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Study Objectives RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer. PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment. Conditions: Brain Tumor, Central Nervous System Tumors, Cachexia, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Unspecified Childhood Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: cyproheptadine hydrochloride, DRUG: megestrol acetate Location: United States, Puerto Rico, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SUPPORTIVE_CARE Allocation: NON_RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

INCLUSION CRITERIA: * Any cachectic patient with weight loss presumed secondary to cancer or cancer related therapy is eligible. Cachexia is defined as having one or more of the following: * documented history of weight loss > 5% * drop in growth rate two or more percentile ranks on standard growth charts, * weight for height less than the tenth percentile. * Patients with newly diagnosed or relapsed cancer of any type, including brain tumors. * Patients who are receiving active or palliative therapy are eligible. * If patients have completed treatment for cancer (surgery, chemotherapy, radiotherapy) within 8 weeks of study registration, they are also eligible. * Patients must be >= 2 years and < 21 years of age at the time of admission to this study. * Patients must have a predicted life expectancy of at least eight weeks. EXCLUSION CRITERIA: * Patients who are currently taking or who have taken Periactin and/or Megace during the past three weeks are not eligible. * Patients receiving corticosteroid or monoamine oxidase (MAO) inhibitor therapy. (Intermittent steroid use is permitted IF you anticipate it will not be administered for more than 7 days in a 4 week period. Calculate anticipated intermittent steroid use in 4-week intervals through the 8-week period during which study agent may be administered (4 weeks for Periactin and potentially 4 weeks for Megace. * Patients who have received parenteral nutrition or tube feedings within 1 week of starting this protocol or patients who are expected to require parenteral nutrition or tube feedings during the 4-week course of this study. * Patients taking dronabinol (Marinol) or other appetite-stimulating medications during the past three weeks or patients expected to be prescribed appetite-stimulating medications during the 4-week course of this study. * Patients with hormone sensitive tumors specifically meningiomas, breast cancer, ovarian cancer, and endometrial carcinoma.31, 32 * Children with neurofibromatosis, type I or II, are at risk for the development of meningiomas and are thus excluded from this study.32 * Children with glaucoma, chronic persistent asthma, or gastrointestinal (GI) or genitourinary (GU) obstruction. * Patients with recurrent and/or persistent hypertension, defined as blood pressure values >20% above normal. * Patients with thromboembolic disease, congestive heart failure, or peripheral edema. * Patients who are pregnant.

Study Objectives Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged \<21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese). Conditions: Adenovirus, Anesthesia, Anxiety, Anxiolysis, Autism, Autistic Disorder, Bacterial Meningitis, Bacterial Septicemia, Benzodiazepine, Bipolar Disorder, Bone and Joint Infections, Central Nervous System Infections, Convulsions, Cytomegalovirus Retinitis, Early-onset Schizophrenia Spectrum Disorders, Epilepsy, General Anesthesia, Gynecologic Infections, Herpes Simplex Virus, Infantile Hemangioma, Infection, Inflammation, Inflammatory Conditions, Intra-abdominal Infections, Lower Respiratory Tract Infections, Migraines, Pain, Pneumonia, Schizophrenia, Sedation, Seizures, Skeletal Muscle Spasms, Skin and Skin-structure Infections, Treatment-resistant Schizophrenia, Urinary Tract Infections, Withdrawal, Sepsis, Gram-negative Infection, Bradycardia, Cardiac Arrest, Cardiac Arrhythmia, Staphylococcal Infections, Nosocomial Pneumonia, Neuromuscular Blockade, Methicillin Resistant Staphylococcus Aureus, Endocarditis, Neutropenia, Headache, Fibrinolytic Bleeding, Pulmonary Arterial Hypertension, CMV Retinitis, Hypertension, Chronic Kidney Diseases, Hyperaldosteronism, Hypokalemia, Heart Failure, Hemophilia, Heavy Menstrual Bleeding, Insomnia Intervention / Treatment: DRUG: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care: Location: Israel, Canada, United Kingdom, United States, Singapore Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * 1) Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver Exclusion Criteria: * 1) Failure to obtain consent/assent (as indicated) * 2) Known pregnancy as determined via interview or testing if available.

