toxicity Intervention / Treatment: OTHER: Placebo, DRUG: Oral L-Arginine, DRUG: Oral L-Arginine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

INCLUSION CRITERIA: * Male prostate cancer survivor previously treated with radiotherapy and who identifies himself as concerned with sexual quality of life, including erectile dysfunction. (seed implants are eligible) * Had successful sexual activity prior to the commencement of radiotherapy. * Erectile dysfunction, defined as inability to achieve or maintain an erection sufficient for satisfactory sexual performance * Interested in sexual activity and agrees to make at least one sexual intercourse attempt with a partner every week during the study. * The usage of PDE-5 inhibitors will be voluntary and will serve as a stratification factor. Patients taking PDE-5 inhibitors must agree to assume the responsibility for the cost of PDE-5 inhibitor treatment during the protocol period (8 week period) as this is not covered in the cost of the trial. * Patients currently taking PDE-5 inhibitors sildenafil (Viagra®, Pfizer Pharmaceuticals), tadalafil(Cialis®, Lilly ICOS, LLC), and vardenafil (Levitra®, Bayer Healthcare / Schering Plough Corp.)must agree to take the medication only as prescribed by their treating physician. * Patients taking PDE-5 inhibitors as part of this study must be on a stable dose of drug for at least one month prior to study entry. * Must be able to take oral medications. * > 6 months following completion of all cancer therapy * No evidence of prostate cancer * Prior malignancies allowed if no evidence of recurrent disease. * If previously taken LHRH agonist androgen suppression (e.g, Lupron, Zoladex), anti-androgen (e.g., Casodex, Eulexin, Nilandron), or estrogenic (e.g., diethylstilbestrol) agents, serum testosterone must have returned to the laboratory normal range * No planned surgery while on protocol or for 4 weeks following completion of protocol * Prior cystoscopy is permitted. * Age > 18 * ECOG performance status 0/1. * Patients must agree not to start taking an herbal product for erectile dysfunction during the eight weeks of study intervention. EXCLUSION CRITERIA: * No other concurrent erectile dysfunction therapies permitted (i.e. vacuum pump,cavernosal injections, and other drug therapies). Past use of these and other therapies permitted if the patient can meet the inclusion criteria above. * No testosterone supplementation permitted. * Use of LHRH agonist androgen suppression (e.g, Lupron, Zoladex), anti- androgen (e.g., Casodex,Eulexin, Nilandron), or estrogenic (e.g., diethylstilbestrol) agents within the last 6 months. * Prior prostate or lower genitourinary surgery (bladder, penis, urethra, testicles)including transurethral resection of prostate (TURP). (Prior vasectomy is allowed) * Serious cardiovascular disease (unstable angina, supraventricular arrhythmia, myocardial infarction, symptomatic congestive heart failure, cardiac arrhythmia, coronary artery bypass surgery within 6 months prior to registration). * Hypotension (<90/50mm Hg), or uncontrolled hypertension (>170/100 mm Hg) * Stroke or spinal cord injury within 6 months before registration. * Patients on Persantine, heparin, Lovenox, warfarin, ginkgo biloba, Plavix, Disalcid, other blood-thinning medication or with a history of bleeding disorders will be excluded.(Aspirin < 325mg allowed) * Current use of cimetidine, ketoconazole, itraconazole, erythromycin, or ritonavir. Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up. * Current or prior use of any organic nitrate within the last 6 months (e.g., use of nitroglycerin) * May not receive other investigational agents or devices during 30 days prior to start of study drug. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ArginMax (l-arginine, ginseng, or ginkgo biloba)

Study Objectives The objective of this study is to determine the incidence of complete and partial response and the duration of response in patients with recurrent or resistant Hodgkin's disease (HD) treated with sequential administration of oral 6-Thioguanin (6-TG) after IV Methotrexate (MTX). Conditions: Hodgkin's Disease Intervention / Treatment: DRUG: Methotrexate, DRUG: Leucovorin calcium, DRUG: 6-Thioguanine 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 with histologic proof of HD who are in relapse and have failed > or = to 2 prior chemotherapy regimens. * Patients must have a life expectancy of at least 8 weeks. * All patients must have ECOG performance level rating of < or = to 2. * Patients or their parents (guardian) must sign an informed consent indicating that they are aware of the investigational nature of the study. * Patients must have recovered from the toxic effects of prior therapy before entering this study or at least 2 weeks should have elapsed since the end of last course of CT. * Patients must have adequate liver function (bilirubin < or = to 2.0 mg/dl, SGOT less than 1.5 times normal (unless it is due to disease), adequate renal function (creatinine < or = to 1.5 mg/dl, creatinine clearance > or = to 60 ml/min/1.73 m2). * Patients should have a granulocyte count > or = to 500/gL and a platelet count > or = to 100,000/uL (unless due to disease involvement of the bone marrow). * Male and female patients of child-bearing age should use effective methods of contraception, if sexually active. Exclusion Criteria: * Patients with active infections or significant medical conditions other than their malignancy shall be excluded. * Patients with HD who had prior MTX or 6-TG should be excluded.

Study Objectives The purpose of this study is to learn more about the ability of a substance called arginine to improve the functioning of the immune system in people with a certain type of brain tumor. This could lead to improvements in a type of treatment for brain tumors called immunotherapy. The immune system includes organs, cells, and substances in the body that fight infection and disease. Immunotherapy is a type of treatment that uses the immune system as a tool to seek out and destroy abnormal cells. Immunotherapy requires that the immune system be working properly. Arginine is a normal component of protein (an amino acid) that we all consume in foods such as red meat, poultry, fish, and dairy products and that our bodies can make. Arginine helps the immune system function normally. Recent research has shown that certain types of brain tumors decrease the amount of arginine in the body leading to impaired immune system function. This may interfere with the ability of immunotherapy to fight abnormal cells. We would like to see if giving people with brain tumors arginine in powder form will make their immune systems work better. Conditions: Glioblastoma Multiforme Intervention / Treatment: DRUG: arginine in powder form, DRUG: Silica and cellulose placebo powder Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: TRIPLE

Inclusion Criteria: * Age 18 and above. * Imaging consistent with GBM without clinical indication for primary CNS lymphoma or abscess, as determined by the treating physician. * Patient must be planned to proceed to definitive surgery intended for tumor resection, rather than needle biopsy, within a reasonable time frame from initial evaluation (7-14 days). * Patient must be neurologically stable, allowing for reasonable time frame between initial evaluation and subsequent surgical procedure (7-14 days). * Patient must have initial KPS greater than 80. * At the time of initial evaluation the patient must be on a stable dose of steroid medication if indicated. * Patient must have laboratory values, as determined by institutional controls, within the following parameters: * White blood cell count above lowest level for normal range * Renal function within normal limits (creatinine, BUN) * Liver function within normal limits (AST/ALT, total bilirubin, alkaline phosphatase) * Written informed consent is obtained prior to initiation of study procedures. Exclusion Criteria: * Known autoimmune condition, underlying immune disease, or use of immunomodulatory prescription drugs (aside from steroids) for any medical condition. * Prescribed vasodilator medications: Phosphodiesterase Inhibitors: Sildenafil (Viagra), Nitrates, Alpha blockers: Terazosin (Hytrin), doxazosin (Cardura), alfuzosin (Uroxatral), tamsulosin (Flomax), and prazosin (Minipress). * Glaucoma * Known Herpes simplex virus (i.e. cold sores) * History of myocardial infarction or coronary artery disease. * Known allergy or intolerance to arginine. * Uncontrolled or poorly controlled seizures. * KPS less than 80. * Known renal or hepatic insufficiency or failure. * Known deficiency or dysfunction of intestinal absorption or motility. * History of other malignancy regardless of current status or treatment. * Underlying psychiatric condition or altered mental status that would violate stringent acquisition of informed consent or potentially preclude, in the opinion of the investigator, compliance with study requirements * Pregnancy

Study Objectives 1.1 To collect pathological tumor specimens of patients with metastatic colorectal cancer in a prospective fashion for correlative studies of response to an oxaliplatin based chemotherapy regimen. 1.2 To determine a gene expression profile that predicts response to an oxaliplatin based chemotherapy regimen in this cohort of patients. Conditions: Colonic Diseases, Cancer Intervention / Treatment: DRUG: Oxaliplatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * All patients, >18 years of age, with metastatic/recurrent colorectal cancer are eligible. * Patients must have a life expectancy of at least 12 weeks. * Patients must have a Zubrod performance status of 0-2. * Patients must sign an informed consent. * Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count > 100,000/mm3 and absence of a regular red blood cell transfusion requirement. * Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal. * The patient must agree to a biopsy of a sample of tumor for correlative studies. * The patient is an appropriate candidate for oxaliplatin/capecitabine based chemotherapy. * The patient must have measurable disease. Exclusion Criteria: * Patients with symptomatic brain metastases are excluded from this study. * Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception. * Patients may receive no other concurrent chemotherapy or radiation therapy during this trial. * Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial. * Patients may not have received oxaliplatin previously. * Patients with a prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency, or known hypersensitivity to platinum compounds or any of the components of the study medications.

Study Objectives To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or without cisplatin in terms of objective response rates (WHO criteria). Conditions: Head and Neck Neoplasms Intervention / Treatment: DRUG: docetaxel and cisplatin, DRUG: docetaxel Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with locally advanced head and neck cancer (T3 and T4 tumors), epidermoid, histologically proven without metastasis; the primitive site of which is the oral cavity, the oropharynx, the hypopharynx or the larynx. * Locally advanced tumors which are inoperable, or operable but the patient refuses surgery. * Age >= 18 years and <= 70 years. * PS < 2. * Satisfactory hematological, hepatic and renal functions: (PN >= 2000/mm3, platelet count >= 100,000/mm3, hemoglobin >= 10g/dl, serum creatinine <= 120 µmol/l or creatinine clearance >= 60 ml/mn, normal total bilirubin, AST (SGOT) and ALT (SGPT) <= 2.5 x the upper limit of normal (ULN) of each center, PAL <= 5 x LNS; patients with AST or ALT > 1.5 x LNS combined with PAL > 2.5 x LNS will not be eligible for this trial. Exclusion Criteria: * Any metastases (other than cervical ganglia). * Cancer of the cavum and the facial structure. * Any previous chemotherapy or radiotherapy, irrespective of the reason. * Any surgery for epidermoid carcinoma in the upper aerodigestive tracts. * Weight loss >=10% of total body weight during the last 3 months. * Any other previous cancer excepting in situ or cutaneous cervical cancer (spinocellular or basocellular). * Pregnant or nursing women; women of childbearing potential must use an appropriate method of contraception. * Poorly controlled progressive infection. * Peripheral neuropathy with NCI grade >= 2. * Neurological or psychiatric disease (dementia, seizures, etc.) that is not compatible with good understanding and sufficient compliance with treatment. * Any other poorly controlled progressive disease, such as heart failure, symptomatic cardiac rhythm disorders, progressive angina pectoris, or respiratory impairment. * Any other concomitant investigational treatment. * Any other concomitant anticancer treatment. * Allergy to polysorbate 80. * Definitive formal contraindication to corticosteroids. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months. Conditions: Cancer, Ovarian Cancer Intervention / Treatment: DRUG: recombinant interleukin-21, DRUG: caelyx (pegylated liposomal doxorubicin) Location: France, Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Advanced epithelial Ovarian Cancer (stage IIB-IV) * Persistent or progressive disease after or relapse within one year of completion of first line therapy * Measurable or assessable disease * Eastern Cooperative Oncology Group status less than or equal to 2 Exclusion Criteria: * History of any other active malignancy * Signs of CNS metastasis * More than one prior chemotherapy regimen * Radiotherapy (bone) less than 4 weeks prior to start of treatment and radiotherapy (visceral) less than 8 weeks * First line chemotherapy completed at least 1 month prior to start of treatment

Study Objectives The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma. Conditions: Tumors Intervention / Treatment: DRUG: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody Location: Finland, Norway, Canada, Germany, Turkey, Italy, Brazil, Netherlands, Spain, Denmark, United States, Switzerland, United Kingdom, Ireland, Austria, Russian Federation, France, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically documented advanced solid tumors that meet protocol-defined cohort specifications, have progressive disease at study entry, and have received at least one line of prior systemic therapy or for which no alternative therapy to prolong survival exists * Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or in freshly cut and unstained slides (exceptional cases) with an associated pathology report for central testing * Measurable disease as defined by RECIST v1.1 or disease-specific criteria for prostate cancer and malignant pleural mesothelioma * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Negative serum pregnancy test result within 14 days prior to study drug among women of childbearing potential * Life expectancy > 3 months Exclusion Criteria: * Malignancies other than disease under study within 5 years prior to Day 1 of Cycle 1 except those with a negligible risk of metastasis or death * Uncontrolled tumor-related pain * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures >=1 time per month * History of asymptomatic or symptomatic central nervous system (CNS) metastasis * Leptomeningeal disease * Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated but without evidence that disease has been clinically stable for >=2 weeks prior to Day 1 of Cycle 1 * Pregnant and lactating women * Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1 * Severe infection within 4 weeks prior to Day 1 of Cycle 1 * Oral or IV antibiotics within 2 weeks prior to Day 1 of Cycle 1 * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation * History of autoimmune disease except treated/stable hypothyroidism, Type 1 diabetes mellitus, and protocol-specified dermatologic conditions * Active tuberculosis * Signs or symptoms of infection within 2 weeks prior to Day 1 of Cycle 1 * Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, or anti-programmed cell death-1 (PD-1) or anti-PD-L1 therapeutic antibodies * Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to Day 1 of Cycle 1, or anticipated requirement for systemic immunosuppressive medications during the trial

Study Objectives The main purpose of this study is to see if Positron Emission Tomography (PET-Imaging) with 89Zr labeled trastuzumab can detect trastuzumab (HER2) positive breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: 89Zr-Trastuzumab Human Dosimetry and Safety, DRUG: HER2 Positive Lesion Detection and Safety Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Female patients 18 years of age or older * Cohort 1: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio > 2 biopsy proven breast cancer * Cohort 2: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio > 2 OR HER2negative (0 or 1+, 2+ and FISH negative) biopsy-proven breast cancer * Primary or recurrent/metastatic lesion size >= 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination * Able to give informed consent * Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 89Zr-trastuzumab) is negative * Patients currently receiving trastuzumab therapy with or without other types of systemic therapy can participate if their disease progresses (development of new lesion(s) or worsening of known lesion(s) based on imaging modalities or physical examination. Exclusion Criteria: * Patients with other invasive malignancies, with the exception of non- melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years * Unable to tolerate 60 min of PET imaging per imaging session

Study Objectives The purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin (GEMOX) with carboplatin + paclitaxel (CP) to determine if there is a difference in response and safety between the two drug combinations for the treatment of advanced non-small cell lung cancer (NSCLC). Conditions: Carcinoma, Non-Small-Cell Lung Intervention / Treatment: DRUG: gemcitabine/Eloxatin (GEMOX), DRUG: carboplatin/paclitaxel (CP) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Newly diagnosed, Stage IIIb or IV NSCLC, chemo or other systemic therapy naive * One (1) unidimensionally measurable lesion * ECOG Performance Status of 0 or 1, no peripheral neuropathy >Grade 1 * Patients with clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone at registration will be eligible. Patients who have received cranial radiation for brain metastases must be at least 4 weeks from last radiation treatment. * Recovery in full from any previous surgical procedure * No history of an acute cardiac or CNS event within 6 months of entry or current clinical evidence of congestive heart failure or non-stable coronary artery disease Exclusion Criteria: * Hypersensitivity to any of the 4 study drugs * Concurrent immunotherapy or participation in any investigational drug study within 4 weeks * Serious uncontrolled intercurrent medical or psychiatric illness and organ allograft * History of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder) * Patient is a pregnant or lactating female

Study Objectives Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors. This phase I trial is studying how well EF5 works in detecting the presence of oxygen in tumor cells in patients with solid tumors that can be biopsied or removed by surgery Conditions: Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: EF5, PROCEDURE: therapeutic conventional surgery, PROCEDURE: biopsy, OTHER: pharmacological study Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed tumor or highly suspicious cancerous mass based on imaging and clinical signs but not indicative of a direct biopsy/cellular diagnosis preceding surgery * Must have a clinical condition or physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection * Performance status - ECOG 0-2 * Life expectancy not specified * WBC greater than 2,000/mm^3 * Platelet count greater than 100,000/mm^3 * Bilirubin less than 2.0 mg/dL * Creatinine less than 2.0 mg/dL * Creatinine clearance greater than 50 mL/min * No significant cardiac disease that would preclude the safe use of general anesthesia * No significant pulmonary disease that would preclude the safe use of general anesthesia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 month after study * No history of grade III or IV peripheral neuropathy * See Disease Characteristics

Study Objectives This phase II trial is studying how well giving cisplatin and irinotecan together with bevacizumab works in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor 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 tumor-killing substances to them. Bevacizumab may also stop the growth of small cell lung cancer by blocking blood flow to the tumor. Giving cisplatin and irinotecan together with bevacizumab may kill more tumor cells. Conditions: Extensive Stage Small Cell Lung Cancer Intervention / Treatment: DRUG: cisplatin, DRUG: irinotecan hydrochloride, BIOLOGICAL: bevacizumab, 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: * All patients must have histologically or cytologically documented small cell carcinoma of the bronchus * The extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive stage patients are defined as those patients with extrathoracic metastases, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy * Measurable or Non-measurable Disease * No prior chemotherapy or investigational therapy for SCLC * Radiation therapy must have been completed at least three weeks before initiation of protocol therapy * No major surgical procedure within 28 days prior to starting treatment and fully recovered * No minor surgical procedure (mediastinoscopy or core biopsy) within 7 days prior to starting treatment * ECOG performance status: 0-2 * No "currently active" second malignancy other than non-melanoma skin cancers * No CNS metastases; patients with a history of CNS metastases will NOT be eligible even if they have completed a course of CNS radiotherapy; all patients will have a screening brain CT or MRI to rule out occult CNS metastases * No recent history of CVA (within 6 months) * No serious or non-healing wound ulcer or bone fracture * Patients with a history of significant bleeding episodes (e.g., hemoptysis, bleeding diathesis, upper or lower GI bleeding) are not eligible; patients with trace blood in the sputum ("blood tinged sputum") are eligible * No myocardial infarction or significant change in anginal pattern within one year or current congestive heart failure (NYHA Class 2 or higher) * Patients with a history of hypertension must be well controlled (< 150/90) on a stable regimen of anti-hypertensive therapy * No HIV-positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with the protocol treatment; (patients with immune deficiency are at an increased risk of lethal infections when treated with marrow-suppressive therapy) * No chronic daily treatment with aspirin (> 325 mg/day) or on non-steroidal antiinflammatory agents known to inhibit platelet function; no treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), cilostazol (Pletal), or other antiplatelet agents * No clinically significant peripheral neuropathy (grade >= 2) * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * No treatment with therapeutic anticoagulation; prophylactic anticoagulation for central venous access devices is allowed provided requirements of INR < 1.5 and PTT < 1.2 x ULN are met; caution should be taken in treating patients with low dose heparin or low molecular weight heparin for DVT prophylaxis as there may be an increased bleeding risk with bevacizumab * No current and/or recent (within 1 month) use of a thrombolytic agent; low dose thrombolytic therapy for maintenance of central venous catheter is allowed * No clinically significant peripheral arterial disease * Non-pregnant and non-nursing; the effect of the combination of bevacizumab, cisplatin, and irinotecan on the fetus and infant is unknown * Granulocytes >= 1,500/μl * Platelets >= 100,000/μl * Serum Creatinine =< ULN * Total Bilirubin < 2.0 mg/dl * SGOT < 2 x ULN * INR < 1.5 * PTT < 1.2 x ULN * Urine protein (dipstick) < 1+

Study Objectives The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' adherence to sunscreen application. Conditions: Dermatology Disease, Skin Cancer Intervention / Treatment: OTHER: Patient Educational Materials Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * 18 years of age or older at time of consent, may be men or women. * Able to adhere to the study visit schedule and other protocol requirements. * Capable of giving informed consent. Exclusion Criteria: * Non-English speaking individuals * Individuals with a known allergy to sunscreens * Individuals with a history of psoriasis, because phototherapy has been shown to be beneficial for their skin condition

Study Objectives An open-label, single center study with 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer in dynamic of chemo+targeted therapy, where the primary endpoint of the study is to find out the correlation between the HER2 expression measured by 99mTc-DARPin G3 SPECT and standard histopathology from primary tumor in dynamic of chemo+targeted therapy. Conditions: HER2-positive Breast Cancer, Female Intervention / Treatment: DRUG: 99mTc-DARPinG3 Location: Russian Federation Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Subject is > 18 years of age; * Diagnosis of primary breast cancer with tumour size >= 20 mm and with possible lymph node metastases; * Availability of results from HER2 status previously determined on material from the primary tumor: HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive; * In neoadjuvant all patients should receive standard chemo-targeted therapy according to the DCH+P (docetaxel + carboplatin+ trastuzumab+ pertuzumab) scheme; * Injection of 99mTc-DARPinG3 at the dosage 3000 µg before and after 2 and 4 courses of chemo+targeted therapy in each HER2-positive breast cancer patient; * Biopsies should be performed in all patients HER2-positive breast cancer patients before and after 2 and 4 courses of chemo+targeted therapy with evaluation of HER2 expression; * Hematological, liver and renal function test results within the following limits: * White blood cell count: > 2.0 x 109/L * Hemoglobin: > 80 g/L * Platelets: > 50.0 x 109/L * ALT, ALP, AST: =< 5.0 times Upper Limit of Normal * Bilirubin =< 2.0 times Upper Limit of Normal * Serum creatinine: Within Normal Limits * A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination; * Subject is capable to undergo the diagnostic investigations to be performed in the study; * Informed consent Exclusion Criteria: * Second, non-breast malignancy * Active current autoimmune disease or history of autoimmune disease * Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C * Administration of other investigational medicinal product within 30 days of screening * Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Study Objectives This phase I trial is studying the side effects and best dose of bortezomib when given together with fludarabine with or without rituximab in treating patients with relapsed or refractory indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 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 fludarabine with or without rituximab may kill more cancer cells. Conditions: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hematopoietic/Lymphoid Cancer, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia Intervention / Treatment: DRUG: bortezomib, DRUG: fludarabine phosphate, BIOLOGICAL: rituximab 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: * Diagnosis of chronic lymphocytic leukemia (CLL) OR indolent non-Hodgkin's lymphoma (NHL) of any of the following subtypes: * Follicular lymphoma: * Grade I follicular small cleaved cell; * Grade II follicular mixed cell; * Grade II follicular large cell; * Diffuse small cleaved cell; * Small lymphocytic lymphoma; * Lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia) * AND * Extranodal marginal zone B-cell lymphoma (mucosa-associated lymphoid tissue [MALT] lymphoma); * Nodal marginal zone B-cell lymphoma (monocytoid B-cell lymphoma); * Splenic marginal zone lymphoma (splenic lymphoma with villous lymphocytes); * Mantle cell lymphoma: * No blastic phase mantle cell lymphoma * Relapsed or refractory, progressive disease: * First, second, or third relapse * Measurable disease, meeting 1 of the following criteria: * At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan (for NHL patients); * OR: * Lymphocytosis > 50,000/mm3 OR evidence of progressive bone marrow infiltration failure (e.g., hemoglobin 10 g/dL) OR thrombocytopenia (i.e., platelet count < 100,000/mm3) with > 30% infiltration of bone marrow by leukemia (for CLL patients) * No measurable lymphadenopathy (for CLL and Waldenstrom's macroglobulinemia patients) * No evidence of CNS lymphoma * Performance status: * ECOG 0-2 * Life expectancy: * More than 12 weeks * No history of uncontrolled orthostatic hypotension * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No uncontrolled concurrent illness * No grade 2 or greater neuropathy * No history of allergy or anaphylaxis to mannitol, bortezomib, fludarabine, or boron * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * At least 4 weeks since prior monoclonal antibody (MoAB) therapy: * Patients who have received MoAB therapy within the past 3 months must have documented disease progression since receiving this therapy * No prior allogeneic stem cell transplantation * More than 4 weeks since prior chemotherapy * Prior fludarabine allowed * At least 1 week since prior steroids * At least 3 months since prior radio-immunotherapy * More than 4 weeks since prior radiotherapy * No prior bortezomib * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 75,000/mm3 (greater than 50,000/mm3 if lymphomatous bone marrow involvement is present) * Bilirubin no greater than 2.0 mg/dL * AST/ALT no greater than 4 times normal * Creatinine clearance greater than 40 mL/min * No other concurrent investigational agents or treatments for the malignancy * No brain metastases * OR: Quantitation of IgM paraprotein (for Waldenstrom's macroglobulinemia patients)

Study Objectives To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules. Conditions: Sarcoma, Kaposi, HIV Infections Intervention / Treatment: DRUG: Tecogalan sodium Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT

Inclusion Criteria Patients must have: * Kaposi's sarcoma plus HIV infection OR metastatic solid tumor. * Life expectancy of at least 12 weeks. * NO symptomatic AIDS-defining opportunistic infection within the past 4 weeks. * Recovered from toxicity of any prior anticancer therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Leukemia or lymphoma. * Current gastrointestinal bleeding by stool guaiac. * Extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors. * Active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics. * Acute intercurrent infection other than genital herpes. * Symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy. Concurrent Medication: Excluded: * Other anticancer therapy. * Other investigational agents. Patients with the following prior conditions are excluded: * History of acute or chronic gastrointestinal bleeding or inflammatory bowel disease. * History of myocardial infarction within past 6 months. Prior Medication: Excluded: * Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C). * Investigational agents within the past 4 weeks.

Study Objectives This phase II trial studies how well olaparib works in treating patients with stage IV pancreatic cancer. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Metastatic Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v6 and v7 Intervention / Treatment: DRUG: Olaparib 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 with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas * Family history: one or more close blood relative with ovarian carcinoma at any age or breast cancer age 50 or younger or two relatives with breast, pancreatic or prostate cancer (Gleason 7 or higher) at any age, or patients with Ashkenazi Jewish ancestry; however, patients with previously identified genetic aberrations that are associated with homologous recombination deficiency (HRD) will be eligible even in the absence of family history (e.g. somatic BRCA mutation, Fanconi anemia gene, ATM or RAD51 mutations) * Patients must be germline BRCA 1 or 2 negative; (Note: if BRCA status was previously determined, that result is acceptable but documentation of status must be available; subjects with unknown status will be referred to genetic counselling for BRCA testing as per standard of care) and/or patients with previously identified genetic aberrations that are associated with HRD will be eligible even in the absence of family history (e.g. somatic BRCA mutation, Fanconi Anemia gene, ATM or RAD51 mutations) * Patients must have received at least one prior therapy for metastatic disease to be eligible * 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 * All treated patients have the option to undergo pre-treatment biopsy (liver, omentum, lung or lymph node) to be eligible * Patients with prior malignancy and treated with no evidence of active disease, and more than 2 years from initial diagnosis are eligible * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky > 70) * Leukocytes >= 3,000 cells/mm^3 * Absolute neutrophil count >= 1,500 cells/mm^3 * Platelets >= 75,000 cells/mm^3 * Hemoglobin >= 9 g/dl (no blood transfusions within 4 weeks prior to enrollment) * Total bilirubin < 1.5 x institutional upper limit of normal (IULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x IULN without liver metastasis; =< 5 x IULN for patients with liver metastasis * Creatinine not greater than upper institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal * International normalized ratio (INR) < 1.5 * Women of childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) and fertile men must agree to use two highly effective forms of contraception while they are receiving study treatment and for 30 days after last dose of study drug; male subjects must agree to refrain from sperm donation during the study and for 30 days after the last dose of study drugs * Ability to understand and the willingness to sign a written informed consent document; signed informed consent form must be obtained prior to initiation of study evaluations and/or activities Exclusion Criteria: * Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia and myocardial infarction (MI) within 3 months of initiation of therapy * Patients whose tumors are deemed to be platinum-refractory will be excluded from the trial * Pregnancy or lactation * Patient has active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy * Patient has undergone major surgical resection within 4 weeks prior to enrollment * Patient received radiotherapy, surgery, chemotherapy, or an investigational therapy within 2 weeks prior to study entry * Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug * Serious psychiatric or medical conditions that could interfere with treatment * Major bleeding in the last 4 weeks prior to study entry * Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors * Resting electrocardiogram (ECG) with corrected QT interval (QTc) > 470 msec (Fridericia's scale)

Study Objectives Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed daily combined with Cyclophosphamide and Doxorubicin in cancer patients Conditions: Cancer Intervention / Treatment: DRUG: Nexavar (Sorafenib, BAY43-9006) Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * At least 18 years old * Advanced histological or cytological documentation of cancer * life-expectancy of at least 12 weeks * able to swallow pills * ECOG status of 0,1 or 2 * adequate bone marrow * liver and renal function Exclusion Criteria: * > NYHA Class 2 CHF * Serious myocardial dysfunction, * or symptomatic coronary artery disease (MI more than 6 months prior to study entry is allowed) * History of organ allograft * uncontrolled hypertension * renal dialysis * Bleeding event/hemorrhage within 4 weeks of study treatment * major surgery within 4 weeks of study treatment * Previous exposure to doxorubicin or other anthracyclines exceeding a maximum lifetime cumulative dose

Study Objectives Single center, open label, phase I-II, non-randomized, two-cohort, repeated single dose study to explore the feasibility, efficacy, safety, and Overall Response Rate (ORR) of oxaliplatin, or cisplatin and doxorubicin when given as a pressurized intraperitoneal chemotherapy (PIPAC) to patients (men and women) with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and in primary cancers of peritoneum. Conditions: Peritoneal Carcinomatosis Intervention / Treatment: DRUG: Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) fixed repeated dose, DRUG: Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) increasing single dose Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Clinical and pathological confirmation of peritoneal carcinomatosis from gastric, colorectal and ovarian cancers or primary peritoneal tumors. * Patients aged between 18 and 78 years. * Performance status sec. ECOG <= 2 * Disease progression/relapse after at least one line of previous i.v. standard chemotherapy in gastric cancer and primary peritoneal tumors and two lines in colorectal and ovarian cancers. * Patients with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and primary peritoneal cancers not eligible to cytoreductive surgery +/- HIPEC. * Blood and electrolyte counts, liver, renal and cardiopulmonary function parameters within 10% of the normal range. * Written informed consent. * Tumor mass present on CT-scan in order to allow tumor response assessment with RECIST-criteria. Exclusion Criteria: * Extra-abdominal metastatic disease, with the exception of isolated pleural carcinomatosis. * Bowel obstruction. * Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias. * Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system. * Creatinine clearance < 60 ml /min. * Pregnancy. * Previous treatment reaching the maximum cumulative dose of doxorubicin, daunorubicin, epirubicin, idarubicin and/or other anthracyclines and anthracenediones. * Known allergy to cisplatin or other platinum-containing compounds or to doxorubicin. * Patients of both sexes who do not conduct complete abstinence from heterosexual relationships or agree to use an effective clinically acceptable method (with failure rate <1%) during the study and the following 6 months after the last treatment.

Study Objectives According to amendment 3 this study addresses the question if intensification of administration of rituximab in standard treatment for patients with newly diagnosed aggressive B-Non Hodgkin Lymphoma (B-NHL) and high risk (aaIPI 2 or 3) results in a better time to treatment failure (TTTF) Conditions: Non-Hodgkin's Lymphoma (NHL) Intervention / Treatment: DRUG: R-CHOEP 14 with 12x Rituximab Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * 18-60 years of age * Risk group International Prognostic Index (IPI) 2 and 3 (age adjusted) * Performance status: Eastern Cooperative Oncology Group (ECOG) 0-3 * Patient's written informed consent * Aggressive non-Hodgkin's lymphoma with CD20+ histology Exclusion Criteria: * Already initiated lymphoma therapy * Serious accompanying disorder or impaired organ function * Bone marrow involvement > 25% * Known hypersensibility to the medications to be used * Known HIV-positivity * Active hepatitis infection * Suspicion that patient compliance will be poor * Simultaneous participation in other trials * Prior chemo- or radiotherapy for previous disorder * Other concomitant tumour disease

Study Objectives The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment. Conditions: Actinic Keratosis Intervention / Treatment: DRUG: LEO 43204 gel, DRUG: Vehicle gel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2) * Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 In2). The tracking area must be within the treatment area Exclusion Criteria: * Location of the treatment area (full balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC * Treatment with ingenol mebutate gel in the treatment area within the last 12 months * Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions) * History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)

Study Objectives This phase Ib study includes two phases: dose escalation phase and safety expansion phase. During the dose escalation phase, successive cohorts of eligible patients (minimum 3 and maximum 6 evaluable patients per cohort) will receive increasing oral doses of LDE225 administered on a continuous once daily (QD) dose in combination of gemcitabine. This phase of the study will determine the maximum tolerated dose (MTD) and/ or recommended dose for expansion (RDE) of LDE225 administered in combination with gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma patients. During the safety expansion phase, once the MTD of LDE225 is established, additional patients will be enrolled and treated at the MTD of LDE225 in combination with gemcitabine in order to further evaluate its safety, tolerability and explore the potential efficacy of the combined treatments on the patients in locally advanced or metastatic pancreatic adenocarcinoma. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: LDE225+gemcitabine Location: United States, Spain, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with locally advanced or metastatic pancreatic adenocarcinoma that have not been previously treated or have progressed despite chemotherapy * Performance status of 0 or 1 per WHO classification * Adequate hematologic , renal and liver function * Adequate blood creatine kinase value (CK < 1.5ULN) Exclusion Criteria: * Treatment with prior radiotherapy * Pancreatic cancer that is potentially curable by surgery * Women of childbearing potential unless they are using highly effective method of contraception Other protocol-defined inclusion/exclusion criteria may apply Other protocol-defined inclusion/exclusion criteria may apply.

Study Objectives The primary objective of this study is to determine if estrogen receptor-targeted therapy with fulvestrant used in combination with Everolimus is an effective and safe therapy for women with hormone receptor positive metastatic breast cancer after failure of aromatase inhibitor therapy. Conditions: Breast Cancer Intervention / Treatment: DRUG: Everolimus, DRUG: Fulvestrant 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: * Postmenopausal status, defined as any one of the following criteria: Documented history of bilateral oophorectomy, Age 60 years or more, OR Age 45 to 59 and satisfying one or more of the following criteria: Amenorrhea for at least 12 months and intact uterus OR Amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) concentration - within postmenopausal range including: Patients who have had a hysterectomy or Patients who have received hormone replacement * Patients must have histologically confirmed invasive breast cancer * Metastatic or locally advanced disease * Patients must have estrogen receptor and/or progesterone receptor positive disease * Measurable or evaluable disease * Failure of aromatase inhibitor therapy within the previous 6 months. Patients who received prior tamoxifen are eligible to enroll * Prior aromatase inhibitor therapy or other endocrine therapy must be discontinued at least 1 week prior to enrollment and any toxicity from such therapy must have reverted to grade I or less at the time of enrollment * Patients must not have received chemotherapy, radiation therapy, or had surgery within 4 weeks prior to enrollment and any toxicity from such therapy must have recovered to grade 1 or less prior to enrollment * Patients must not have received either of the study medications previously * WHO performance status of 0, 1, or 2 * Adequate organ function defined as follows: Adequate renal function, defined by a serum creatinine within the upper limits of normal, Adequate liver function, defined by a bilirubin of < 1.5 the upper limit of normal (ULN) and aspartate aminotransferase (AST), alanine aminotransferase (ALT) of <= 2.5 times the ULN, Adequate bone marrow function, defined as an absolute neutrophil count (ANC) >= 1.5 x 109/L, platelet count (PLT) >100,000/ul, Hb >9 gm/dl, international normalized ratio (INR) <1.3, and because fulvestrant is administered intramuscularly, it should not be used in patients with bleeding diatheses, thrombocytopenia or in patients on anticoagulants * Patients will be asked to provide a tumor paraffin block if available * Ability to understand and sign a written informed consent for participation in the trial Exclusion Criteria: * Known severe hypersensitivity to everolimus (or similar drugs) or any of the excipients of this product * Premenopausal status * Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ * Patients with brain metastasis or leptomeningeal involvement * Patients with malignant pleural effusion or ascites only disease * Rapidly progressive visceral disease * WHO performance status of 3 or 4 * As judged by the investigator, uncontrolled intercurrent illness including, but not limited to: Ongoing or active infection, Symptomatic congestive heart failure, Unstable angina pectoris or significant cardiac arrhythmia, Psychiatric illness/social situations that would limit compliance with study requirements, Severely impaired lung function such as severe chronic obstructive pulmonary disease (COPD) or interstitial lung disease, a known forced expiratory volume at one second (FEV1) of < 1.5 liters, or dyspnea of grade III or greater, Uncontrolled diabetes as defined by a fasting blood sugar (FBS) of > 1.5 ULM, Known liver disease such as cirrhosis or chronic hepatitis, Known HIV positivity, OR known condition causing malabsorption * Chronic treatment with systemic steroids or other immunosuppressive agents * Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial * Prior treatment with an mTOR inhibitor * Treatment with a non-approved or investigational drug within 30 days or 5 half-lives of the drug, whichever is greater, before Day 1 of study treatment * In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections * History of hypersensitivity to castor oil