Study Objectives The purpose of this study is to determine the feasibility and safety of administering CMV RNA-pulsed dendritic cells (DCs), also known as CMV-DCs, to children and young adults up to 35 years old with nWHO Grade IV glioma, recurrent malignant glioma, or recurrent medulloblastoma. Evidence for efficacy will also be sought. This will be a phase 1 study evaluating CMV-DC administration with tetanus toxoid (Td) preconditioning and Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) adjuvant in children and young adults up to 35 years old with WHO grade IV glioma, recurrent malignant glioma, or recurrent medulloblastoma. This safety study will enroll a maximum of 10 patients. Conditions: Glioblastoma, Malignant Glioma, Medulloblastoma Recurrent, Pediatric Glioblastoma Multiforme, Pediatric Brain Tumor, Recurrent, Pediatric Brain Tumor Intervention / Treatment: BIOLOGICAL: CMV-DCs with GM-CSF, BIOLOGICAL: Td (tetanus toxoid) 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: * Age requirements: 1. <= 35 years for patients with grade IV glioma or recurrent World Health Organization (WHO) grade IV glioma 2. 3-35 years old for patients with recurrent medulloblastoma * Newly diagnosed or recurrent WHO grade IV glioma, recurrent WHO grade III glioma, or recurrent medulloblastoma (multifocal/disseminated disease is eligible, at the discretion of the PI) * Patients with WHO grade IV glioma who received surgery and radiation are eligible even without recurrence or progression * Patients must have recovered from all previous treatments including chemotherapy, radiation therapy, surgery, and other immunotherapies, etc. a. If the patient was receiving bevacizumab at the time of enrollment, the treating oncologist has the discretion of administering and adjusting bevacizumab 10 mg/kg every 14 days. The rationale for continuing patients on bevacizumab is to prevent rebound cerebral edema commonly seen after stopping this agent. * Laboratory Studies: 1. Platelets >= 100,000 cells/mm3 2. Creatinine <= 1.2 x upper limit of normal (ULN) 3. Total bilirubin, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), alkaline phosphatase <= 2.5 x ULN 4. Neutrophil count >= 1000 cells/mm3 5. Hemoglobin >= 9 g/dl prior to biopsy (can be transfused) * Able to undergo brain MRI with and without contrast * Karnofsky Performance Status (KPS) >= 70 or Lansky Performance Status (LPS) >= 70 * A signed informed consent form approved by the Institutional Review Board (IRB) will be required for patient enrollment into the study. Patients (if 18 years old or older) or their parent(s) or guardian(s) (if younger than 18 years old) must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study. * For females of childbearing potential, negative serum pregnancy test within 48 hours of leukapheresis * Females of childbearing potential must be willing to use acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug * Males with female partners of childbearing potential must agree to practice adequate contraceptive methods throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug * Newly diagnosed WHO grade IV glioma patients only: must be expected to complete standard of care radiation (minimum ~54 Gray) Exclusion Criteria: * Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for >= 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible) * Disease outside of the central nervous system (CNS) * Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C seropositive * Known active infection requiring intravenous (IV) antibiotics or active immunosuppressive disease * Severe, active co-morbidity, defined as follows: 1. Unstable angina and/or congestive heart failure requiring hospitalization 2. Transmural myocardial infarction within the last 6 months 3. Acute bacterial or fungal infection requiring intravenous antibiotics at initiation of Radiation Therapy (XRT)/Temozolomide (TMZ) 4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at initiation of XRT/TMZ for newly diagnosed patients or at initiation of dose-intensified (DI) TMZ for recurrent patients 5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects 6. Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive 7. Patients with autoimmune disease requiring medical management with immunosuppressant(s) 8. Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy 9. Active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity * Pregnant or lactating women * Prior allergy to TMZ, GM-CSF, gadolinium (Gd), or Td * Prior history of brachial neuritis or Guillain-Barré syndrome * Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry * Patients receiving > 0.1mg/kg or 4mg/day dexamethasone or equivalent * For recurrent patients only: Patients who have not recovered from the toxic effects of prior chemo- and/or radiation therapy. Guidelines for this recovery period are dependent upon the specific therapeutic agent being used: * Patients who have received chemotherapy or bevacizumab <= 4 weeks [except for nitrosourea (6 weeks) or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)] prior to starting the study drug unless patients have recovered from the side effects of such therapy. If the patient was receiving bevacizumab at the time of enrollment, the treating oncologist has the discretion of administering and adjusting bevacizumab 10 mg/kg every 14 days. * Patients who have received immunotherapy <= 4 weeks prior to starting the study drug unless patients have recovered from the side effects of such therapy

Study Objectives Chronic myeloid leukemia (CML) is a hematopoietic neoplasm characterized by the reciprocal translocation t(9;22). The resulting oncoprotein, bcr-abl is an essential trigger for growth and survival of leukemic cells. In the past decade, the bcr-abl tyrosine kinase inhibitor (TKI) imatinib (IM or Glivec©) has been the standard of care for patients with CML, inducing durable responses. However, requiring continuing IM indefinitely and the ability of IM to eradicate the CML clone was uncertain. In a small proportion of patients, IM can induce complete molecular response (CMR) defined by the disappearance of the bcr-abl transcript in conventional quantitative RT-PCR. The question whether or not these patients are cured and can discontinue drug therapy has been assessed by Mahon and coll, in the STIM study. He demonstrates that IM can be safely discontinued in patient with a CMR of at least 2 year duration and all patients who relapsed after IM discontinuation mainly did it in the first 6 months and responded to reintroduction of imatinib. Nilotinib is a rationally designed second generation tyrosine kinase inhibitor with improved target specificity over imatinib. Its efficacy and safety in the treatment of patients who are resistant or intolerant to imatinib as well as patients with newly diagnosed CML-CP led to the registration in second and first line treatment of CML-CP patients. Nilotinib produces even faster and deeper responses with more occurrence of CMR than does Imatinib. Consequently, one can assume that a more potent drug such nilotinib could induce deeper and sustained CMR allowing longer period off treatment than IM. The objective of this pilot trial is to assess if Nilotinib can rescue STIM patients in molecular relapse after IM discontinuation and to provide an estimation about duration of CMR after nilotinib discontinuation in 2nd line therapy among patients experiencing 2 years of stable CMR with nilotinib. Conditions: Leukemia, Myelogenous, Chronic, BCR-ABL Positive Intervention / Treatment: DRUG: Nilotinib Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male and female patients * Patient participating to the STIM trials (including STIM, STIM2 et EURO-SKI) and with confirmed molecular relapse on two consecutive RQ PCR, after imatinib discontinuation * Still in chronic phase * Not yet treated for this relapse * At least 18 years old (no upper age limit) * SGOT and SGPT < 2.5 UNL * Serum creatinin < 2 UNL * No planned allogeneic stem cell transplantation * Signed informed consent * ECOG score 0 to 2 Exclusion Criteria: * Pregnancy, lactation * Prior or concurrent malignancy other than CML (exceptions to be mentioned) * Serious uncontrolled cardiovascular disease * Severe psychiatric/neurological disease (previous or ongoing) * Ongoing treatment at risk for inducing "torsades de pointe" * QTcF > 450ms despite correction of predisposing factors (i.e electrolytes...) * Congenital long QTcF * No health insurance coverage

Study Objectives This is a multi center, open-label study to evaluate the drug-drug interaction of LDE225 on the PK of bupropion and warfarin patients with advanced solid tumors. Subjects will receive 800mg daily of LDE225 and two separate doses of either bupropion or warfarin. Conditions: Advanced Solid Tumor Intervention / Treatment: DRUG: LDE225, DRUG: Wafarin, DRUG: Bupropion Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Adults * Patients with cytopathologically or histopathologically confirmed diagnosis of an advanced solid tumor which has progressed despite standard therapy, or for which no standard therapy exists or patients with locally advanced or metastatic basal cell carcinoma who are not amendable or eligible for standard therapy. * Protocol-defined renal , liver and bone marrow function Exclusion Criteria: * CNS (Central Nervous System) tumors as well as history of brain metastases * Systemic anticancer treatment (including biologic therapy/antibodies) within 2 weeks before first dose of study treatment (6 weeks for nitrosourea, mitomycin, and monoclonal antibodies). * Radiation therapy within 4 weeks before first dose * Investigational agents within 4 weeks before start of study therapy * Patients with known allergy/hypersensitivity to warfarin or bupropion and/or related compounds * Patients with a history of/or active bleeding disorders * Patients receiving treatment with vitamin K, Coumadin or other agents containing warfarin and heparin. Heparin flush to maintain patency of a central venous access device is allowed. * Patients receiving treatment with bupropion. * Patients who have neuromuscular disorders that are associated with elevated CK (Creatine phosphokinase) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy). * Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B or C (testing is not mandatory for study entry) * Patients currently receiving systemic corticosteroids Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back. Conditions: Acute Myeloid Leukemia, Acute Myeloid Leukemia With Myelodysplasia-Related Changes, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A, Untreated Adult Acute Myeloid Leukemia Intervention / Treatment: PROCEDURE: Autologous Bone Marrow Transplantation, PROCEDURE: Autologous Hematopoietic Stem Cell Transplantation, DRUG: Busulfan, DRUG: Cytarabine, DRUG: Daunorubicin Hydrochloride, DRUG: Decitabine, DRUG: Etoposide, BIOLOGICAL: Filgrastim, OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study 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: * Unequivocal histologic diagnosis of AML (> 20% blasts in the bone marrow based on the World Health Organization [WHO] and/or French American British [FAB] classifications), excluding M3 (acute promyelocytic leukemia); patients with antecedent myelodysplasia are eligible for treatment on this trial only if there were no bone marrow biopsy showing myelodysplastic syndrome (MDS) > 3 months prior to enrollment; patients with therapy-related AML are eligible if they have been free of their primary disease and have not received any chemotherapy for at least 2 years * No prior 5-azacitidine or decitabine therapy * No prior treatment for leukemia or myelodysplastic syndrome with four permissible exceptions: * Emergency leukapheresis * Emergency treatment for hyperleukocytosis with hydroxyurea * Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only) * Growth factor/cytokine support