Study Objectives The purpose of this study is to explore how this cancer is affected by a new medication, cetuximab. Cetuximab is directed towards a protein called EGFR (epidermal growth factor receptor), that is found in some types of cancer. Studies have shown that this drug can be beneficial in patients with colon cancer and has been approved by the US Food and Drug Administration (FDA) for this purpose. The researchers are conducting a study to see if it is beneficial in patients with sarcoma. Conditions: Sarcoma Intervention / Treatment: DRUG: Cetuximab, DRUG: Cetuximab 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: To be eligible for the study, patients must fulfill all of the following criteria: * Patients must have the ability to give informed consent and have signed an approved informed consent form. * Patients must have a pathologic diagnosis of soft tissue sarcoma or bony sarcoma. * Patients with tumor tissue available for assessment of EGFR status performed by immunohistochemistry (IHC). * Patients with Zubrod performance status 0-2. * Patients must be 16 years of age or older. * Patients, >= 16 years, must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. * If patients are childbearing or have child-fathering potential, they must use barrier contraception during intercourse while being treated on this study. * Bone marrow function: absolute neutrophil count (ANC) 1,000/ul; platelets 75,000/l. * Renal function: creatinine 2.0 x institutional upper limit of normal (ULN). * Hepatic function: bilirubin 2.5 x ULN; AST 5.0 x ULN. * Patients must have received at least one systemic chemotherapy treatment or else refuse to be treated with cytotoxic therapy. * Twenty-eight days or more should have elapsed since the patient has received any prior systemic therapy. * Patients must have documented symptomatic or radiologic progression to their preceding therapy. * For patients treated with prior radiation, 21 days or more should have elapsed since the administration of the last fraction of radiation therapy and patients must have recovered from all associated toxicities. * Patients must have measurable disease. The measurable lesion should be outside previously irradiated fields or have documented progression at least 6 weeks after completion of radiation. Exclusion Criteria: Any of the following criteria will make the patient ineligible to participate in this study: * Acute hepatitis or known HIV. * Active or uncontrolled infection. * Significant history of uncontrolled cardiac disease i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction. * Prior therapy which specifically and directly targets the EGFR pathway. * Prior severe infusion reaction to a monoclonal antibody. * Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s). * Other active systemic malignancy within the past year.

Study Objectives Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. This phase II trial is studying how well imatinib mesylate works in treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal junction cancer. Conditions: Recurrent Gastric Cancer, Stage IV Gastric Cancer Intervention / Treatment: DRUG: imatinib mesylate, 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 with metastatic and/or unresectable carcinoma of the stomach, who have measurable disease * Life expectancy > 3 months * Karnofsky Performance Status > 60% * Absence of an active infection * Granulocyte count of > 1,500/mm^3 * Hemoglobin (Hgb) >= 9 mg/dl * Serum bilirubin =< 1.5 mg/dl, regardless of liver involvement secondary to tumor * Platelets > 100,000/mm^3 * Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 x the institutional upper limit of normal * Calculated creatinine clearance of > 60 ml/min * Patients must have signed written informed consent * Female patients of child-bearing potential must have a negative blood or urine pregnancy test within two weeks prior to initial study treatment * Patients who have had prior chemotherapy or radiation therapy must have recovered from any toxicities prior to study entry * Patients must have radiographic imaging to document measurable disease within 28 days prior to initial study therapy Exclusion Criteria: * Diagnosis of resectable carcinoma of the stomach * Major surgery within four weeks of study entry * Brain metastasis or known seizure disorder * Fertile men and women not using an acceptable method of contraception * Pregnant or lactating patients are excluded since STI571 may be harmful to the developing fetus and child * Patients known to be HIV positive and receiving HAART are excluded because of possibly pharmacological interactions * Active peptic ulceration or active gastrointestinal bleeding or any active bleeding disorders * Use of therapeutic doses of coumadin (warfarin) as anticoagulation * Medical, social, or psychological factors which would prevent the patient from completing the treatment protocol * Patients with serious intercurrent illness which would preclude tolerance and completion of the protocol treatment

Study Objectives Objective: To evaluate potential benefits of adding the active form of Coenzyme Q10 (Ubiquinol) to Clomiphene Citrate compared with Human Menopausal Gonadotropins (hMG) in Clomiphene Citrate resistant PCOS patients. Methods: 148 PCOS Patients with Clomiphene Citrate resistance were randomized into two groups (A and B). In group A, controlled ovarian stimulation was done by Clomiphene Citrate 150 mg daily (from 2nd till 6th day of cycle) together with Ubiquinol starting from 2nd day till day of hCG triggering in a dose of 100 mg orally once daily. In group B, hMG was given from 2nd day of the cycle in a dose ranging from 75 to 225 IU. Serial transvaginal ultrasonography was done starting on cycle day 8 and continued till size of leading follicle reaches 18 mm or more then ovulation triggering was done. Thereafter, patients were advised for a timed intercourse (TI) after 36 hours. A blood sample was withdrawn seven days after hCG triggering, for measurement of serum progesterone. If the Patient presented with a missed period for one week, a serum sample was sent for β-hCG. Conditions: Polycystic Ovarian Syndrome Intervention / Treatment: DRUG: Controlled ovarian stimulation by Combined Clomiphene Citrate and Ubiquinol Versus hMG Location: Saudi Arabia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: Patients with Clomiphene Citrate resistant PCOS who fulfilled the following inclusion criteria: * Age 18 to 35 years * Body mass index (BMI) between 18.5 and 34.9 kg/m2 * Presenting with primary or secondary infertility. PCOS was diagnosed according to the Rotterdam ESHRE/ASRM Consensus workshop, with at least 2 of the following 3 criteria: A- Oligo- and/or anovulation; manifested by oligomenorrhea or amenorrhea. Oligomenorrhea was defined as cycle interval of more than 35 days but less than six months. Amenorrhea was defined as absence of menstruation for six months or more. B- Hyperandrogenism; biochemical and/or clinical in the form of acne or hirsutism defined as a score of 8 or higher using the modified Ferriman-Gallwey scoring system when abnormal hair distribution was assessed in nine body areas and given a score of 0 to 4. C - Polycystic ovarian morphology detected by transvaginal ultrasound with the presence of 12 or more follicles measuring 2-9 mm in diameter in one or both ovaries, and/or increased ovarian volume >10 mL. * Clomiphene Citrate resistance was defined as failure of ovulation after administration of Clomiphene Citrate in a dose of 150 mg for 5 days per cycle, for two or three cycles. * Patent both fallopian tubes and normal uterine cavity as evidenced by hysterosalpingography (HSG). * Their partners had normal semen parameters as defined by the modified WHO 2010 criteria. Exclusion criteria were: * Morbidly obese patients with BMI >=35 Kg/2m. * Abnormal husband semen analysis. * Abnormal HSG or laparoscopic evidence of pelvic adhesions. * Patients receiving statin drugs for cholesterol, beta-blockers for high blood pressure, or tricyclic antidepressants, were also excluded as these drugs can lower the levels of ubiquinol in the body.

Study Objectives This phase I trial is studying the side effects and best dose of R(+)XK469 in treating patients with advanced neuroblastoma. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Conditions: Disseminated Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma Intervention / Treatment: DRUG: R(+)XK469 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: * Histologically confirmed high-risk neuroblastoma that has relapsed or is refractory to standard therapy * No active brain metastases * Previously treated brain metastases allowed if there is no requirement for corticosteroids or anticonvulsants * Performance status - Karnofsky performance status 70-100% or Lansky score >= 70 for your pediatric patients * More than 3 months * WBC at least 3,000/mm^3 * Absolute neutrophil count at least 1,500/mm^3 * Platelet count at least 100,000/mm^3 * Bilirubin normal (unless due to documented Gilbert's syndrome) * Creatinine less than 1.5 times upper limit of normal * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent uncontrolled illness that would preclude study participation * No ongoing or active infection * No psychiatric illness or social situation that would preclude study participation * No prior allergic reaction to compounds of similar chemical or biological composition to study drug (e.g., flurbiprofen or ibuprofen) * No HIV-positive patients * No concurrent biologic agents * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) * No other concurrent chemotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent palliative radiotherapy * See Disease Characteristics * Recovered from all prior therapy * No other concurrent investigational agents * No concurrent commercial agents or therapies directed at malignancy * No concurrent combination anti-retroviral therapy for HIV-positive patients

Study Objectives The primary purpose of the study is to estimate the time from the first dose of LY573636-sodium (hereafter referred to as LY573636) to the date your physician determines that your disease has progressed or worsened. Conditions: Sarcoma, Soft Tissue Intervention / Treatment: DRUG: LY573636-sodium Location: United States, Argentina, Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosis of soft tissue sarcoma that is unresectable or metastatic * Have received one or two (but no more than two) prior treatment regimens for metastatic soft tissue sarcoma, one of which must have included doxorubicin (adriamycin). * Must have stopped all previous treatments for cancer, including chemotherapy, radiation therapy or other investigational treatments for cancer for at least 30 days Exclusion Criteria: * Participants with primary bone sarcoma (for example osteosarcoma, Ewing's sarcoma, chondrosarcoma), gastrointestinal stromal tumor (GIST) and Kaposi's sarcoma * Serious pre-existing medical problems (as determined by your doctor) * Have received more than two previous systemic treatment regimens for unresectable or metastatic soft tissue sarcoma * Have a second primary cancer (unless cancer-free for more than 2 years) * Active treatment with Warfarin (Coumadin)

Study Objectives This study will compare a web-based advance directive to a standard advance directive. Conditions: GI Cancer, Thoracic Cancer Intervention / Treatment: OTHER: Web platform for advance care planning/advance directive, OTHER: Standard advance directive Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria (any of the following) * Pancreatic cancer, any stage except stage 0 (C25), * NSCLC, stage IIIA or higher (C34), * SCLC, any stage (C34), * Colon cancer, stage IIIB or greater (C18), * Rectal cancer, stage IIB or greater (C21), * Esophageal cancer (adeno or squamous), any stage (C15), * Stomach cancer, stage IIB or greater (C16), * Gallbladder cancer, stage I or greater (C23), * Cholangiocarcinoma, any stage (C22.1), * HCC, any stage (no plan for transplant) (C22.0), * Malignant carcinoid of GI tract, stage IV (C7A.019). Exclusion criteria: * Does not have an active patient portal (MyPennMedicine) account, * Does not use email at least once per month, * Has already completed a living will, * Does not speak fluent English, * Unwilling to be contacted by email, * Determined to be too ill or inappropriate for participation by patient's oncologist.

Study Objectives This phase II trial studies how well an umbilical cord blood transplant with added sugar works with chemotherapy and radiation therapy in treating patients with leukemia or lymphoma. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The umbilical cord blood cells will be grown ("expanded") on a special layer of cells collected from the bone marrow of healthy volunteers in a laboratory. A type of sugar will also be added to the cells in the laboratory that may help the transplant to "take" faster. Conditions: Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia, Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Chemotherapy-Related Leukemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia, Hodgkin Lymphoma, Langerhans Cell Histiocytosis, Minimal Residual Disease, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts, Non-Hodgkin Lymphoma, Recurrent Hodgkin Lymphoma, Refractory Acute Lymphoblastic Leukemia, Refractory Myelodysplastic Syndrome, Small Lymphocytic Lymphoma, Therapy-Related Myelodysplastic Syndrome Intervention / Treatment: BIOLOGICAL: Anti-Thymocyte Globulin, DRUG: Busulfan, DRUG: Clofarabine, DRUG: Cyclophosphamide, BIOLOGICAL: Filgrastim-sndz, DRUG: Fludarabine, DRUG: Melphalan, DRUG: Mycophenolate Mofetil, BIOLOGICAL: Rituximab, DRUG: Tacrolimus, RADIATION: Total-Body Irradiation, PROCEDURE: Umbilical Cord Blood Transplantation 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 one of the following hematologic malignancies: a. 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 myelodysplastic syndrome (MDS), Langerhan's cell histiocytosis, any disease beyond first remission. b. Myelodysplastic syndrome (MDS): MDS International Prognostic Scoring System (IPSS) INT-1 will be enrolled only if the subjects have failed previous leukemia treatments and are transfusion-dependent. MDS may be primary or therapy related, including patients that will be considered for transplant. Including the following categories: 1) Revised IPSS intermediate and high risk groups, 2) MDS with transfusion dependency, 3) Failure to respond or progression of disease on hypomethylating agents, 4) Refractory anemia with excess of blasts, 5) Transformation to acute leukemia, 6) Chronic myelomonocytic leukemia, 7) Atypical MDS/myeloproliferative syndromes, 8) Complex karyotype, abn(3g), -5/5g-, -7/7g-, abn(12p), abn(17p). c. Acute lymphoblastic leukemia (ALL) patients with the following will be considered: 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. 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 which excludes > 7 chromosomal abnormalities, or double hit non-Hodgkin's lymphoma. Non-Hodgkin's lymphoma (NHL) in second or third complete remission or relapse (including relapse post autologous hematopoietic stem cell transplant), or relapsed double hit lymphoma. Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with progressive disease with progression after standard of care therapy or have failed/been intolerant to ibrutinib. Chronic myelogenous leukemia (CML) second chronic phase or accelerated phase. Hodgkin's disease (HD): Induction failure after the first complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant), or those with active disease. * The first 6 patients must be >= 18 and =< 65 years old. The subsequent patients may include pediatric patients >= 12 and =< 65 years old. Eligibility for pediatric patients will be determined in conjunction with an MD Anderson Cancer Center (MDACC) pediatrician. * Performance score of at least 80% by Karnofsky or performance score (PS) < 3 (Eastern Cooperative Oncology Group [ECOG]) (age >= 12 years) * Left ventricular ejection fraction of > 40%. * Pulmonary function test (PFT) demonstrating a diffusion capacity of least 50% predicted. * Creatinine =< 1.5 mg/dL for patients 12 years old and older and =< 1 for patients younger than 12 years old. * Serum glutamate pyruvate transaminase (SGPT) =< to 2.0 x normal. * Bilirubin =< to 2.0 x normal. * Negative beta human chorionic gonadotropin (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. * Patients must have two cord blood (CB) 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 1.5 x 10^7 total nucleated cells/Kg recipient body weight (pre-thaw). * Have identified a backup cells source in case of engraftment failure. The source can be autologous, related or unrelated. * Patient must not have a 10/10 HLA matched family member or unrelated donor. * Patients will have a back-up graft from any of the following: an available fraction of autologous marrow; or peripheral blood progenitor cells (PBPCs) harvested and cryopreserved; or family member donor; or a third cord blood unit. * Prior to initiating chemotherapy in this study, twenty-one or more days must have elapsed since the patient's last radiation or chemotherapy administration (Hydrea, Gleevec and other tyrosine kinase inhibitors [TKI] as well as intrathecal therapy are accepted exceptions). Exclusion Criteria: * Patients with known history of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). * Patients with positive hepatitis serology that is definitive of active disease. * Active central nervous system (CNS) disease in patient with history of CNS malignancy. * Patients with chronic active hepatitis or cirrhosis. If positive hepatitis serology, the study chair may deem the patient eligible based on the results of liver biopsy. * Patients with 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. * 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. * Pediatric patients with acute lymphoblastic leukemia (ALL) that is t (9,22) positive in first remission are not eligible unless there is evidence of minimal residual disease after initial induction and/or consolidation treatment or the pediatric Philadelphia chromosome positive (Ph+) ALL is clinically refractory to available therapies with evidence of persistence in the bone marrow or peripheral blood. * Patients with options for treatment that are known to be curative are not eligible.

Study Objectives The goal of this clinical research study is to learn if the level of nitric oxide you breathe out may relate to the amount of breathing complications that you may experience due to radiation treatment. Conditions: Lung Cancer Intervention / Treatment: PROCEDURE: Nitric oxide breath test, BEHAVIORAL: Questionnaires Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients will sign consent for the study. * Patients with pathologic diagnosis of esophagus or lung cancer. * Patient plans to receive radiation treatment at MD Anderson. * Patient will receive >= 5 weeks of thoracic radiotherapy. * Patients >= 18 years of age. Exclusion Criteria: * Patients who have asthma. * Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months [i.e., who has had menses at any time in the preceding 24 consecutive months]) must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide) throughout the study.

Study Objectives This is a research study to test the effectiveness of nab-paclitaxel + carboplatin + MPDL3280A for treatment of non-small-cell lung carcinoma (NSCLC), which is a type of lung cancer. The study aims to determine if chemotherapy combined with immune-based therapy can lead to improvement in tumor response rates over historical response rates with chemotherapy alone. Conditions: Carcinoma, Non-Small-Cell Lung Intervention / Treatment: DRUG: MPDL3280A, DRUG: Carboplatin, DRUG: Nab-paclitaxel 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 pathologically confirmed non-small cell lung cancer, of either squamous or non-squamous histology. * Stage 1B-3A * Deemed surgically resectable by a thoracic surgeon * Age >= 18 years * Radiologically measurable disease, as defined by response evaluation criteria in solid tumours (RECIST) v1.1 * Ability to understand and the willingness to sign a written informed consent document * Females of child-bearing potential must: * Either commit to true abstinence from heterosexual contact, or agree to use, and be able to comply with, effective contraception (<=1% failure rate annually) without interruption, 28 days prior to starting therapy (including dose interruptions), and while on study medication or for a period of 90 days following treatment completion. * Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. * Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following treatment discontinuation, even if he has undergone a successful vasectomy. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 10 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression * Tumor tissue should be of good quality based on total and viable tumor content. * Patients who do not have tissue specimens meeting eligibility requirements may undergo a biopsy during the screening period. * Adequate organ and marrow function as defined below: * Lymphocyte count >=300/microliter (mcL) * Neutrophil count >=1,500/mcL * Hemoglobin >=9.0g/dl * Platelets >=100,000/mcL * Total bilirubin <=1.5 x institutional upper limit of normal (ULN) (*Patients with Gilbert's disease: <=3 x ULN) * Aspartate aminotransferase (AST)(SGOT)/alanine aminotransferase (ALT)(SGPT) <=2.5 × ULN * Alkaline phosphatase <=2.5 x ULN * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) <= 1.5 x ULN (*Unless the patient is on therapeutic anticoagulation) * Serum creatinine <=1.5 x ULN or * Creatinine clearance >=50 mL/min/1.73 m2 by Cockcroft-Gault estimation Exclusion Criteria: * Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 5 years prior to initiation of study treatment; however, the following are allowed: * Hormone-replacement therapy or oral contraceptives * Herbal therapy > 1 week prior to Cycle 1, Day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to Cycle 1, Day 1) * Malignancies other than the disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score <= 6, and prostate-specific antigen (PSA) <= 10 mg/mL, etc.) * Patients who are receiving any other investigational agents concurrently. * Patients with no smoking history * History of allergic reactions attributed to compounds of similar chemical or biologic composition to MPDL3280A, carboplatin, or paclitaxel. * Patients with active hepatitis B or C infections or a history of HIV infection. * Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen (HBsAg) test and a positive for the antibody test to detect antibodies to hepatitis B core antigen (anti-HBc) are eligible. * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection including tuberculosis (TB), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease * Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * 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, Sjögren's syndrome, Bell's palsy, Guillain-Barré 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 are permitted provided that they meet the following conditions: * Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations * Rash must cover less than 10% of body surface area (BSA) * Disease is well controlled at baseline and only requiring low potency topical steroids * 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) * Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia * Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible * Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study * Patients must not have >= Grade 2 pre-existing peripheral neuropathy (per CTCAE) * Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live, attenuated vaccine will be required during the study * Pregnant women * History of interstitial lung disease or pneumonitis of any cause Immunotherapy-Related Exclusion Criteria: * Prior treatment with anti-PD-1, anti-CTLA-4 (cytotoxic T lymphocyte-associated antigen (CTLA-4)), or anti-PD-L1 therapeutic antibody or pathway-targeting agents * Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents) within 2 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. * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. * Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.

Study Objectives This is a randomized, 2-arm phase II, multi-center study to evaluate the overall response rate in newly diagnosed, transplant ineligible patients receiving 9 cycles induction therapy with either KTd or KRd followed by randomization to either carfilzomib maintenance treatment for 12 months or to observation only. Maintenance is given for 12 cycles or progression of disease, whatever occurs first. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Carfilzomib, DRUG: Thalidomide, DRUG: Lenalidomide, DRUG: Dexamethasone Location: Germany, Austria Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Able to provide written informed consent in accordance with federal, local, and institutional guidelines * newly diagnosed, symptomatic multiple myeloma * Transplant-ineligibility: age > 65 years or patients not eligible due to comorbidities determined by investigator or patients not willing to undergo autologous stem-cell transplantation (ASCT) on personal preference * Measurable disease, as defined by one or more of the following (assessed within 21 days prior to randomization): * Serum M-protein >= 0.5 g/dL, or * Urine M-protein >= 200 mg/24 hours, or * In subjects without detectable serum or urine M-protein, serum-free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal κ/λ ratio * No prior treatment for multiple myeloma * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1 * Patients at cardiac risk (NYHA >II or pre-existing coronary heart disease or any other relevant cardiac complication) should be scheduled for a baseline echocardiography (ECHO) and can only be included if the left ventricular ejection fraction (LVEF) is >=40%); independent of cardiac risk ECG has to be done for inclusion of Asian patients and patients > 75 years of age * Adequate organ and bone marrow function within the 21 days prior to randomization defined by: * Bilirubin < 2 times the upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN * growth factor support for max 3 days allowed to achieve an absolute neutrophil count (ANC) >= 1000/mm3 (screening ANC should be of required) * Hemoglobin >= 7.0 g/dL; use of erythropoietic stimulating factors and red blood cell (RBC) transfusion per institutional guidelines is allowed, however the most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin. * Platelet count >= 30,000/mm3 * Calculated or measured creatinine clearance (CrCl) of >= 30 mL/min. Calculation should be based on the Cockcroft and Gault formula: [(140 - Age) ∙ Mass (kg) / (72 ∙ Creatinine mg/dL)]; multiply result by 0.85 if female * Females of childbearing potential (FCBP) must have a confirmed negative serum pregnancy test within the 21 days prior to randomization (performed at a central laboratory). * Females of childbearing potential and male subjects who are sexually active with FCBP must agree to use effective concomitant method(s) of contraception during the study and for 30 days (women) and 90 days (men) following the last study drug treatment administration. Exclusion Criteria: * ECOG >=2 * Frail patients * Waldenström macroglobulinemia * POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential) * Myelodysplastic syndrome * Smoldering myeloma and monoclonal gammopathy of undetermined significance (MGUS) * Second malignancy within the past 5 years except: * Adequately treated basal cell or squamous cell skin cancer * Carcinoma in situ of the cervix * Prostate cancer <= Gleason score 6 with stable prostate-specific antigen (PSA over 12 months * Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins) * Treated medullary or papillary thyroid cancer * Similar condition with an expectation of > 95% five-year disease-free survival * History of or current amyloidosis * Immunotherapy within the 21 days prior to randomization * Glucocorticoid therapy within the 14 days prior to randomization that exceeds accumulative dose of 160 mg dexamethasone or 1000 mg prednisone * Extended field radio therapy (more than 3 fields) within the 21 days prior to randomization * Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib) or any other component of formulation * Contraindication to dexamethasone, thalidomide or lenalidomide or any of the required concomitant drugs, supportive treatments or antiviral drugs, also including contraindication or hypersensitivity to any other components of these drugs (eg. hereditary galactose intolerance, complete lactase deficiency or glucose-galactose malabsorbtion in case of excipient lactose) * Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease, or myocardial infarction within 4 months prior to enrollment * Active infection within the 14 days prior to randomization requiring systemic antibiotics and/or antiviral therapy * Pleural effusions requiring thoracentesis within the 14 days prior to randomization * Ascites requiring paracentesis within the 14 days prior to randomization * Uncontrolled hypertension or uncontrolled diabetes despite medication * Significant neuropathy (Grade 2 with pain or Grade 3 or higher) within the 14 days prior to randomization * Known cirrhosis * Known human immunodeficiency virus (HIV) seropositivity, hepatitis C infection, or hepatitis B infection: subjects with past hepatitis B virus (HBV) infection or resolved HBV infection defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen (HBc) antibody test are eligible; subjects positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. * Participation in another interventional study within the 28 days prior to randomization * Major surgery (except kyphoplasty) within the 28 days prior to randomization * Female subjects who are pregnant or lactating * Any other clinically significant medical disease or social condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent, be compliant with study procedures, or provide accurate information.

Study Objectives This study involves adults receiving radiation therapy for head and neck cancer and will test whether or not the study mouthrinse may lessen oral mucositis. Conditions: Oral Mucositis Intervention / Treatment: DRUG: Neem Mouthrinse, DRUG: Placebo Mouthrinse Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Anatomic site: lip (inner aspect), oral cavity, pharynx or larynx; includes tonsils and salivary glands (ICD-9: 140-149 or 161). * Malignant tumor: ICD-O morphology 2 (in situ) or 3 (malignant, invasive or infiltrating). * Adult aged 18-89 years. * Patient recommended or planned to undergo radiotherapy to the head and neck regions, as part of their cancer treatment regimen. * Radiotherapy to be given in standard doses over a 4 - 7 week period. Exclusion Criteria: * Prior radiation treatment for cancer of the oral cavity, head or neck. * Baseline mouth and throat soreness (MTS) extreme score of 4. * Eastern Cooperative Oncology Group (ECOG) performance status >2. * Unable to sign Informed Consent. * Known history of allergy to any of the mouthrinse constituents (aloe, anise, ascorbic acid, clove, glycerin, peppermint, poloxamer 407, potassium sorbate, spearmint, thyme, water, xylitol). * Inability to use a mouth rinse. * Patient unable to communicate with study personnel in English (either themselves or an interpreter).

Study Objectives This prospective, post marketing, observational, Noninterventional Study (NIS) is designed to compare drug persistence in patients treated with Certolizumab Pegol (CZP) and patients treated with any other subcutaneously (sc) administered Tumor Necrosis Factor (TNF) inhibitor. Conditions: Rheumatoid Arthritis Location: Germany Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Diagnosis of Rheumatoid Arthritis (RA) * Moderate to severe disease activity of RA * The patient receives Tumor Necrosis Factor (TNF) inhibitor in combination with at least 1 synthetic Disease Modifying Antirheumatic Drug (DMARD) * The decision to prescribe a TNF inhibitor in combination with DMARD is made by the treating physician, prior to and independently from the decision to include the patient in this Non-Interventional Study (NIS) * Male or female patients >= 18 years of age, considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires) * The patient personally signed and dated Patient Data Consent Form (PDCF) prior to Visit 2 * Treatment is according to the Summary of Product Characteristics (SmPC) Exclusion Criteria: * Known contraindications to Tumor Necrosis Factor (TNF) inhibitors * Prior use of any TNF inhibitors (including Adalimumab, Etanercept, Infliximab, Certolizumab, or Golimumab), or other biologic DMARDs (including Abatacept, Rituximab, Tocilizumab, or Anakinra) * Participation in an investigational study

Study Objectives The purpose of this study is to use Sorafenib + 5-FU to evaluate activity, efficacy, safety, pharmacodynamics (PD) and pharmacokinetics (PK) in patients with advanced hepatocellular carcinoma (HCC). Conditions: Hepatocellular Carcinoma Intervention / Treatment: DRUG: Infusional 5-Fluorouracil, DRUG: Sorafenib (Bay 43-9006) Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Screening must be done within 28 days of study drug administration (laboratory evaluations must be done within 7 days). For inclusion in the study, patients must fulfill all of the following criteria: * Age 18 years. * Patients should have proven primary HCC according to one of the following criteria: * Histological evidence of HCC on a biopsy specimen. Patients with the fibrolamellar subset are excluded, as are any patients with a mixed histology. * Cytological evidence of HCC is acceptable only if tissue cannot be obtained for histological evaluation. * ECOG Performance Status of 0 or 1 * Life expectancy of at least 12 weeks at the pre-treatment evaluation. * Inoperable tumor (T2-T4, any N, M0 or M1 as defined by the TNM classification) * Patient considered by the investigator to be appropriate for systemic therapy. * Patients with at least one measurable lesion by CT-scan or MRI according to the Recist criteria, performed within 4 weeks prior to start of dosing. * Patients who have not received any systemic anti-cancer treatment for HCC such as: chemotherapy, immunotherapy, hormonal therapy, vaccines as well as any systemic agent given with antineoplastic intent, prior to study inclusion. (previous local therapy is permitted). Previous treatment with Octreotide is however allowed, provided that the administration of the drug was discontinued at least 7 days prior enrolment or at least 28 days if the LAR (long acting release) formulation of the drug was used. * Patients who have received local therapy, such as: surgery, radiation therapy, hepatic arterial embolization, chemo-embolization, radio-frequency ablation or cryo-ablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of 25% in the size. Furthermore, the local therapy applied to target or non-target lesions needs to have been completed at least 8 weeks prior to study inclusion (Lesions treated with external beam radiation therapy are not acceptable as target lesions, unless they fulfill the conditions described above). * Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: * Hemoglobin 8.5 g/dl * Absolute granulocytes 1.5 x 109/L * Platelet count 60 x 109/L * Total serum bilirubin 3 mg/dl * ALT (SGOT) and AST (SGPT) 5 x upper limit of normal * PT-INR 2.3 or PT 6 seconds above control * Serum creatinine 1.5 x upper limit of normal. * Cirrhotic status of Child's Pugh class A or B. Child's Pugh class C should be excluded * Written Informed Consent must be obtained and documented prior to any study specific procedures. Exclusion Criteria: Patients who meet the following criteria at the time of screening will be excluded; excluded medical conditions: * Congestive heart failure defined as NYHA class III or IV. * Serious cardiac arrhythmias. * Active coronary artery disease or ischemia. * Active clinically serious infections (> grade 2 NCI-CTC). * Known history of HIV infection. * Known metastatic brain or meningeal tumors. * History of seizure disorder. * History of organ allograft. * Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis & T1] or other malignancies curatively treated > 3 years prior to entry). * Patients with clinically significant gastrointestinal bleeding within the past month prior to study entry are ineligible. Excluded therapies and medications, previous and concomitant: * Any systemic anticancer treatment or any agent administered with antineoplastic intent, including chemotherapy, immunotherapy , vaccines or hormonal therapy given before study entry or during study treatment. Anticancer therapy is defined as any agent or combination of agents with clinically proven anticancer activity administered systemically, with the purpose of affecting the cancer, either directly or indirectly, including palliative and therapeutic endpoints. In certain cases, local anticancer therapy is allowed. See Inclusion Criteria for details. * Any surgical procedure within 4 weeks prior to start of study drug. * Autologous bone marrow transplant or stem cell rescue within 4 months of study entry. * Use of biologic response modifiers, such as G-CSF, within 3 weeks of study entry. G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity, such as febrile neutropenia, when clinically indicated, or at the discretion of the investigator; however, they may not be substituted for a required dose reduction. Chronic Erythropoietin treatment prior to the study entry or during the study is permitted. * Use of ritonavir and grapefruit juice. * Prior use of Raf-Kinase inhibitors, MEK or Farnesyl Transferase Inhibitors. Any investigational drug therapy outside of this trial during or within 4 weeks of study entry. Other Exclusion Criteria: * Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures (e.g. cervical cap, condom, diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between SORAFENIB and oral contraceptives. * Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patient's participation in the study or evaluation of the study results. * Known allergy to the investigational agent or any agent given in association with this trial. * Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.

Study Objectives The primary aim of this study is to investigate the possibility to replace an erythrocyte based prime solution with a crystalloid based prime solution while maintaining metabolic function. Secondary also to study if potentially reduced immunological influence is obtained during hyper thermic isolated limb perfusion with a crystalloid based prime solution. Conditions: Melanoma, Sarcoma Intervention / Treatment: DRUG: Crystalloid based prime solution, DRUG: Erythrocyte based prime solution Location: Sweden Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * The patient scheduled for treatment with isolated hyperthermic perfusion * Age over 18 years. * Signed informed consent

Study Objectives EP0057-201 is a Phase 2A/B adaptive design study. Phase 2A will test EP0057 in combination with Olaparib and Phase 2B, the randomised part of the study, will test EP0057 in combination with Olaparib against SOC chemotherapy. When EP0057 is combined with Olaparib, it is envisaged that the combination should improve therapeutic responses in the recurrent ovarian cancer disease setting. EP0057 is an investigational nanoparticle-drug conjugate administered intravenously. The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057, and therefore of the payload Camptothecin, to translate into maximum tumour cell killing. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: EP0057, DRUG: Olaparib tablets Location: United States, Hungary, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients aged >= 18 years of age at the time of Informed Consent * Ability to understand and provide written informed consent prior to undergoing any study procedures * Life expectancy of > 3 months, as estimated by the investigator * Histologically confirmed diagnosis (cytology alone excluded) with high-grade serous ovarian cancer or high-grade endometrioid ovarian cancer, including primary peritoneal or fallopian tube cancer * BRCA mutational status is known (germline and somatic). (For Patients in Phase 2A, status does not need to be known prior to enrolment) * HRD status is known. (For Patients in Phase 2A, status does not need to be known prior to enrolment) * At least 1 measurable lesion to assess response by RECIST v1.1 criteria * Archival tumour sample must be available. In the absence of an archival tumour biopsy, a tumour tissue biopsy will need to be collected prior to enrolment * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening * Normal organ and bone marrow function: Haemoglobin >= 9.0 g/dL Absolute neutrophil count (ANC) >= 1.5 x 109 Lymphocyte count >= 0.5 x 109 Platelet count >= 100 x 109 Total bilirubin <= 1.5 institutional upper limit normal (ULN) Serum albumin >= 2.5 g/dL AST and ALT <= 2.5 x ULN, unless liver metastases are present in which case they must be <= 5 x ULN Serum creatinine <= 1.5 x ULN or calculated creatinine clearance > 50 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal Patients not receiving anti-coagulant medication must have an INR of <= 1.5 and an aPTT <= 1.5 x ULN * In the opinion of the Investigator, all other relevant medical conditions must be well-managed and stable for at least 28 days prior to first administration of study drug * Willing and able to participate in all required evaluations and procedures in this study protocol * Contraception: Each female subject of childbearing potential must agree to use a highly effective method of contraception (i.e., a method with less than 1% failure rate per year [e.g., sterilization, hormone implants, hormone injections, some intrauterine devices, vasectomized partner, or combined birth control pills]) from screening until 6 months after the last dose of EP0057 or Olaparib, whichever was taken last. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative serum or urine pregnancy test within 24 hours prior to EP0057 dosing on Day 1 of each Cycle (and must not be lactating). Each female subject will be considered to be of childbearing potential unless she has been surgically sterilised by hysterectomy or bilateral tubal ligation/salpingectomy or has been postmenopausal for at least 1 year. Cohort 1 patients (Phase 2A and 2B) must be/have: * Received no more than 1 prior line of therapy which must be platinum-based chemotherapy * Primary Platinum Resistant after completion of first line platinum-based chemotherapy Cohort 2 patients (Phase 2A and 2B) must have: * Received at least 1 prior line of treatment, 1 of which must be platinum-based chemotherapy * Received a PARP inhibitor in the maintenance setting as their most recent treatment following a confirmed response by RECIST1.1 (CR or PR) to the last regimen which must be a platinum-based chemotherapy, with maintenance of response by PARP inhibitor lasting >= 6 months, with subsequent confirmed disease progression as defined by RECIST v1.1 criteria Exclusion Criteria: * Non-epithelial tumour of the ovary, the fallopian tube or the peritoneum * Ovarian tumours of low malignant potential or low grade * Prior treatment with a topoisomerase I inhibitor * Potent inhibitors or inducers of CYP3A4 * Concurrent treatment with Coumadin (Warfarin) * History of stroke, transient ischemic attack, or myocardial infarction, within 6 months prior to C1D1 * Brain and/or leptomeningeal metastases that are symptomatic or untreated or that require current therapy. Brain imaging must not be older than 12 weeks (at the start of screening). Results with abnormal/unexpected findings of brain MRI should be discussed with the Medical Monitor as part of the screening process * Systemic anti-cancer therapy for the disease under study within 3 weeks or 5 half-lives, whichever is longer, of the first dose of study drug * Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 2 toxicities, which in the opinion of the Investigator should not exclude the patient * Patients considered by the Investigator to be at a higher baseline risk for new onset cystitis * Patients with a history, or features suggestive, of bone marrow dysplasia or myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) * Confirmed QTcF > 470 msec on screening ECG or congenital long QT syndrome * Receiving an investigational anti-cancer treatment concurrently or within 3 weeks or 5 half-lives of either the parent drug or any active metabolite, whichever is longer, prior to the first dose of study drug * Any evidence of severe or uncontrolled systemic conditions (e.g., severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol * Hypersensitivity to EP0057 or any of its excipients * Known history of Human Immunodeficiency Virus infection (HIV) (testing is not required), active infection with SARS-CoV-2, hepatitis B virus (HBV) or hepatitis C virus (HCV) per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection. All patients should be tested for an active SARS-CoV-2 infection with an approved diagnostic test kit * Malignant disease other than that being treated in this study, with the following exceptions: Malignancies that were treated curatively and have not recurred within 2 years prior to study treatment Completely resected basal cell and squamous cell skin cancers Any malignancy considered to be indolent and that has never required therapy Completely resected carcinoma in situ of any type * Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results * Any major surgical procedure (in the investigator's judgement) within 2 weeks of the first dose of study drug * Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation) * Palliative radiotherapy (e.g., for pain or bleeding) within 6 weeks prior to randomisation or patients who have not completely recovered previous radiotherapy (Grade >= 2) from the effects of previous radiotherapy * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Note: Patients with indwelling catheters (e.g.,PleurX) are allowed * Hypersensitivity or intolerance (due to safety or other reasons) to PARP inhibitors Cohort 1 patients (Phase 2A and 2B) who: * Have primary platinum refractory disease defined as progression during first line treatment with 4-6 cycles of platinum based chemotherapy Cohort 2 patients (Phase 2A and 2B) who: * Progress within 6 months during PARP inhibitor maintenance treatment * Progress after completion of PARP inhibitor maintenance treatment