Study Objectives The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot be treated with cisplatin. This study will help to determine whether vinflunine in combination with gemcitabine will extend the time period until further growth of the tumor more than gemcitabine alone. Conditions: Bladder Cancer, Transitional Cell Carcinoma, Metastasis Intervention / Treatment: DRUG: Vinflunine, DRUG: Gemcitabine, OTHER: Placebo Location: Indonesia, Canada, Korea, Republic of, Thailand, Italy, Spain, United Kingdom, Denmark, United States, Belgium, Australia, Greece, Philippines, Russian Federation, France, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic * Ineligible for cisplatin-based therapy because of at least one of the following two medical conditions: * Calculated creatinine clearance <=60 mL/min: OR * New York Heart Association Classification Stage III-IV Congestive Heart Failure * Measurable disease documented by imaging with at least one uni-dimensional lesion * Adequate performance status (ECOG 0, 1, or 2) * Men and women >=18 years of age Exclusion Criteria: * Patients in whom radiation or surgery is indicated * Current neuropathy >= CTCAE grade 3 * Prior radiation to >= 30% of bone marrow * Inadequate renal function: serum creatinine clearance <= 20 mL/min * Prior allergy to any vinca alkaloid

Study Objectives Currently, there are no telemedical visits between patients and/or their relatives and a palliative physician for the evaluation of symptom and progress monitoring. This is done during visits of the patient by the coordinators and palliative physicians of the palliative network/PKD Münster (PKD = Palliative Care Consultation Service) and/or the general practitioners. Upon enrollment in the Palliative Network/PKD Münster, patients receive a 24-hour emergency telephone number. This is staffed by a caregiver who coordinates the deployment of other caregivers / palliative care physicians according to the information provided by the patient / family members. If patients are randomized to the "telemedicine" group, they have the option of using ELVI (ELVI = electronic visit) in addition to conventional care, and thus the possibility of televisits with physicians or nurses. In this case, they receive access data for ELVI, i.e., an access code for a virtual waiting room. In addition, patients will be given questionnaires at discharge to be completed on the day of discharge and on days 7, and 14. The primary objective of this randomized trial is to demonstrate that telemedically managed patients are not relevantly inferior to conventionally managed patients in terms of change in Integrated Palliative care Outcome Scale (IPOS) from the day of discharge (non-inferiority question), although the possibility of televisiting may result in less frequent physician visits to the patient's home. Conditions: Cancer, Chronic Heart Failure, Chronic Obstructive Pulmonary Disease, Palliative Care Intervention / Treatment: OTHER: Telemedicine Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with indications to receive specialized palliative care for advanced malignant and non-malignant diseases * Minimum age 18 years * Signed informed consent * Inpatient care in a normal ward or the palliative care unit at University Hospital Muenster * Planned discharge to home environment * Consent to participate in randomized study * Residence in the area of responsibility of the palliative care network/PKD Münster and consent to the Connection to the palliative care network/PKD Münster * At least one cell phone (or comparable device with camera and microphone) with wireless network connection or long data evolution (LTE) flat rate * Basic willingness to use new media * Disease phase "stable" / "unstable" / "deteriorating" (patients who are in the dying phase are not included in the randomized part of the study, as they will in all likelihood not be discharged home). Exclusion Criteria: * Pregnant or breastfeeding patients * minors * Language difficulties (lack of German language skills), if these cannot be compensated by family members or interpreters can be compensated * Dependency or employment relationship to the project management or the including physician * Persons who have been placed in an institution by court or official order

Study Objectives The study objective is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) five elements music therapy improving quality of life for patients with advanced cancer, as well as establishing the standard operating procedures (SOP) for it. Conditions: Cancer Intervention / Treatment: OTHER: music Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Eligible participation will be enrolled based on diagnostic criteria. * Advanced cancer patient with more than 50 scores of Karnofsky Performance Score (KPS). * Diagnosis of advanced cancer * Patients who are willing to be subject with taking part in this research voluntarily. * No prior experience with TCM music therapy. * Newly admitted to TCM oncology department for 3 weeks treatment course. Exclusion Criteria: * Complicated diagnose or one who don't consistent with inclusion criteria. * Patients suffering from psychosis or diagnosis, or psychiatric diagnoses (e.g., schizophrenia). * Suffering from acute organ prostration or other condition of demanding to rescue，inability for accepting music therapy. * One don't read or fill in diary owing to some causes, such as state of the art or acuity of vision * One suffering from hearing disturbance * Accepted TCM five elements music therapy in the past.

Study Objectives The purpose of this study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Degarelix, DRUG: Degarelix, DRUG: Leuprolide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * >= 18 years. * Raising PSA after prior treatment failure of localized prostate cancer. * Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy. * Has a screening testosterone within normal range (>=1.5 ng/mL). * Has Eastern Cooperative Oncology Group score of <=2. * Bone scan or CT scan report documenting no evidence of metastasis to the bone or internal organs. * Life expectancy of at least 15 months. Exclusion Criteria: * Taken hormone therapy in the last 6 months prior to entering this study. * Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a stable dose throughout the trial. * Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema. * Has hypersensitivity towards any component of the study drug. * Has a previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin within the last five years. * Has abnormal laboratory results which in the judgement of the Investigator would affect the patient's health or the outcome of the trial. * Has a clinically significant medical condition (other than prostate cancer) including but not limited to; renal, haematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator. * Has an intellectual incapacity or language barriers precluding adequate understanding or co-operation. * Has received an investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of the current trial. * Has received ketoconazole or diflucan in the last 28 days preceding the Screening Visit. * Has previously participated in any Degarelix trial. * Is part of an ongoing trial.