Study Objectives This phase II trial studies the effect of a vaccine called CDX-1401 given with or without a biologic drug called CDX-301 in treating patients with stage IIB-IV melanoma. The cancer vaccine CDX-1401 attaches to a protein that is made in tumor cells. The vaccine helps the body recognize the tumor to fight the cancer. The biologic drug CDX-301 may help the body make more of the tumor fighting cells, known as dendritic cells. Another biologic drug, poly-ICLC, may stimulate the immune system and help these dendritic cells mature so that they can recognize the tumor. Giving CDX-301 may make the immune response to a combination of CDX-1401 and poly-ICLC better. Conditions: Cutaneous Melanoma, Melanoma, Melanoma of Unknown Primary, Mucosal Melanoma, Ocular Melanoma, Stage IIB Cutaneous Melanoma AJCC v6 and v7, Stage IIC Cutaneous Melanoma AJCC v6 and v7, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7 Intervention / Treatment: BIOLOGICAL: DEC-205/NY-ESO-1 Fusion Protein CDX-1401, DRUG: Poly ICLC, BIOLOGICAL: Recombinant Flt3 Ligand Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with fully resected stage IIb through IV melanoma, with melanoma validated by histology or cytology, who have NOT received prior therapy. * Patients may have had primary cutaneous, mucosal, or ocular melanoma or metastasis from an unknown primary site. * Tissue should be submitted for evaluation of NY-ESO-1 expression and T-cell infiltrates. However, availability of tissue and/or positivity for NY-ESO-1 is not mandatory. * Prior radiation, chemotherapy or biologics NOT allowed * Not currently receiving any anticancer therapy * Age >= 18 years * Because no dosing or adverse event (AE) data are currently available on the use of CDX-1401 or CDX-301 in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials. * Eastern Cooperative Oncology Group (ECOG) performance score of 0-1 * Life expectancy of at least 6 months * Leukocytes >= 3,000/mcL * Absolute neutrophil count >= 1,000/mcL * Platelets >= 75,000/mcL * Hemoglobin > 9 g/dL * Total bilirubin < 1.5 x institutional upper limit of normal (bilirubin < 3 x institutional upper limit of normal for Gilbert's syndrome) * Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal * Creatinine < 1.5 x institutional upper limit of normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal * The first six patients enrolled in the Flt3L arm of the study cannot be human immunodeficiency virus (HIV)-positive. After the evaluation of safety in the first 6 patients, HIV-positive patients with adequate immune function as evidenced by stable CD4 counts >= 350/mm^3 are allowed to participate if the following criteria are met: * maintained on stable antiretroviral therapy with no significant drug interactions, and * no recent history of acquired immunodeficiency syndrome (AIDS) indicator conditions (> 2 years from enrolling in trial), and * physician providing patient's care for HIV must also approve of patient entering the study * Females of childbearing potential must have a negative pregnancy test within 7 days before the initiation of protocol therapy. * The effects of CDX-1401 or CDX-301 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) before study entry and for the duration of study participation. 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 before the study, for the duration of study participation, and 4 months after completion of CDX-1401 or CDX-301 administration. * NOTE: Subjects are considered not of child-bearing potential if they are surgically sterile, they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy, or they are postmenopausal. Menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential. By a practical definition, it assumes menopause after 1 year without menses with an appropriate clinical profile at the appropriate age. * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who have had cytotoxic chemotherapy, radiotherapy, interferon (IFN), or ipilimumab before entering the study * Immunosuppressive therapy within 30 days prior to initiation of protocol therapy * Steroid therapy, or steroid therapy with more than 7 consecutive days of steroids within the prior 4 weeks * The use of prednisone or equivalent < 0.125 mg/kg/day (absolute maximum of 10 mg/day) as replacement therapy is permitted * Inhaled or topical corticosteroids are permitted * Patients who are receiving any other investigational agents * Current or history of systemic autoimmune disease requiring systemic therapy. * NOTE: The following will not be exclusionary: * The presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody [ANA] titer) without associated symptoms * Clinical evidence of vitiligo * Other forms of depigmenting illness * Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association Class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months) * Cirrhosis or chronic hepatitis C virus positivity or chronic hepatitis B infection * NOTE: A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B virus surface antibody [HBsAb]-positive and hepatitis B virus core antibody [HBcAb]-negative), or a fully resolved acute hepatitis B virus infection is not an exclusion criterion * Known history of immunodeficiency disorder other than HIV-positive status * Extensive active brain disease including symptomatic brain metastases or presence of leptomeningeal disease * NOTE: Patients with brain metastasis, after definitive therapy with surgery or stereotactic radiation and stable off steroids for >= 4 weeks, are eligible * Other invasive cancers that are clinically active * Pregnancy or nursing or unwilling to take adequate birth control during therapy * NOTE: Pregnant women are excluded from this study because CDX-1401 or CDX-301 and poly-ICLC have an unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CDX-1401 or CDX-301, breastfeeding should be discontinued if the mother is treated with CDX-1401 or CDX-301 and poly-ICLC * History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDX-1401 or CDX-301 or poly-ICLC * Prior organ allograft or allogeneic transplantation, if the transplanted tissue is still in place * 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 * Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves * History of pulmonary disease such as emphysema or chronic obstructive pulmonary disease (COPD) (forced expiratory volume in 1 second [FEV1] < 60% of predicted for height and age). Pulmonary function tests (PFTs) are required in patients with prolonged smoking history or symptoms of respiratory dysfunction * Vaccinations other than those given as part of this research study (with the exception of influenza vaccine) are prohibited throughout the duration of study participation. * NOTE: Influenza vaccination (inactivated) is permitted during the flu season. The preferred time is 7 to 14 days after CDX-1401 administration

Study Objectives An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies. Conditions: Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Non-Hodgkin's Lymphoma, Neuroblastoma Intervention / Treatment: DRUG: chemotherapy, DRUG: venetoclax Location: Germany, Canada, Netherlands, Switzerland, United Kingdom, United States, Australia, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Participants must have relapsed or refractory cancer. * Participants must have adequate hepatic and kidney function. * Participants less than or equal to 16 years of age must have performance status of Lansky greater than or equal to 50% and participants greater than 16 years of age must have performance status of Karnofsky greater than or equal to 50%. * Participants with solid tumors (with the exception of neuroblastoma) must have adequate bone marrow function in Part 1. * For the fifth cohort during Part 2 Cohort Expansion, participants with solid tumors must have evidence of BCL-2 expression (except participants with TCF3-HLF ALL). Exclusion Criteria: * Participants with primary brain tumors or disease metastatic to the brain. * Participants who have central nervous system (CNS) disease with cranial involvement that requires radiation. * Participants who have received any of the following within the listed time frame, prior to the first dose of study drug * Inotuzumab ozogamicin or gemtuzumab ozogamicin within 30 days * Biologic agent (i.e., antibodies) for anti-neoplastic intent within 30 days or 5 half-lives whichever is shorter. * CAR-T infusion or other cellular therapy within 30 days * Anticancer therapy including chemotherapy, radiation therapy, targeted small molecule agents, investigational agents within 14 days or 5 half-lives, whichever is shorter (Exceptions: Ph+ALL participants on Tyrosine Kinase Inhibitor (TKI) at Screening may enroll and remain on TKI therapy to control disease and TCF3-HLF ALL participants are allowed to have received chemotherapy within 14 days or 5 half-lives, whichever is shorter). * Steroid therapy for anti-neoplastic intent within 5 days (with the exception of TCF3-HLF ALL participants). * Requires ongoing hydroxyurea (hydroxyurea permitted up to first dose) * Participants who are less than 100 days post-transplant, or greater than or equal to 100 days post-transplant with active graft versus host disease (GVHD), or are receiving immunosuppressant therapy within 7 days prior to first dose of study drug. * Participants who are less than 6 weeks post-131 I-metaiodobenzylguanidine (mIBG) therapy. * Participants who have received the following within 7 days prior to the first dose of study drug: * Strong and moderate Cytochrome P450 3A (CYP3A) inhibitors (Part 1 Dose Determination); * Strong and moderate CYP3A inducers (Part 1 Dose Determination and Part 2 Cohort Expansion). * Participants who have not recovered from clinically significant adverse effect(s)/toxicity(s) of the previous therapy (Exception: Chemotherapy induced side effects that are expected to return to baseline in TCF3-HLF ALL participants). * Participants who have active, uncontrolled infections. * Participants with malabsorption syndrome or any other condition that precludes enteral administration. * Participants with recent positive test for SARS-CoV-2 (COVID-19) and no follow up test with negative result cannot be enrolled. Participants with contact to persons with COVID-19 and participants with signs and symptoms for COVID-19 infection must be tested before enrolling.

Study Objectives The purpose of this study is to learn how uterine fibroids may be connected to heart disease and high blood pressure. It is not known what causes fibroids, but they frequently occur in women who also have high blood pressure, heart disease, and stroke. The investigators of this study want to learn if certain changes in the blood vessels or nerve activity can put women at risk for these diseases and for fibroids. Conditions: Leiomyoma Intervention / Treatment: DEVICE: Brachial artery catheter, DRUG: Acetylcholine, DRUG: Nitroprusside, DRUG: Norepinephrine, DRUG: Nitroprusside and phenylephrine Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Women 25-50 years old * Premenopausal Exclusion Criteria: * Postmenopausal * Pregnant or currently breastfeeding * Using blood pressure medications or anti-depression medications * High blood pressure * Diabetes * Disease in the kidneys, lungs, or blood vessels * Chronic diseases (for example: Crohn's disease, rheumatoid arthritis, bipolar mood disorder, etc.) * Smoker * High cholesterol * BMI higher than 30

Study Objectives To observe the clinical efficacy and adverse reactions of capecitabine in the treatment of advanced colon cancer. A total of 150 patients with advanced colon cancer were selected by convenience sampling and then were divided into the control group (n = 50), the medium-dose group (n = 50), and the low-dose group (n = 50) using a random number table.Different administration regimens of capecitabine were given, and the treatment course was appropriately extended. The therapeutic effect and incidence of adverse reactions were observed. Conditions: Capecitabine Intervention / Treatment: DRUG: capecitabine Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * According to the diagnostic criteria for colon cancer in the Consensus on Screening, Diagnosis and Treatment of Early Colorectal Cancer and Precancerous Lesions in China , colon cancer was confirmed by pathology * TNM(tumor node metastasis) clinical stage was III or IV * Predicted survival period > 3 months Exclusion Criteria: * Patients with heart, liver, kidney and other important organ failure and contraindications to chemotherapy * Patients who received other anti-tumor therapy before admission * The disease progressed rapidly and could not be successfully completed by this researcher * Allergic to related drugs

Study Objectives Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis. Since the approval of gemcitabine as a standard treatment for advanced pancreatic patients, no drug or combination of drugs has significantly improved the prognosis. Recently, as compared with gemcitabine, FOLFIRINOX was associated with a survival advantage (11.1 vs 6.8 months), but had increased toxicity. In some retrospective studies, modified FOLFIRINOX regimen (60/120 mg/m2 of oxaliplatin and irinotecan) has an improved safety profile in digestive malignancies. The purpose of this phase II multicenter study was to investigate the efficacy and safety in patients with pancreatic cancer who progressed in gemcitabine-based first line chemotherapy. Conditions: Pancreatic Ductal Adenocarcinoma Intervention / Treatment: DRUG: modified FOLFIRINOX regimen Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Pathologically confirmed pancreatic ductal adenocarcinoma (metastatic or locally advanced stage) * Refractory or progress to Gemcitabine based 1st line chemotherapy * >= 19 years years old and younger than 75 years old * Life expectancy> 3 months * ECOG Performance status <=2 * Only patients with measurable lesions in imaging study * Adequete BM function (WBC >= 3,500/µl, absolute neutrophil cell count >= 1,500 /µl, platelet count >= 100,000/µl) * Adequete liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver involvement) * Adequete renal function (serum creatinine < 1.5 mg/dl) * Adequete cardiopulmonary function Exclusion Criteria: * Pathologically confirmed another type of pancreatic cancer (except ductal adenocarcinoma) * Metastatic adenocarcinoma of originating at other organs * Evidence with CNS metastasis * Active infection * Uncontrolled serious medical or psychiatric illness which can induce toxicity ro complication of treatment, such as inability to swallow, lacking physical integrity of the gastrointestinal tract, malabsorption syndrome, or active ulceration at upper gastrointestinal tract. * Coexisting of other malignancies within 5 years, except squamous cell carcinoma and basal cell carcinoma of the skin * Participation in any other investigational drug study within 1 month * No signed informed consent

Study Objectives This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors. Conditions: Advanced Solid Tumors Intervention / Treatment: DRUG: CS1001 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: * Subjects with metastatic or locally advanced unresectable solid tumor, who progressed following treatment with all available standard therapy, or for whom treatment is not available, not tolerated or refused. * ECOG performance status of 0 or 1. * Subjects must have at least one measurable lesion. * Patients with life expectancy >= 3 months. * Subject must have adequate organ function. * Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last study drug administration. Exclusion Criteria: * Known brain metastasis or other CNS metastasis that is either symptomatic or untreated. * Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded. * Patients who have received prior therapies targeting PD-1, PD-L1, or CTLA-4. * Known history of HIV infection. * Subjects with active Hepatitis B or C infection. * Any unresolved CTCAE Grade >= 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia. * Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma. * Known history of alcoholism or drugs abuse. * Subjects who received organ transplantation. * Known psychiatric disorders that would interfere with cooperation with the requirements of the trial. * Female subjects who are pregnant or breast-feeding; Male or female subjects of childbearing potential who refuse to use an effective method of birth control. For more information regarding trial participation, please contact at [email protected]

Study Objectives To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy. Conditions: Non-small Cell Lung Cancer Intervention / Treatment: DRUG: Erlotinib Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed non-small cell lung cancer (squamous cell, adenocarcinoma, poorly differentiated non-small cell carcinoma, or some combination of these); and * Symptomatic patients (defined at discretion of investigator) for whom palliative thoracic radiation is planned (3000cGy/10 fractions); and * At least 18 years of age. Exclusion Criteria: * Previous erlotinib therapy; or * Planned concurrent chemotherapy; or * Expected survival of less than 3 months; or * ECOG Performance Status of 3 or 4; or * Multiple CNS metastasis or a single CNS lesion that has not demonstrated radiologic stability (screening CT/MRI or head not required); or * Granulocyte count <1,500/mm3, platelet count <100,000/mm3, or haemoglobin <9.0g/dl; or * SGOT (AST) or SGPT (ALT) > 2.5 times (x) upper limit of normal (ULN) in the absence of known liver metastases or > 5 x ULN in case of known liver metastases; or * Alkaline phosphatase (ALP) > 2.5 x ULN; or * Serum bilirubin > 1.5 ULN; or * Serum creatinine > 1.5 ULN or creatinine clearance < 60 ml/min; or * Serum calcium beyond ULN; or * Patients requiring systemic anti-fungal therapy, clarithromycin, phenytoin, or oral anticoagulation therapy (see Appendix VI for complete list of medications); or * A history of interstitial lung disease; or * Known sensitivity to erlotinib; or * Pregnancy, lactation, or parturition within the previous 30 days; or * Unwillingness or inability to complete the required assessments of the trial; or * Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful informed consent; or * History of recurrent conjunctivitis or keratitis or other inflammatory changes of the surface of the eye. * Geographically inaccessible for treatment or follow-up evaluations; or * Involved in an ongoing therapeutic trial.