Study Objectives Primary Objective: * To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4). * To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses. Secondary Objectives: * To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in Segment 1 * To characterize the safety and tolerability of 28-day consecutive doses of 500 mg SAR302503 in Segment 2 * To determine antitumor activity in Segment 2 Conditions: Solid Tumor Intervention / Treatment: DRUG: SAR302503, DRUG: omeprazol, DRUG: metoprolol, DRUG: midazolam Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion criteria : * Histologically or cytologically confirmed advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist * Signed informed consent Exclusion criteria: * Less than 18 years of age. * Limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale) * Inability to follow study requirements and schedule * Treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other anti-cancer therapy * Serious medical illness at same time of study and/or significantly abnormal lab reports * Lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding. * Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug * Continued toxic effects of prior chemotherapy * Evidence of other concurrent active malignancy * Other concurrent serious illness or medical condition * Cardiac abnormalities include bradycardia, AV block or other conduction defect on ECG, and patients taking a beta blocker. * Patients with Insulin-Dependent Diabetes Mellitus. * Patients with known active (acute or chronic) hepatitis A, B, C, and hepatitis B and C carries. Prior history of chronic liver disease (e.g., chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH]). * Inadequate organ function * History of partial or total gastrectomy, or, if in the opinion of the investigator, have any other disorder that would inhibit absorption of oral medications. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives This phase I/II trial studies the side effects and best dose of cetuximab when given together with pembrolizumab in treating patients with colorectal cancer that has spread from the primary site (place where it started) to other places in the body (metastatic) or that cannot be removed by surgery. Monoclonal antibodies, such as cetixumab and pembrolizumab, may block tumor growth in different ways by targeting certain cells. Conditions: Recurrent Colorectal Carcinoma, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer Intervention / Treatment: BIOLOGICAL: Cetuximab, OTHER: Laboratory Biomarker Analysis, BIOLOGICAL: Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Have a pathologically confirmed diagnosis of colorectal cancer, which is metastatic or otherwise unresectable * Have received at least 1 prior systemic therapy in the metastatic or unresectable disease setting; patients who have recurred within six months of adjuvant chemotherapy are not required to have received an additional line of chemotherapy * Retrovirus-associated deoxyribonucleic acid (DNA) sequence (RAS) wild-type; v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) testing must be completed, with full KRAS and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) testing strongly advised; the presence of known mutations in KRAS or NRAS is exclusionary; primary tumor or metastatic tumor may be tested; (note: in the case of multiple genomic evaluations with conflicting results - e.g. KRAS mutant in one sample, but wild-type in another - the patient may be included as RAS wild-type, if clinically justified, after review with the principal investigator [PI]) * Appropriate for anti-EGFR therapy: Naive to anti-EGFR therapy (cetuximab or panitumumab) or a candidate for rechallenge by virtue of the following: 1. the investigator deems anti-EGFR retreatment with cetuximab to be a reasonable standard of care option AND 2. outcome of prior anti-EGFR therapy was not rapid progression (i.e. <= 3 months on therapy) AND 3. prior anti-EGFR therapy was administered > 6 months prior to the start of protocol therapy * Have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2 * Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present * Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion; newly-obtained is defined as a specimen obtained up to 30 days prior to initiation of treatment on day 1 * Hemoglobin >= 8 g/dL (performed within 14 days of treatment initiation) * Absolute neutrophil count >= 1000/mm3 (performed within 14 days of treatment initiation) * Platelet count >= 100,000/mm3 (performed within 14 days of treatment initiation) * Serum creatinine =< 2 upper limit of normal (ULN) or, >= 15 mL/min for participants with creatinine levels > 2 ULN (performed within 14 days of treatment initiation) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 ULN or, =< 5 ULN for participants with liver metastases (performed within 14 days of treatment initiation) * Female participants of childbearing potential are to have a negative serum pregnancy test * Female participants of child-bearing potential must agree to use an acceptable method of birth control, be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy * Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Participants who have had chemotherapy, targeted therapies, radiotherapy, or used an investigational device within 2 weeks prior to the first dose of treatment or those who have not recovered from adverse events (i.e., =< grade 1 or at baseline) due to agents administered more than 2 weeks earlier; note: participants with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment * Has a known history of active TB (Bacillus Tuberculosis) * Hypersensitivity to pembrolizumab or any of its excipients * Prior severe infusion reaction to cetuximab * Has a known additional malignancy that requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability * Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment * Has known history of, or any evidence of active, non-infectious pneumonitis * Uncontrolled clinically significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness, substance abuse disorders or social situations that would limit compliance with study requirements * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment * Has a known history of human immunodeficiency virus (HIV or HIV 1/2 antibodies); testing not required * Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected); testing not required * Has received a live vaccine within 30 days of planned start of study therapy (note: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and shingles are not allowed) * Received an investigational agent within 30 days prior to starting study treatment * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator * Unwilling or unable to follow protocol requirements

Study Objectives This is a non-randomized, open-label, single-institution phase I/II therapeutic trial of bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC). This study will be activated at the UT Southwestern Medical Center, comprised of The Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Hospitals-St. Paul and Parkland Memorial Hospital System. Advanced HCC is defined as disease that is not amenable to surgical resection or orthotopic liver transplantation or is metastatic in nature. Conditions: Hepatocellular Carcinoma, Liver Cancer Intervention / Treatment: DRUG: bavituximab (0.3 mg/kg) and sorafenib, DRUG: bavituximab (1.0 mg/kg ) and sorafenib, DRUG: bavituximab (3.0 mg/kg) and sorafenib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below: * Histologically confirmed. * MRI or CT consistent with liver cirrhosis and at least one solid liver lesion >2 cm with early enhancement and delayed enhancement washout regardless of AFP. * AFP >400 ng/ml and evidence of at least one solid liver lesion >2 cm regardless of specific imaging characteristics on CT or MRI. * Locally advanced or metastatic disease. * Patients with locally advanced disease must have disease deemed to be unresectable or not eligible for hepatic transplantation. Determination will occur in the weekly GI DMT meeting by surgical oncologists and transplant surgeons. * Measurable disease, as defined as lesions that can accurately be measured in at least one dimension (longest diameter to be measured) according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at least 2 cm with conventional techniques or at least 1 cm with spiral computed tomography. * Child-Pugh Score A. * Age >= 18 years. * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2. * Absolute neutrophil count >= 1,500 cells/mm3. * Platelet count >= 75,000 cells/mm3. * Total bilirubin <= 3.0 mg/dl. * Hemoglobin >= 8.5 g/dl. * AST and ALT <= 5.0 times upper limit of normal. * D-dimer <= 3 times upper limit of normal. * INR <= 1.8 (therapeutic anticoagulation allowed as long as medically indicated. Exclusion Criteria: * History of bleeding diathesis or coagulopathy. * Symptomatic or clinically active brain metastases. * Major surgery within previous 4 weeks. * History of thromboembolic events (including both pulmonary embolisms and deep vein thrombosis); central venous catheter-related thrombosis > 6 months prior is allowed. * Prior adjuvant therapy with sorafenib or other Raf/MEK/RAS or VEGFR inhibitors. Prior adjuvant therapy is allowed provided it was completed > 6 months ago and there is documented recurrence of hepatocellular carcinoma.

Study Objectives Advanced colorectal cancer (ACRC) is a heterogeneous disease and classification of patients is nowadays inefficient. Roughly twenty per cent of patients present with favorable figures (less than 4 liver nodules and less than 5 cm) and are suitable for local treatments (surgery or local-ablative therapies). Additionally, 10-15% of patients have poor performance status (PS \>2) or are severe disabled due to geriatric syndromes or/and co-morbid diseases that preclude any treatment strategies than best supportive care alone. The rest of patients (fit patients not suitable for radical treatments) constitute the population of patients treated with palliative therapies. Despite of it not all these patients have the same prognosis. Patients with PS 0,1 and levels of LDH \<ULN (Intermediate-risk patients) have better PFS and OS irrespective of therapy in all randomized clinical trials (de Gramont et al, JCO 2000; Douillard et al, Lancet 2000; Koopman et al, 2007). CRYSTAL trial shows a benefit in PFS (1.5 months) in RASWT of FOLFIRI plus cetuximab compared with FOLFIRI alone. Nowadays the selection of patients for cetuximab treatment is based on mutational status of KRAS, which allow to select those patients who will not respond to therapy. Other surrogate markers of activity should be also evaluated. Our hypothesis is that the suggested biomarkers will allow the selection of the patients who will benefit the most from the biweekly cetuximab treatment. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: FOLFIRI (m), DRUG: FOLFOX-6 (m), DRUG: Cetuximab Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SCREENING Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female, age >= 18 years * Able to sign an informed consent form * Advanced and/or metastatic colorectal cancer * Colorectal cancer with KRAS wild type genotype * At least one unidimensionally measurable lesion according to RECIST criteria (1.1 revised) (to be assessed <= 28 days prior to the study treatment) * All patients with the following features will be included: 1. Progression free survival > 6 months after adjuvant treatment +/- radiotherapy 2. "De novo" diagnosis of the disease * Performance ECOG status of 0-2 * Life expectancy >= 3 months * Adequate bone marrow function: neutrophils >=1,5 x 10^9/L; platelets >= 100 x 10^9/L; hemoglobin >=9 g/dL. * Adequate liver, renal and hematological function as follows: 1. Adequate liver function: SGOT and SGPT 2.5 x ULN (5 x ULN in case of hepatic metastasis). Total bilirubin < 1,5 x ULN. Alkaline phosphatase 2,5 x LSN (5 x ULN if hepatic metastasis or 10 x ULN if bone metastasis) 2. Creatinine clearance or creatinine clearance during 24 hours >= 50 mL/min 3. Magnesium >= LLN, calcium >= LLN Exclusion Criteria: * PS > 2 or elderly patients with fragility criteria * Previous surgery for metastasis * Previous systemic treatment for the metastatic colorectal cancer * Previous treatment with antibodies anti-EGFR or treatment with small-molecule EGFR tyrosine kinase inhibitors or EGFR signal transduction inhibitors. Subjects who suspend their first dose due to a reaction to the infusion can participate * Central nervous system metastasis (except: treated subjects with asymptomatic CNS metastasis who have not received steroids within the 30 days prior to inclusion) * Prior malignant tumor in the last 5 years, except: basal cell carcinoma of the skin or pre-invasive cervical cancer * Unresolved toxicities from a prior systemic treatment which do not qualify the patient for inclusion * Presence of peripheral neuropathy (degree > 1 in the ctc version 3.0) and serious nonhealing wound, ulcer, or bone fracture * Hormonal treatment, immunotherapy or experimental or approved antibodies/proteins <= 30 days before the inclusion * Uncontrolled serious cardiovascular disease or: congestive cardiac failure NYHA lll or lV, unstable angina pectoris, myocardial infarction precedents in the past 12 months, significant arrhythmias * Interstitial pneumonitis or pulmonary fibrosis precedents, or interstitial pneumonitis or pulmonary fibrosis signs on the thoracic CT-scan * Treatment for systemic infection within the 14 days prior to treatment * Acute/subacute intestinal occlusion and/or active inflammatory bowel disease or any other bowel disease producing chronic diarrhea * Precedent of Gilbert's syndrome or dihydropyrimidine dehydrogenase deficiency * Precedent of any disease which can increase the risks associated to the participation in the study or interfere in the study results * Known positive test for the following infections: HIV, Hepatitis C + abnormal liver enzymes values, active chronic Hepatitis B (except Hepatitis C seropositive with normal liver enzymes) * All concurrent diseases which can increase the toxicity risk * The individual presents a disorder of any kind which jeopardizes their ability to give their written consent form and/or fulfill the study procedures * Any investigational agent within 30 days before enrolment * Pregnant or breastfeeding woman, or planning to get pregnant within the 6 months after treatment * Surgery (excluding the diagnostic biopsy or placing of a central venous catheter) * Woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the study and 6 months after de last administration for women, and 1 month for men * Unability to fulfill the study requirements by the patients * Psychological, family, sociological or geographical conditions that may interfere with the fulfillment of the study protocol and the follow-up calendar