Study Objectives Determine the 6-month progression free survival (PFS) rate associated with cixutumumab in combination with depot octreotide acetate (octreotide) in participants with metastatic neuroendocrine tumors. Conditions: Carcinoma, Neuroendocrine Tumors Intervention / Treatment: BIOLOGICAL: Cixutumumab, DRUG: depot octreotide 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: * The participant has well-differentiated or moderately-differentiated, histologically confirmed neuroendocrine carcinoma, including carcinoid of any location and islet cell tumors * The participant has metastatic disease at the time of study entry * The participant must have a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, measurable by elevated tumor markers (eg, 24-hour urine 5-HIAA, chromogranin A, adrenocorticotropin hormone (ACTH), gastrin, or other tumor specific biochemical markers), or both * The participant is age >= 18 years * The participant's tumor has Ki-67 expression <= 20% * The participant is receiving depot octreotide therapy at the time of enrolling into the study * The participant has received 0 - 2 systemic anticancer regimens in addition to depot octreotide, which may have included chemotherapy, interferon, antiangiogenic therapy, other targeted treatments, or a combination of such treatments * The participant is no longer a candidate for surgery, embolization, or radiofrequency ablation therapy * The participant has experienced radiographic, biochemical, and/or scintigraphic disease progression while on a regimen that includes octreotide * The participant has completed prior chemotherapy and/or radiotherapy with curative intent at least 3 weeks prior to the administration of the first dose of study therapy. Participants that have received palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible * The participant has a life expectancy of > 3 months * The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2 * The participant has adequate hematologic function as defined by absolute neutrophil count >= 1500/microliters (μL), hemoglobin >= 9 gram/deciliter (g/dL), and platelet count >=100,000/μL * The participant has adequate hepatic function as defined by a total bilirubin <= 1.5 x the upper limit of normal (ULN), and aspartate transaminase (AST) and alanine transaminase (ALT) <= 3 x the ULN (or <= 5 x the ULN in the presence of known liver metastases) * The participant either has adequate coagulation function as defined by international normalized ratio (INR) <= 1.5 and partial thromboplastin time (PTT) no more than 5 seconds above the ULN, or is on a stable dose of anticoagulant * The participant has adequate renal function as defined by serum creatinine <= 1.5 x the institutional ULN or creatinine clearance >= 60 milliliter/minute (mL/min) for participants with creatinine levels above the ULN * The participant has fasting serum glucose < 160 milligram/deciliter (mg/dL) and hemoglobin A1c (HgbA1c)<= 7. If baseline nonfasting glucose is < 160 mg/dL, fasting glucose measurement is not required * Because the teratogenicity of cixutumumab is not known, women of childbearing potential (WOCBP) 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 * The participant has the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * The participant has uncontrolled brain or leptomeningeal metastases * The participant has not recovered to Grade <= 1 from adverse events due to agents administered more than 4 weeks prior to study entry (except for alopecia) * The participant is receiving any other investigational agent(s) * The participant has received therapeutic radiolabeled somatostatin analogues * The participant has received more than 2 prior regimens of systemic therapy in the metastatic setting * The participant has a history of treatment with other agents targeting the IGF receptor * The participant has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to that of cixutumumab or to octreotide * The participant has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their fasting glucose < 160 mg/dL or below the ULN and that they are on a stable dietary or therapeutic regimen for this condition * The participant has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * The participant is pregnant or lactating * The participant is known to be positive for infection with the human immunodeficiency virus * The participant has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in-situ; or c) other primary solid tumor curatively resected or treated with no known active disease present and no treatment administered for the last 3 years

Study Objectives Multicentric, phase II neoadjuvant trial in hormone-positive, HER-negative, luminal B, premenopausal breast cancer patients stage II-IIIA. Patients receive as neoadjuvant treatment before surgery: three courses of anthracycline-based chemotherapy followed by exemestane p.o. daily plus nivolumab i.v. 2-weekly for 8 courses. GnRH analogues are started concomitantly with chemotherapy and maintained until the completion of neoadjuvant treatment. Conditions: Breast Cancer Intervention / Treatment: DRUG: Epirubicin, DRUG: Cyclophosphamide, DRUG: Triptorelin, DRUG: Exemestane, DRUG: Nivolumab Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Patients may be included in the study only if they met all the following criteria * age >18 yrs * female patients * ECOG Performance Status 0-1 * must have signed and dated an IRB/IEC-approved written informed consent form in accordance with regulatory and institutional guidelines before the performance of any protocol-related procedures * Primary diagnosis of invasive breast cancer, HR positive (ER >= 10% and/or PgR >=10% by IHC) and HER2 negative (IHC 0/1+ and/or FISH/CISH negative) according to local assessment. * Histologic grade 3 and/or Ki67 >20% according to local assessment. * Stage II-IIIA * Eligible for neoadjuvant chemotherapy according to multidisciplinary evaluation. * Premenopausal status * Normal organ and marrow function * Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment * Ability to understand and willingness to sign a written informed consent document Exclusion criteria: Patients will be excluded from the study for any of the following reasons * Stage IIIB, IIIC, and inflammatory breast cancer * Stage IV breast cancer * Prior treatment with chemotherapy, biologic therapy, endocrine therapy or radiotherapy for the treatment of the newly-diagnosed breast cancer. * Contraindication to anthracycline-based chemotherapy. * Received any investigational treatment within 4 weeks of study start. * Any other concurrent chemotherapy, biologic therapy, endocrine therapy or radiotherapy for cancer treatment. * Known HIV, HBV, HCV infection or any positive tests for HBV and HCV indicating acute or chronic infection. * Known severe hypersensitivity to any of the study drugs or excipients or known severe hypersensitivity reactions to monoclonal antibodies. * Major surgical procedure or significant traumatic injury within 28 days prior to treatment initiation or anticipation of need for major surgery during the course of study treatment. * History of allogenic organ transplantation * Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident /stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class >= II), or serious uncontrolled cardiac arrhythmia requiring medication. * Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of treatment initiation. * Subjects with active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject's ability to comply with the study requirements, substantially increase risk to the subject, or impact the interpretability of study results. * Prisoners or subjects who are involuntarily incarcerated * Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness * Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medication. * Psychiatric illness/social situations that would limit compliance with study requirements * Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol * Current pregnancy and/or lactation. * Refusal to adopt adequate (highly effective) contraception methods.

Study Objectives Background Treatment and control of cancer is associated with high costs, to patients in the form of side effects and discomfort during investigations, to society in the form of expensive drugs and studies. Circulating tumor cells (CTC) has received great attention as a cancer biomarker in trying to estimate future course in patients with breast cancer, colon cancer and prostate cancer. CTC is believed to be a crucial step in cancer spreading to the bloodstream and giving rise to metastases. Detection of circulating tumor DNA (ctDNA) specifically adds specificity to the analysis of the CTC. The investigators would like to with molecular biological methods predict which patients requires special monitoring and individualized therapy and explore these tests as clinical decision support. Purpose and method In a blood sample from patients with neuro-endocrine tumor (NET) and hepatocellular carcinoma (HCC), the investigators will by cell separation, flow cytometry and DNA sequencing and digital polymerase chain reaction (PCR): 1. Identify and isolate the CTC and investigate these for tumor-specific mutations. 2. Quantify ctDNA and analyze this for specific mutations, which in the past has been found frequent in NET and HCC. 3. Compare findings of mutations on CTC and ctDNA with mutations in tissue biopsies. The results are compared with the clinical data on disease course, including the effect of treatment and survival. Subjects 40 Patients with small intestinal/unknown primary NET before treatment with somatostatin analogues 30 patients with pancreatic NET before treatment with Everolimus 30 patients with presumed radically treated HCC 30 patients with HCC in treatment with Sorafenib A blood sample will be taken prior to the start of treatment, after 1 month after start of treatment and thereafter every 3.-6. month for up to two years. Perspectives In several cancer types molecular diagnostics have had significant influence in treatment and control strategy. The goal is in future to be able to take advantage of a so-called "liquid biopsy" as clinical decision support. The study will bring new knowledge to this growing field of research. Conditions: Carcinoma, Hepatocellular, Neuroendocrine Tumors Intervention / Treatment: DRUG: Sorafenib, PROCEDURE: Radiofrequency ablation (RFA) or surgery, DRUG: Everolimus, DRUG: Lanreotide Location: Denmark Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * one of the above mentioned diseases * planed surgery, RFA, Somatostatin Analogue, Sorafenib or Everolimus treatment * signed informed consent Exclusion Criteria: * age below 18, concomitant invasive cancer (not skin cancer) and planed emigration of Denmark.

Study Objectives This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit. Conditions: Non-Hodgkin's Lymphoma, Multiple Myeloma Intervention / Treatment: DRUG: Plerixafor, DRUG: Filgrastim Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SUPPORTIVE_CARE Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with multiple myeloma or non-Hodgkin's lymphoma with a planned autologous transplant and who are eligible for peripheral stem cell mobilization. * Karnofsky Performance Status >= 70. * Age >= 18 * Less than 30% involvement of marrow with disease. Exclusion Criteria: * > 30% marrow involvement with disease * Age < 18. * Pregnant women.

Study Objectives The purpose of this study is to assess the effect of severe renal impairment on the levels of AZD9291 in the blood in patients with advanced solid tumours compared to patients with normal renal function Conditions: Solid Tumours Intervention / Treatment: DRUG: Osimertinib; AZD9291 Location: Korea, Republic of, Spain, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria: * For inclusion as a patient with severe renal impairment patient must have stable severe renal impairment (CrCl <30 mL/min at screening), for at least 2 months prior to the study. * For inclusion as a patient with normal renal function, patient must have CrCl >=90 mL/min at screening. * >18 years old * Histological or cytological confirmation of a solid, malignant tumour (excluding lymphoma) that is refractory to standard therapies or for which no standard therapies exist. Tumours in which inhibition of the EGFR pathway is considered relevant by the Investigator are not mandated but are encouraged. * ECOG performance status <=2 * Life expectancy of >=12 weeks * BMI 18-35. * Females should be using adequate contraceptive measures and must have a negative pregnancy test prior to dosing if of child-bearing potential or must have evidence of non-child bearing potential * Males should use barrier contraception until 6 months after the last study drug is taken. Exclusion criteria * Participation in another clinical study with an IP during the last 14 days (or a longer period, depending on the agents used). * Treatment with any of the following: * Treatment with a 1st or 2nd generation EGFR-TKI within 8 days or approximately 5 half-lives, prior to the first dose of study drug. * Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 14 days of the first dose of study drug. * Osimertinib in the present study or has previously received a 3rd generation EGFR-TKI (eg, CO 1686). * Major surgery within 4 weeks of the first dose of study drug. * Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment * Currently receiving medications or herbal supplements known to be potent inducers of CYP3A4. Patients in Part B and continued access must avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known potent inducer effects on CYP3A4. * Patients with severe renal impairment only: use of concurrent medication known to affect CrCl within 7 days of the first dose * Unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment; with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy * Spinal cord compression or brain metastases, unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment * Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: * Absolute neutrophil count <1.5 x 109/L * Platelet count <100 x 109/L * Haemoglobin <90 g/L * ALT >2.5 times the ULN if no demonstrable liver metastases or >5xULN in the presence of liver metastases * AST >2.5xULN if no demonstrable liver metastases or > 5xULN in the presence of liver metastases * Total bilirubin >1.5 times ULN if no liver metastases or >3xULN in the presence of liver metastases * Any of the following cardiac criteria: * Mean resting QT interval QTcF >470 msec, obtained from 3 ECGs. * Abnormalities in rhythm, conduction or morphology of resting ECG * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval * Unable to swallow oral medication or patients with GI disorders or significant GI resection. * Medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD. * Severe portal hypertension or surgical porto-systemic shunts. * Kidney transplant * On dialysis

Study Objectives This study will assess the ability of Doxorubicin, Vincristine and Dexamethasone plus arsenic trioxide to achieve an overall response rate of greater than 60%. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Doxil®, DRUG: Vincristine, DRUG: Dexamethasone, DRUG: Arsenic Trioxide 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: * Must have Multiple Myeloma * No prior chemotherapy, thalidomide, or corticosteroids treatments for Multiple Myeloma * ECOG performance status must be 0-2 Exclusion Criteria: * Resting left ventricular cardiac ejection fraction >=50% by echo or MUGA scan. * QT interval >=480 msec on baseline ECG. * No history of cardiac disease. * Pregnant or breast-feeding. * No history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil. * History of prior or concurrent malignancy or myelodysplasia.

Study Objectives Sequential therapy with BEvacizumab, RAd001 (everolimus) and Tyrosinekinase inhibitors (TKI) in metastatic renal cell carcinoma (mRCC) Conditions: Metastatic Renal Cell Carcinoma Intervention / Treatment: DRUG: Avastin in combination with Roferon-A, DRUG: Afinitor, DRUG: TKI: Sutent, Nexavar or Votrient Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Signed Informed Consent * Documented progressive disease prior to study inclusion. * Adult males and females: >= 18 years of age. * Metastatic or locally advanced RCC, not amendable to surgery with curative intention. * ECOG performance status 0-1. * Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) If prior palliative radiotherapy to metastatic lesions: >= 1 measurable lesion that has not been irradiated. Patients with bone lesions as the only measurable lesion are eligible, provided that lesions consist of soft tissue, which is assessed via CT or MRI. * Prior radiotherapy and surgery are allowed if completed 4 weeks (for minor surgery 2 weeks) prior to start of treatment and patient recovered from toxic effects. * Modified MSKCC risk (according to Heng): good or intermediate. * White blood cell count (WBC) >= 4x10*9/L with neutrophils >= 1.5 x 10*9/L, platelet count >= 100x10*9/L, hemoglobin >= 9 g/dL. * Total bilirubin <= 2 x upper limit of normal. * AST and ALT <= 2.5 x upper limit of normal, or <= 5 x upper limit of normal in case of liver metastases. * Serum creatinine <= 2 x upper limit of normal or calculated creatinine clearance >30 ml/min. * International Normalized Ratio (INR) <=1.5 except for patients on stable anticoagulant therapy. Activated partial thromboplastin time (aPTT) <=1.5 times upper limit of normal (ULN) or greater than the lower limit of the therapeutic range. Note: The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks at the treatment start. * Adequate cardiac function (left ventricular ejection fraction >=50% as assessed by ECHO) Exclusion Criteria: * Any investigational drug within the 30 days before inclusion. * Known or suspected allergy or hypersensitivity reaction to any of the components of study treatments or their excipients. * Pregnancy (absence to be confirmed by beta-hCG test) or lactation period. * Men or women of child-bearing potential who are sexually active and unwilling to use a highly effective method of contraception (Pearl index < 1%) during the trial. Oral contraceptives are acceptable if a barrier method is applied in conjunction. * Clinically symptomatic brain or meningeal metastasis (known or suspected), unless completion of local therapy for at least 3 months with discontinuation of steroids prior to start of treatment. * Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers, digoxin or digitoxin). * History of any of the following cardiac events within the past 6 months: 1. myocardial infarction (including severe/unstable angina), 2. coronary/peripheral artery bypass graft, 3. congestive heart failure (CHF) (NYHA Class III, or IV), 4. cerebrovascular accident, 5. transient ischemic attack, 6. pulmonary embolism, abdominal or tracheo-oesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess * Hemorrhage >= grade 3 or clinically significant hemoptysis within the past 4 weeks * Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of >= 3 anti-hypertensive drugs). * History of relevant pulmonary hypertension or interstitial lung disease or severely impaired lung function. * Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea. * Previous malignancy (other than renal cell cancer) in the last 3 years, except basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a prostate carcinoma or superficial bladder tumor [Ta, Tis and T1]. * History of organ allograft. * Significant disease which, in the investigator's opinion would exclude the patient from the study. * Medication that is known to interfere with any of the agents applied in the trial. * Patients with a serious non-healing wound, ulcer or bone fracture. * Patients with a history of seizure(s) not controlled with standard medical therapy. * Patients receiving chronic systemic treatment with corticosteroids (dose of > 20 mg/day methylprednisone equivalent) or another immune-suppressive agent. Inhaled and topical steroids are acceptable. * Legal incapacity or limited legal capacity. * Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent. * Significant vascular disease (e.g. aortic aneurysm, aortic dissection), or symptomatic peripheral vascular disease. * Evidence or history of recurrent thromboembolism (>1 episode of deep venous thrombosis/peripheral embolism >= CTCAE Grade 3) during the past 2 years, bleeding diathesis or coagulopathy. * Poorly controlled diabetes as defined by fasting serum glucose > 2.0 x ULN. * Active (acute or chronic) or uncontrolled infection of bacterial, mycotic or viral genesis. * Liver disease such as chronic active hepatitis or chronic persistent hepatitis. * Patients with a known history of HIV seropositivity. * QT prolongation (QTc > 450 msec).

Study Objectives This study evaluates the benefit in women aged from 30 to 65 years, who do not participate to the French opportunistic cervical cancer screening program, of an organized screening with the proposition by the family physician of a pap-test (usual care) versus a self-collected vaginal sample (and a HPV-test). 24 family physicians will participate and will be randomized in the usual care arm (12) or in the self-sampling arm (12). Our hypothesis is that organizing the screening for these women involving their family physician will major participation, and that the self-sampling option will amplify this increase. Conditions: Malignant Tumor of Cervix, Cervical Intraepithelial Neoplasia Intervention / Treatment: DEVICE: Vaginal self-sampling brush Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * To be a woman * Aged from 30 to 65 years (30 and 65 years included) * Without reimbursement of a pap-test by the health insurance for more than 3 years, despite a reminder mailed by the health insurance on the previous year (list set up by the health insurance). * Able to understand and sign voluntarily the consent to participate * Warranted by the health insurance * Able to understand and answer the questions of the study questionnaire alone or with the help of a self-chosen third party. Exclusion Criteria: * No vaginal intercourse ever * Pap-test quoted on another budget (hospital, mother and child protection...) conducted less than 3 years ago * Known cervical lesion or known HPV status * History of hysterectomy * History of conisation * History of laser treatment of the cervix * History of cervical cancer * Other medical reason to delay cervical cancer screening * Abroad for more than one year * Moving to another region (done or expected) * Pregnant or breastfeeding * Screening not relevant from the practitioner's perspective (Emergency situation, comorbidity...)

Study Objectives A Phase 2, randomized, double-blind, dose rising study to determine the safety, tolerability, and preliminary efficacy of four concentrations of SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment (SOR007) compared to SOR007 ointment vehicle applied to actinic keratosis (AK) lesions on the face twice daily for up to 28 days. Conditions: Actinic Keratosis Intervention / Treatment: DRUG: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment, OTHER: SOR007 Ointment Vehicle Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SEQUENTIAL Masking: TRIPLE

Inclusion Criteria: * Signed informed consent. * Men and women with actinic keratosis. * Age 45-85. * Women who have had surgical sterilization or are post-menopausal (absence of menses for at least one year) are eligible. Women of child-bearing potential who are non-pregnant, non-nursing, and willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study are eligible. (Adequate contraception is defined as regular use of diaphragm with condoms, IUD with condoms, or systemic contraceptives if used for at least three months prior to enrollment in the study.) A negative pregnancy test is required as an entry criteria. Women must continue to use the method of contraceptive for at least 30 days after the last administration of study drug. * Male subjects must agree to sexual abstinence or use adequate contraception when sexually active in combination with their female partners, if they are of childbearing potential. That means the volunteer must be vasectomized or use a condom and his female partner must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, or non-DalKon Shield IUDs. This applies from signing of informed consent form until 90 days after the last study drug administration. Methods of contraception must have been effective for at least 30 days on the day of signing of informed consent. Male volunteers must also refrain from sperm donation from the time of singing informed consent form until 90 days after the last study drug administration. * Presence of 4-8 AK lesions total in a 25 cm2 area identified on the face through transparency mapping and photographs. The face area will be defined from hair line to jaw line. The scalp will not be included. An imaginary normal hair line will be the upper boundary for bald men. * Able to refrain from the use of all other topical medications to the facial area during the treatment period. * Considered reliable and capable of understanding their responsibility and role in the study. Exclusion Criteria: * History of allergy or hypersensitivity to paclitaxel. * Lesions that are thicker than 1 mm or larger than 9 mm will not be included in the lesion counts. * Lesions suspicious for squamous cell carcinoma, basal cell carcinoma, or melanoma will not be included in lesion counts and cannot be in the 25 cm2 area of treatment. * Abnormal pre-existing dermatologic conditions which might affect the normal course of the disease (e.g. albinism or chronic vesiculobullous disorders). * Positive urine pregnancy test in women of child-bearing potential. * Inability to use adequate birth control measures for men or women of child-bearing potential, as defined above. * Serious psychological illness. * Significant history within the past year of alcohol or drug abuse. * During the 30 day period preceding study entry: Participating in any clinical research; using topical paclitaxel for AK; using any other topical agents including but not limited to actinex, glycolic acid products, alpha-hydroxy acid products, and chemical peeling agents for the treatment of AK; using any systemic steroids or topical corticosteroids, having cryosurgery. * Use of sun lamps or sun tanning beds or booths during the 2 weeks prior to first application and until final visit. * Prior treatment with systemic paclitaxel or systemic cancer therapy within 6 months of study entry. * Medical history which, based on the clinical judgment of the Investigator implied an unlikelihood of successful completion of the study.

Study Objectives The purpose of this study is to assess the patient self-medication practices during and after cancer in France, using an online questionnaire Conditions: Cancer, Self-medication Location: France Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Past or active cancer Exclusion Criteria: * Speaking French * Not living in France

Study Objectives The purpose of this trial is to evaluate the safety and efficacy of long-term treatment with NPC-12G gel (0.2% sirolimus gel) to angiofibroma and other skin lesions in patients with tuberous sclerosis complex in the open-label trial. Conditions: Tuberous Sclerosis, Angiofibroma, Hypomelanotic Macule, Plaque Intervention / Treatment: DRUG: NPC-12G gel Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female patients 3 years old or greater at the time of informed consent * Patients who are diagnosed as definite diagnosis according to diagnostic criteria for tuberous sclerosis complex (International Tuberous Sclerosis Complex Consensus Conference 2012) * Patients with skin lesions such as angiofibroma, white macules or plaque upper neck associated with tuberous sclerosis complex at the screening visit or the baseline visit * Patients or his/her guardian who agree to use the test drug (NPC-12G gel) or who want to participate in the trial again following participation in Phase III trial (NPC-12G-1) * Patient who are considered to be an appropriate patient to participate in the trial by investigator * Patients or his/her guardian who give a written informed consent in understanding and willingness after having received enough explanation of the test drug and the current trial plan Exclusion Criteria: * Patients who have offered to withdraw from Phase III trial (NPC-12G-1) and have been discontinued * Patients who have not applied the test drug topically more than 25% of whole applications without appropriate reason for Phase III trial (NPC-12G-1) * Patients with clinical findings such as erosion, ulcer and eruption on or around the lesion of angiofibroma, which may affect assessment of safety or efficacy * Patients with a history of hypersensitivity to alcohol or allergy to sirolimus * Patients who have complications such as malignant tumor, infection, serious heart disease, hepatic function disorder, renal function disorder or blood disorders which severity are considered by investigator as grade 2 or more severe with reference to ''Concerning classification criteria for seriousness of adverse drug reactions of medical agents'' * Patients who have complications such as diseases unsuitable for the trial participation, for examples, uncontrolled diabetes (fasting blood glucose level >140 mg/dL or postprandial blood glucose level > 200 mg/dL), dyslipidemia (cholesterol level > 300 mg/dL or > 7.75 mmol/L, triglycerides level > 300 mg/dL or > 3.42 mmol/L), etc. * Female patients who may be pregnancy or are lactating * Patients who cannot agree to take appropriate measures of contraception until completion of the trial or follow-up period after discontinuation from informed consent * Patients who have participated in other clinical trial other than Phase III trial (NPC-12G-1) and have taken a trial drug within 6 months before informed consent * Others, patients who are considered by the investigator as unsuitable for participation in the trial

Study Objectives The study hypotheasis is that curcumin, a natural compound with a potent antiproliferative effect, can improve the efficacy of the standard chemotherapy gemcitabine in patients with advanced pancreatic cancer. That is why the patients are given a daily oral dose of 8 gr of curcumin along the chemotherapeutic protocol of weekly gemcitabine. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: curcumin (+ gemcitabine) Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * locally advanced or metastatic adenocarcinoma of the pancreas * no prior chemotherapy * performance status 0-2 * adequate hematology and chemistry Exclusion Criteria: * serious concurrent medical condition

Study Objectives Pain after surgery for lung cancer (thoracotomy) may persist for years and require long-term analgesic use. Prior studies have shown that acupuncture reduces pain and medication use in the early post-operative period after abdominal surgery, suggesting that acupuncture may have a role in preventing chronic post-thoracotomy pain. This study is being done in order to determine the effects of acupuncture on pain in patients undergoing surgery for lung cancer. Conditions: Lung Cancer, Pain Intervention / Treatment: PROCEDURE: Acupuncture and Questionnaires, PROCEDURE: Placebo Acupuncture, Questionnaires Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Patients undergoing unilateral thoracotomy at Memorial Sloan-Kettering Cancer Center (MSKCC) * Age greater than or equal to 18 years old. Exclusion Criteria: * Any of the following procedures: hemiclamshell, clamshell, extrapleural approach, chest wall involvement, esophagectomy. These more extensive procedures have a higher risk of complications. * Acupuncture treatment in the previous six weeks, to discount any persisting effect of acupuncture * Platelets < 20,000 or International Normalized Ratio (INR) > 2.5 or absolute neutrophil count (ANC) < 0.5; though it would be unusual for any patient to be operated on with such values, it seems wise as a precautionary measure to avoid risk of bleeding from acupuncture. * Known cardiac conditions constituting a high or moderate risk of endocarditis as defined by the American Heart Association criteria * Patients unable to remove studs without assistance, who have no home assistance, and who are unable or unwilling to return to the hospital in the event that they decide to remove studs before the post-discharge visit.

Study Objectives A pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: letrozole Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast * on hormone replacement therapy * postmenopausal * increased risk of developing breast cancer based on personal or family history * never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months * women who have a high risk of breast cancer * older than 18 years Exclusion Criteria: * anticoagulants * marked breast tenderness * pregnant or within twelve months of breast feeding/childbirth

Study Objectives The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. The uptake of the novel radiopharmaceutical 18F-FPPRGD2 will be assessed in study participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC) who are receiving antiangiogenesis treatment. Conditions: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Male Breast Cancer, Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Adult Brain Tumor, Recurrent Basal Cell Carcinoma of the Lip, Recurrent Colon Cancer, Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Recurrent Hypopharyngeal Cancer, Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Recurrent Laryngeal Cancer, Recurrent Lip and Oral Cavity Cancer, Recurrent Lymphoepithelioma of the Nasopharynx, Recurrent Lymphoepithelioma of the Oropharynx, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Nasopharyngeal Cancer, Recurrent Non-small Cell Lung Cancer, Recurrent Oropharyngeal Cancer, Recurrent Pancreatic Cancer, Recurrent Paranasal Sinus and Nasal Cavity Cancer, Recurrent Rectal Cancer, Recurrent Renal Cell Cancer, Recurrent Salivary Gland Cancer, Stage IIIA Breast Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Breast Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer, Stage IV Non-small Cell Lung Cancer, Stage IV Pancreatic Cancer, Stage IV Renal Cell Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVA Salivary Gland Cancer, Stage IVB Colon Cancer, Stage IVB Salivary Gland Cancer, Stage IVC Salivary Gland Cancer, Tongue Cancer, Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: 18F-fludeoxyglucose (18F-FDG), DRUG: 18F-FPPRGD2 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Provides written informed consent * Diagnosed with advanced NSCLC, breast cancer, GBM or other cancers (such as head and neck, colorectal, pancreatic, renal cancers); patients will undergo anti-angiogenesis treatment or treatment with other drugs that may alter angiogenesis * Able to remain still for duration of each imaging procedure (about one hour) Exclusion Criteria: * Pregnant or nursing * Contraindication to MRI * History of renal insufficiency (only for MRI contrast administration)

Study Objectives This phase I trial studies the side effects and best dose of fluorouracil when given together with radiation therapy followed by combination chemotherapy before and after surgery in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving additional combination chemotherapy after surgery may kill any remaining tumor cells. Giving radiation therapy and fluorouracil followed by combination chemotherapy before and after surgery may be a better treatment for rectal cancer. Conditions: Mucinous Adenocarcinoma of the Rectum, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Rectum, Rectal Adenocarcinoma, Stage IIA Rectal Cancer, Stage IIB Rectal Cancer, Stage IIC Rectal Cancer, Stage IIIA Rectal Cancer, Stage IIIB Rectal Cancer, Stage IIIC Rectal Cancer Intervention / Treatment: RADIATION: intensity-modulated radiation therapy, DRUG: fluorouracil, DRUG: oxaliplatin, DRUG: leucovorin calcium, PROCEDURE: therapeutic conventional surgery 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: * Pathologically proven diagnosis of adenocarcinoma of the rectum (located below the peritoneal reflection or begins within 15 cm of the anal verge on flexible endoscopy) within 90 days of registration; diagnosis of rectal adenocarcinoma must be obtained by biopsy technique that does not completely excise the lesion (eg, fine needle aspiration, core needle biopsy) * Clinically determined to be clinically staged (American Joint Committee on Cancer (AJCC) 7th edition [ed.]) T3-4 N0 M0 or T any N1-2 M0 based upon the following minimum diagnostic workup within 90 days prior to registration: * Colonoscopy * History/physical examination (including medication history screen for contraindications) * Contrast-enhanced imaging of the abdomen and pelvis either by computed tomography (CT), magnetic resonance imaging (MRI), or whole body positron emission tomography (PET)-CT (preferred) * Chest x-ray (or CT) of the chest to exclude distant metastases (except for those who have had whole body PET-CT per above bullet point) * Transrectal ultrasound (TRUS) or MRI for T staging * Eastern Cooperative Oncology Group (ECOG) performance status =< 1 * Absolute neutrophil count (ANC) >= 1,800 cells/mm^3 * Platelets >= 100,000 cells/mm^3 * Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable) * Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN) * Alkaline phosphatase < 2.5 x ULN * Bilirubin =< 1.5 ULN * Calculated creatinine clearance (CrCl) > 50 mL/min using Cockcroft-Gault formula * Must be deemed a candidate for curative resection by the surgical oncologist who will be performing the operation * Must provide study-specific informed consent prior to study entry * Must have a negative serum pregnancy test Exclusion Criteria: * Prior radiotherapy to the region of the body that would result in overlap of RT fields with the current protocol treatment * Severe, active comorbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol * Evidence of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of treatment protocol or follow up * Known, existing uncontrolled coagulopathy; subjects on therapeutic anticoagulation may be enrolled provided that they have been clinically stable on anti-coagulation for at least 2 weeks * Major surgery within 28 days of study enrollment (other than diverting colostomy) * Crohn's disease or ulcerative colitis requiring hospitalization, surgery or immunosuppressive medications * Prior allergic reaction to 5-Fluorouracil or oxaliplatin * Any evidence of distant metastases (M1) * Extension of malignant disease into the anal canal * Pregnant as determined by a positive serum pregnancy test within 14 days prior to registration on study (for females of childbearing potential)

Study Objectives This is a single-arm, multi-center Phase II trial using IL-15 super-agonist complex (N-803 formerly known as Alt-803) maintenance after allogeneic hematopoietic cell transplant (alloHCT) for acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). Conditions: Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS) Intervention / Treatment: DRUG: N-803 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: * Diagnosis of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for whom an allogeneic hematopoietic stem cell transplant using a reduced intensity conditioning is planned or has been performed and patient is prior to day 60 post-transplant. * Able to begin study treatment between day +42 and day +60 after the transplant and meets the following transplant related requirements: * Sustained neutrophil (ANC > 1000/mcL) and platelet (> 30,000/mcL) engraftment * >50% donor myeloid and lymphoid chimerism blood or bone marrow on most recent bone marrow (BM) evaluation * No evidence of recurrent disease on most recent bone marrow evaluation (day 21 or 28 post-transplant is acceptable) * No morphologic evidence of relapse (< 5% bone marrow blasts) on most recent BM evaluation (Day 21 or 28 post-transplant is acceptable) * Being followed in the outpatient setting (not an inpatient) * No plan of giving other anti-cancer treatment directed at diseases under study (i.e. maintenance therapy [e.g. sorafenib for FLT3m+ AML or hypomethylating therapy], additional therapy for MRD) * If acute GVHD is present it must be clinically improving on topical steroids and/or on low dose systemic steroids (<= 0.3 mg/kg/day prednisone) and with clinical stability for at least 1 week prior to determination of eligibility. GVHD prophylaxis will be continued per individual institutional standard practice * One of the following donor graft sources used for the transplant: * Group 1: sibling donor * Group 2: haploidentical donor [with post-transplant cyclophosphamide] * Group 3: unrelated donor * Group 4: unrelated umbilical cord blood * Karnofsky performance status >= 70% * Adequate organ function within 14 days of study enrollment defined as: * Renal: serum creatinine: <= 2.0 mg/dL * Hepatic: SGOT <= 3 x upper limit of institutional normal (ULN) * Sexually active females of child-bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy. * Voluntary written consent prior to the performance of any research related procedures Exclusion Criteria: * Prior N-803 (previously known as ALT-803) * Pregnant or breastfeeding - N-803 is an investigational agent. Women of child bearing potential must have a negative pregnancy test at screening. * Class II or greater New York Heart Association Functional Classification criteria or serious cardiac arrhythmias likely to increase the risk of cardiac complications of cytokine therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or supraventricular tachyarrhythmia requiring chronic therapy) * Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval > 500 milliseconds) * Active uncontrolled bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and must be afebrile for at least 24 hours at time of enrollment. * Active autoimmune disease requiring immunosuppressive therapy (GVHD prophylaxis is permitted per institutional practice) * History of severe asthma and currently on chronic medications (mild asthma requiring inhaled steroids only is eligible) * Received any investigational agent within the 14 days before the start of study treatment (1st dose of N-803)

Study Objectives The purpose of this research study is to collect specimen samples and study medical information from women with Polycystic Ovary Syndrome (PCOS) and women without PCOS. The goal is to learn more about the changes that take place in the body that result in PCOS. We anticipate that 32 women will take part in this study (16 without PCOS and 16 with PCOS). All patients will undergo a physical exam, blood tests, and ultrasound of their ovaries. If they meet the criteria for this study, they will then undergo additional blood tests, removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat (i.e., DXA scan) and a modified frequently-sampled intravenous glucose tolerance test (FSIGTT). The women without PCOS will complete the study at this point. The women with PCOS will be randomized to receive the drug flutamide 125 mg/day or placebo. They will take the drug every day for six 28-day cycles. They will be asked to collect and store a urine sample once a week. They will also be asked to complete a pill diary and menstrual diary. Once a month while they are taking the flutamide/placebo, they will return to the clinic and bring their frozen urine samples. At that time they will undergo a physical exam, toxicity assessment, and blood draw. Quality of Life assessments will be done at the beginning of the study for all participants. Women with PCOS who are taking the flutamide or placebo will be asked to repeat the Quality of Life assessments during the study and at the end of the study. After the six 28-day cycles are completed they will then undergo additional blood tests, removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat (i.e., DXA scan) and a modified frequently-sampled intravenous glucose tolerance test (FSIGTT). Six months following the completion of all study protocol procedures, participants who received flutamide/placebo will be contacted by phone to check on the status of their health. They will be asked if they have experienced any health problems or have become pregnant since they completed the study procedures. Conditions: Polycystic Ovary Syndrome (PCOS) Intervention / Treatment: DRUG: Flutamide, OTHER: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Women between the ages of 18 to 35 years. Groups will be: 16 lean controls and 16 age- and BMI-matched PCOS women randomized to flutamide vs. placebo for 6 months. i) Lean patients with PCOS: 16 subjects with PCOS (defined by 1990 NIH criteria [all Aims]), BMI 18.5-25 kg/m2. This BMI range is defined as normal and has been chosen to examine underlying mechanisms of PCOS-related androgen excess in the genesis of adipogenic and ovarian dysfunction, independent of obesity. ii) Lean control women: 16 healthy subjects, BMI 18.5-25 kg/m2. Controls will have regular menstrual cycles, and no evidence of hirsutism, acne, alopecia, polycystic ovaries, and/or endocrine dysfunction. This BMI range has been chosen to match that of the PCOS group. Exclusion Criteria: * Exclusion criteria for study participation are: present or past history (<1 years) of smoking, cancer, alcohol abuse, drug addiction, severe depression, or post traumatic stress; diabetes; uncontrolled hypertension (>= 165/100); clinically significant hepatic or renal disease, or other major medical illness; recent (within 3 months) use of androgens, anabolic steroids or hormonal agents (including birth control pills or insulin sensitizers). These exclusion criteria are chosen to avoid effects from medical conditions, environmental factors or exogenous agents. Women taking the drug warfarin, CYP active medications, or herbs will be excluded. The screener will assess the participants response to establish if depression or drug use exclude participation in this study. Women taking beta blockers will be excluded. Women who have taken birth control pills or had a Mirena IUD or used Plan B contraception during the previous 3 months will be excluded.