Study Objectives The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: YM155, DRUG: Docetaxel Location: Germany, Czech Republic, United Kingdom, United States, Belgium, Ireland, Russian Federation, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically- or cytologically-proven adenocarcinoma of the breast that is HER2 negative. Subjects with hormone receptor positive or negative status are eligible. Additionally, subjects with triple negative status (meaning estrogen receptor negative, progesterone receptor negative and HER2 negative) are eligible * No prior chemotherapy regimen for metastatic breast cancer * Eastern Cooperative Oncology Group (ECOG) performance status <= 1 at the Baseline Visit * The subject's life expectancy is estimated to be > 12 weeks at the Baseline Visit * The subject must be non-pregnant and non-lactating. All sexually active subjects of childbearing potential must agree to use an adequate method of contraception throughout the study period Exclusion Criteria: * Hypersensitivity to docetaxel or polysorbate 80 * Neuropathy >= Grade 2 at the Baseline Visit * Known brain or leptomeningeal metastasis as assessed through medical history review and physical examination * The subject has known Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen or hepatitis C antibody

Study Objectives This is a pilot study to assess the safety and measure image-based absorbed dose of 177Lu-P17-087/177Lu-P17-088 in patients with metastatic castration-resistant prostate cancer (mCRPC) who will undergo radioliagnd therapy using 177Lu-P17-087/177Lu-P17-088. All patients underwent whole-body 68Ga-PSMA PET/CT for selection and accepted intravenous injection with single dose 1.1 GBq (30 mCi) of 177Lu-P17-087/177Lu-P17-088 within one week, then monitored at 1.5 hours, 4 hours, 24 hours, 48 hours, 72 hours, 120 hours and 168 hours after 177Lu-P17-087/177Lu-P17-088 administration with serial whole body planar and SPECT/CT imaging. Conditions: Metastatic Castration-resistant Prostate Cancer Intervention / Treatment: DRUG: 1.1 GBq (30 mCi) of 177Lu-P17-087, DRUG: 1.1 GBq (30 mCi) of 177Lu-P17-088 Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * All the patients had progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy; * Distant metastases with high PSMA expression were confirmed on 68Ga-PSMA PET/CT within one week before the injection of 177Lu-P17-087/177Lu-P17-088. Exclusion Criteria: * Patients were excluded if they had [18F]FDG positive tumors without corresponding PSMA uptake. Patients were also not eligible if they accepted other radionuclide therapies within 6 months or had clinically significant impaired bone marrow, liver, or kidney function with a hemoglobin level of less than 9.0 g/dL, a white blood cell count of less than 2.5×109/L, a platelet count of less than 100×109/L and a serum creatinine > 100 μmol/L.