Study Objectives This open label extension study will give an opportunity to the participants that have responded to the treatment with Pegylated-Interferon Alfa-2a (Pegasys) or Recombinant Interferon Alfa-2a (Roferon-A®) in prior clinical studies NO15753 (NCT00003542) for Renal Cell Carcinoma (RCC), NO15764 (NCT number not available) and NO16006 (NCT02736721) for Chronic Myelogenous Leukemia (CML), and NO16007 (NCT number not available) for Malignant Melanoma (MM). Conditions: Chronic Myelogenous Leukemia, Malignant Melanoma, Renal Cell Carcinoma Intervention / Treatment: DRUG: Pegylated Interferon Alfa-2a, DRUG: Recombinant Interferon Alfa 2a Location: Bulgaria, India, Canada, Spain, Slovakia, South Africa, Russian Federation Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Participants must have completed protocol NO15753, NO15764, NO16006 or NO16007 and responded to treatment at the end of the trial as defined in the parent protocol * CML participants must have a confirmed cytogenetic complete response within 2 months of entering the extension study. MM and RCC participants must have tumour assessments verifying stable or better response within 2 months of entering the extension study Exclusion Criteria: * Pregnant or lactating women * Refusal to use adequate contraceptive measures among men and women of childbearing potential

Study Objectives This is a Phase I dose escalation study to determine how much chemotherapy can be safely administered into the abdomen while experiencing the fewest possible side effects. Conditions: Colorectal Cancer, Appendix Cancer, Peritoneal Carcinomatosis Intervention / Treatment: DRUG: Oxaliplatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Must be 18 years of age or older and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with institutional policy * Must consent to participate in the trial and have signed an approved informed consent form conforming to institutional policy * Must have histopathologically or cytologically confirmed colon, rectal or appendiceal adenocarcinoma with synchronous or metachronous peritoneal dissemination of disease.(Stage IV peritoneal based disease only) * Must have active measurable disease by either abdominal computerized axial tomography (CT)/ Magnetic resonance imaging (MRI) or laparoscopy. Adequate laboratory values * Absolute neutrophil count (ANC) > 1200/10*3/uL * Platelet count > 140,000/10*3/uL * Total serum bilirubin <= 1.5 mg/dl (patients with total bilirubin >1.5 mg/dL are eligible only with Gilbert's syndrome) * Alkaline phosphatase < 2.5 times the upper limit of normal (ULN) (alkaline phosphatase and AST cannot both exceed the ULN) * Aspartate aminotransferase (AST) < 1.5 times the ULN (alkaline phosphatase and AST cannot both exceed the ULN) * Serum renal function parameters (BUN and creatinine) are within normal limits (eGFR) >50) * Satisfactory cardiopulmonary function (as determined by Physician) * Patients can have received prior systemic chemotherapy, radiation or surgery * Patients must be able to undergo placement of an intraperitoneal (IP) catheter and a Port-A Cath, if not already present * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less * Women of reproductive age and men who are sexually active must be willing to practice effective contraception * Patients will be allowed to have secondary malignancies as long as they do not require active concomitant treatment

Study Objectives This is a phase I, prospective, open-label, single center, dose finding study with Atu027 (an siRNA formulation) given as single treatment followed by repeated treatment (repeated treatment phase: 8 treatments within 4 weeks) as therapy in subjects with advanced solid cancer. Conditions: Advanced Solid Tumors Intervention / Treatment: DRUG: Atu027 Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically and/or cytologically proven advanced, recurrent or metastatic solid malignancy for which standard curative or palliative measures do not exist, are no longer effective, or are unlikely to be effective. * Age >= 18 years. * ECOG performance score of 0-2. * Life expectancy of at least 3 months. * Subjects must have recovered from the acute reversible effects of previous anti-cancer therapies. At least 30 days since major surgery and at least 5 half-lives (t1/2) must have elapsed since treatment with any investigational agent. * Adequate marrow, hepatic, renal, and heart function at the time of screening. * Weight >= 50kg. * Subjects must have at least one measurable lesion according to RECIST. * Women of childbearing potential must have a negative urine pregnancy test at baseline. * Women of childbearing potential and men must be willing to use highly effective contraceptive methods during the course of the study and three months after. * Subjects must be willing and able (in the opinion of the investigator) to understand the subject information and informed consent form and to comply with the study protocol and procedures. * Subjects must be willing and able to give written informed consent. Exclusion Criteria: * Evidence of central nervous system (CNS) metastases. * Peripheral venous access insufficient to permit intravenous infusion or acquisition of laboratory specimen. * Major surgery within 30 days prior to first study treatment. * Evidence that subject has only insufficiently recovered from the acute reversible effects of previous anti-cancer therapies or surgery. * Abnormal hematologic parameters as defined: * Neutrophil count < 1.500/mm3 (=1.5x10^9/l) * Platelet count < 100.00/mm3 (=100x10^9/l) * White blood cells < 3x10^9/l * Hemoglobin < 9.0 g/l * Abnormal renal or hepatic function as defined: * ASAT (SGOT), ALAT (SGPT) >= 1.5xULN or >= 2.0xULN in case of liver metastases * Total bilirubin >= 1.5xULN * Creatinine clearance < 50ml/min calculated by the Cockroft-Gault formula * Weight < 50 kg. * Any concurrent disease, medical or social condition that could affect compliance with the protocol or interpretation of results as judged by the investigator. In particular, subjects with the following conditions are not allowed to enter the study: * Seizures * Poorly controlled Diabetes mellitus * Lipid metabolism disorder (cholesterol and triglycerides >= 1.5xULN), Refsum disease * Myocardial infarction within six (6) months prior to enrollment or having insufficient cardiac function defined as NYHA Grade 3 or 4, uncontrolled angina, cardiomyopathy, severe uncontrolled ventricular arrhythmias, left bundle branch block or electrocardiographic evidence of acute ischemic or active conduction system abnormalities (e.g. long QT interval, Torsade de Pointes) * Poorly controlled hypertension * Severe dyspnea or severe pulmonary dysfunction * Autoimmune and inflammatory disease * Active infection or known bacteremia * Known infection with HIV or chronic infection with hepatitis B or C virus * History of acute or chronic pancreatitis * Substance abuse * Prior gene transfer therapy. * Concurrent treatment with investigational or commercial agents or therapies administered with the intention to treat the subject's malignancy. * Participation in any other clinical study or use of investigational device(s) during participation in this study. * Known hypersensitivity to ingredients of the infusion solution. * Pregnant or nursing women or women of childbearing potential who are not willing to use highly effective forms of contraception during participation in this study and at least three months thereafter. * Male subjects with partners of child-bearing potential who are not willing to use highly effective contraception during participation in this study and for at least three months thereafter, unless surgically sterile. * Subject is a relative of, or staff directly reporting to the investigator or employee of the sponsor.

Study Objectives This is a multi-centre Phase III randomized controlled study of patients with multiple myeloma (MM). Eligible patients who are not candidates for transplantation will be randomized to receive eight courses of Melphalan/Prednisolone with or without Thalidomide treatment. Thalidomide will be initiated at the dose of 100 mg/day and maintained at 100 mg/day. The patients will be assessed for any responses at the end of 2nd, 4th, 6th and 8th cycles of treatment. The toxicities will be assessed at monthly intervals. Patients will be assessed for the: 1. Incidence and grade of any toxicity 2. Level of maximum disease response 3. Time to disease progression 4. Time to death Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Thalidomide, DRUG: Melphalan+Prednisolone Location: Turkey Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age above 55 years old. * Diagnosis of MM (Appendix A) and staging (Appendix B), previously untreated. * Performance status ECOG, 0, 1, or 2 (Appendix C). * Written informed consent to the study medications and bone marrow biopsy at diagnosis, 12 weeks and 6 months and/or off-study assessment. * Women who are pregnant or lactating at the time of diagnosis are ineligible. All women of child-bearing potential must have a negative pregnancy test within 24hrs of commencing the thalidomide and must take adequate precautions to prevent pregnancy and should not plan on conceiving children during the treatment program: * Adequate precautions are defined as "at least one highly effective method i.e., IUD, hormonal (birth control pills, injections, or implants), tubal ligation, partner's vasectomy AND one additional effective method i.e., latex condom, diaphragm, cervical cap". * Women becoming pregnant on protocol will be removed immediately from protocol. * Male patients (including patients having had a vasectomy) must use barrier contraception during and for four weeks after completing the thalidomide. * Patients remain eligible in the presence of abnormal renal function and/or liver function at time of enrollment. * Absence of severe dementia, able to take medication at home. * Absence of systemic disorders (gastrointestinal, pulmonary, cardiac and neurological). Exclusion Criteria: * Asymptomatic myeloma or solitary plasmacytoma of bone or extramedullary plasmacytoma (without evidence of myeloma). * Previous or concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas. * Previous treatment for myeloma, except minimal local radiotherapy to relieve bone pain. * Other illnesses which would preclude chemotherapy administration or patient compliance. * Any other serious medical or psychiatric illness which would prevent informed consent. * Peripheral neuropathy > NCI criteria grade 2. * Pregnant or lactating women and patients of childbearing age who refuse to use contraception. * History of hypersensitivity to thalidomide or any component of the medications.

Study Objectives Purpose of the study: The purpose of this study is to make sorafenib available for patients with advanced Renal Cell Carcinoma, who have failed prior systemic therapy for advanced disease (i.e. requiring second line treatment), and who do not have access to or are not eligible for other clinical trials with sorafenib and who may benefit from treatment with sorafenib. Patients will be treated orally with 400 mg bid sorafenib on a continuous basis and as a single agent. Patients may continue treatment until Disease Progression, intolerable toxicity, the patients chooses to withdraw consent or the patient is unlikely to benefit any further from treatment. Overall, participation in the study will help determine the following: * Find out if patients receiving Sorafenib will live longer * Find out if Sorafenib helps to slow the worsening of kidney cancer * Find out if Sorafenib has an effect on the tumours Conditions: Carcinoma, Renal Cell Intervention / Treatment: DRUG: Nexavar (Sorafenib, BAY43-9006) Location: Germany, Italy, Netherlands, Spain, Switzerland, Denmark, Belgium, United Kingdom, Sweden, France, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The patient must provide written informed consent prior to receiving BAY 43-9006 * The male or female patient must be at least 18 years of age * The patient must have advanced Renal Cell Carcinoma * The patient must have failed at least one prior systemic established therapy for advanced RCC (e. g. IL-2, IFN-a), or must have been unable to tolerate systemic therapy for advanced RCC, or is deemed by the Investigator to be unsuited for systemic therapy for advanced RCC * A patient, who has received prior systemic and local therapies, must have completely recovered from acute toxicity (i. e. resolved back to CTCAE Grade 1 or less, or is considered as not going to resolve), if any, prior to study entry * The patient must be, in the Investigator's opinion, reasonably likely to benefit from treatment with BAY 43-9006 as a single agent * The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * The patient will not require other systemic anti-cancer chemotherapy, immunotherapy (including monoclonal antibodies) or hormonal therapy, except for bisphosphonates while taking BAY 43-9006 * Both male and female patients must use adequate barrier birth control methods (oral contraceptives, injectable contraceptives, intrauterine devices, condoms, sterilization) during their participation in the protocol. The birth control methods must be used for 4 weeks for female patients and for 3 months for male patients after discontinuation of treatment with sorafenib * For patients, who have had major surgery, the wound must be completely healed prior to receiving BAY 43-9006 treatment (4 weeks) Exclusion Criteria: * Patients who are currently enrolled in or have previously participated in any other sorafenib trial * Patients, who are eligible for or do have access to any other sorafenib clinical trial as to the knowledge of the Investigator * Patients who have a life expectancy of less than 2 months * Patients with metastatic brain or meningeal tumors * Patients are excluded who require any of the following: * Investigational drug therapy during the treatment with sorafenib or within 30 days prior to their first dose of sorafenib * Concomitant Rifampicin * Concomitant St. John's Wort (Hypericum perforatum) Warfarin is allowed; however, for patients receiving concomitant warfarin therapy close monitoring of Prothrombin Time (PT) should be performed (please note that no laboratory data are collected in this study) * Women who are pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days of the start of study drug (please note that no laboratory data are collected in this study) * Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity) * Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTc > 0.45-0.47 second) * Patients with active coronary artery disease or ischemia * Patients with Child-Pugh class C hepatic impairment * Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis * Patients with active uncontrolled hypertension * Patients with recent or active bleeding diathesis * Patients with any medical condition which could jeopardize their safety while taking an investigational drug

Study Objectives The objective of the trial is to compare disease-free survival between adjuvant XELOX alone vs XELOX with concurrent capecitabine and radiotherapy in curatively resected gastric cancer patients with D2 dissection. Conditions: Gastric Cancer Intervention / Treatment: DRUG: Capecitabine, DRUG: Oxaliplatin, RADIATION: Radiotherapy Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Histologically proven gastric cancer; >= D2 resection * Stage T1-4, N+ * 18 <= age <= 75 * Eastern Cooperative Oncology Group 0-2 * No distant metastasis * Adequate bone marrow functions (absolute neutrophil count>= 1,500/ul, blood platelet>= 100,000/ul, haemoglobin>= 10g/dl) * Adequate renal functions(serum creatinine <= 1.5mg/dl) * Adequate liver functions (serum bilirubin <= 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase <= 3 times(normal value) * Written informed consent Exclusion Criteria: * Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer; * Active infection requiring antibiotics; * Pregnant, lactating women; * Psychiatric illness, epileptic disorders; * Concurrent systemic illness not appropriate for chemotherapy; * Resection margin (+); * History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma; * D0, D1 resection;

Study Objectives This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Bendamustine, Lenalidomide and Rituximab (R2-B) in patients with first relapsed/refractory mantle cell lymphoma (MCL) and the efficacy and safety of a maintenance treatment with Lenalidomide for 18 months from the end of R2-B (from month 7 to 24) for those responding to the induction. Conditions: Mantle Cell Lymphoma Intervention / Treatment: DRUG: Bendamustine, Lenalidomide, Rituximab Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patient has a diagnosis of MCL according to the WHO classification; * Patient age is >= 18 years; * Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of <= 2; * Understands and voluntarily signs an informed consent form; * Able to adhere to the study visit schedule and other protocol requirements; * Patients treated with one prior regimen and relapsed, or refractory to front line therapy; front line consolidation with autologous stem cell transplantation is considered to be part of first line therapy; * Patient has at least one site of measurable nodal disease at baseline >= 2.0 cm in the longest transverse diameter as determined by CT scan (MRI is allowed only if CT scan can not be performed). Note: Patients with bone marrow involvement are eligible; * Adequate haematological counts: ANC > 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement by MCL; * Conjugated bilirubin up to 2 x ULN unless due to liver involvement by MCL; * Alkaline phosphatase and transaminases up to 2 x ULN unless due to liver involvement by MCL; * Creatinine clearance >= 30 ml/min; a dose reduction of Lenalidomide for patients with creatinine clearance >= 30 mL/min but < 50 mL/min is planned; * Written informed consent was obtained from the patient prior to any study-specific screening procedures; * Patient has the ability to swallow capsules or tablets; * Life expectancy >= 6 months; * Disease free of prior malignancies (a part MCL) with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast; Exclusion Criteria: * Patients who have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study; * Patient has a history of CNS involvement with lymphoma; * Patients with previous history of malignancies (a part MCL) <= 3 years before study accrual with the exception of currently treated basal cell and squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix; * History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances; * Patient has any other concurrent severe and/or uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol; * Creatinine clearance < 30 ml/min; * Patient has a known history of HIV seropositivity; * Patient has active HBV hepatitis. The following categories of HBV positive patients but with non evidence of active hepatitis may be considered for the study and treated with R2-B (see also Section 8.1.8): * patient is HBsAg + with HBV DNA < 2000 UI/ml (inactive carriers); HBV DNA > 2000 UI/ml is criteria of exclusion; * patient is HBsAg - HBsAb +; * patient is HBsAg - but HBcAb + * Patients with HCV active hepatitis are excluded from the study. Patient with no evidence of active hepatitis and/or advanced chronic liver disease according to liver biopsy or fibro-scan evaluation may be included into the study * Patients have received previous treatment with either Bendamustine and/or Lenalidomide.

Study Objectives The goal of this clinical research study is to find the highest tolerable dose of the combination of erlotinib and pralatrexate that can be given to patients with advanced cancer. The safety of the drug combination will also be studied. Pralatrexate is designed to block the body's ability to make folic acid, a protein that may help cancer tissue to develop and spread. Erlotinib hydrochloride is designed to block proteins that are thought to cause cancer cells to grow. Erlotinib may help slow the growth of tumors. Conditions: Advanced Cancers, Solid Tumors Intervention / Treatment: DRUG: Erlotinib, DRUG: Pralatrexate 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: * Measurable or non-measurable disease. * Patients with advanced cancer should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that improves survival by at least three months. * Patients must be at least 3 weeks after cytotoxic therapy and at least 5 half lives after their previous treatment or 3 weeks, whichever shorter, after biologic therapy. Patients may receive palliative radiotherapy immediately before or during treatment provided that not all target lesions are radiated. * Eastern Cooperative Oncology Group (ECOG) performance status <= 2 (Karnofsky >= 60%). * Patients must have normal organ and marrow function defined as: absolute neutrophil count >=1,000/mL; platelets >=100,000/mL; creatinine < 2.0; total bilirubin < 2.0; ALT(SGPT) <=3 X upper limit of normal (ULN); Exception for patients with liver metastasis: ALT(SGPT) <= 5 X ULN. * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose. * Ability to understand and the willingness to sign a written informed consent document. * For the MTD expansion cohort, patients will be eligible if they meet one of the following criteria: I. Have an epidermal growth factor receptor (EGFR)-sensitive mutation (as G719C in exon 18, E746-A750 in exon 90, L858R in exon 21) and have been previously treated with EGFR inhibitor therapy but have subsequently developed resistance, OR II. Have an EGFR-resistant mutation (as T790M in exon 20), OR III. Do not have an EGFR mutation, but have benefited from EGFR inhibitor therapy (including either >=4 months of stable disease [SD] OR a >= partial response [PR]). * Age >= 12 years Exclusion Criteria: * Patients with uncontrolled concurrent illness, including but not limited to: ongoing or active infection requiring hospitalization; psychiatric illness/social situations that would limit compliance with study requirements. * Exclusion of patients with creatinine >2.0 and bilirubin > 2.0. * Patients with colorectal carcinoma with tumors that demonstrate a Kirsten rat sarcoma (KRAS) mutation. * Pregnant or lactating women. * Patients with a history of bone marrow transplant within the previous two years. * Patients with a known hypersensitivity to any of the components of the drug products. * Patients with major surgery within 30 days prior to entering the study.