Study Objectives The purpose of this study is to evaluate the safety, and tolerability of HLA-A\*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine Conditions: Pancreatic Cancer Intervention / Treatment: BIOLOGICAL: VEGFR1-1084, VEGFR2-169, DRUG: Gemcitabine Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: DISEASE CHARACTERISTICS * Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer * Measurable disease by CT scan PATIENTS CHARACTERISTICS * ECOG performance status 0-2 * Life expectancy > 3 months * Laboratory values as follows: * 2,000/mm3 < WBC < 15000/mm3 * Platelet count >= 750,000/mm³ * Total Bilirubin <= 1.5 x * Aspartate transaminase < 150 IU/L * Alanine transaminase < 150 IU/L * Creatinine <= 3.0 mg/dl * HLA-A*2402 * Able and willing to give valid written informed consent Exclusion Criteria: * Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) * Breast-feeder * Active or uncontrolled infection * Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks * Serious or uncured wound * Active or uncontrolled other malignancy * Steroids or immunosuppressing agent dependent status * Interstitial pneumonia * Ileus * Decision of unsuitableness by principal investigator or physician-in-charge

Study Objectives Primary Objectives: 1. To determine the efficacy of administering multiple doses of intravenous (i.v.) busulfan at a dose of 130 mg/m2, to yield a systemic plasma drug exposure represented by a daily area under the plasma concentration versus time curve (AUC) of approximately 5,000 mMol-min for 4 days, followed by i.v. melphalan at a dose of 70 mg/m2 for 2 days in adult patients receiving autologous or allogeneic transplantation for lymphoid malignancies or myeloma. 2. To describe the plasma pharmacokinetic (PK) profiles of busulfan and melphalan in this regimen. 3. To determine the disease-free and overall survival of patients receiving this preparative regimen. 4. To determine the treatment-related morbidity and mortality of this combination of drugs. Conditions: Multiple Myeloma, Lymphoma Intervention / Treatment: DRUG: Busulfan, DRUG: Melphalan 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 lymphoid malignancies, including Hodgkin's and non-Hodgkin's lymphoma (primary refractory or recurrent), or multiple myeloma (beyond first complete remission or unresponsive to therapy. Complete remission for multiple myeloma defined by absence of detectable paraprotein in serum and/or urine by immunoelectrophoresis or immunofixation, and < 5% plasma cells in the bone marrow), not qualifying for treatment protocols of higher priority. * Age 18 to 65 years of age. * Adequate renal function as defined by estimated serum creatinine clearance > 50 ml/min and serum creatinine < 1.8 mg/dL. * Adequate hepatic function, as defined by serum glutamic pyruvic transaminase (SGPT) < 3 * upper limit of normal; serum bilirubin and alkaline phosphatase < 2 * upper limit of normal, or considered not clinically significant. * Adequate pulmonary function with Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and Capacity of the Lung for Carbon Monoxide (DLCO)> 50%. Exceptions may be allowed for patients with pulmonary involvement after discussing with principal investigator (PI). * Adequate cardiac function with left ventricular ejection fraction >= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease. * Zubrod performance score < 2. * Patients receiving an allogeneic transplant must have an HLA matched, or one A, B, or DR mismatched related donor. Unrelated donor must be matched at A, B, and DR (defined as A, B serologic matched and DRB1 molecular matched). Donor must be willing to donate peripheral blood or bone marrow progenitor cells. * Patient and donor should be willing to participate in the study by providing written consent. * Female patient must not be pregnant and have negative pregnancy. Exclusion Criteria: * Patients with unresolved grade >= 3 non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the PI. * Patients with active Central Nervous System (CNS) disease. * Evidence of acute or chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy. * Uncontrolled infection, including Human immunodeficiency virus (HIV) or Human T-lymphotropic virus Type I (HTLV-1) infection. * Patients who have had a previous autologous or allogeneic stem cell transplant during the past year.

Study Objectives This is a prospective Belgian, multi-center, open-label, single-arm phase II study of weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer to evaluate tumor response in the breast and the axilla. Conditions: Breast Cancer Intervention / Treatment: DRUG: Paclitaxel, DRUG: Carboplatinum, DRUG: Epirubicin, DRUG: Cyclophosphamide Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Stage II-III operable triple negative (ER and PR < 10%; Her2 IHC 0-1 or FISH <2.0) breast cancer in women age > 18. For patients aged >= 65 years the G8 geriatric screening test should be > 14 (on a total of 17). * Baseline mammography, US. MR of the breast on clinical indication. * FNA of suspicious axillary lymph node is indicated * Pre-treatment SN biopsy is indicated in clinical N0 * Measurable loco-regional disease * Adequate bone marrow function, defined as * Absolute neutrophil count(ANC) >1500*109/L * Platelet count >100.000*109/L * Adequate liver function defined as * Serum(total) bilirubin <1.5*upper limit of normal(ULN), unless the patient has documented Gilbert's Syndrome * AST and/or ALT <2.5*ULN * Alkaline phosphatase <2.5*ULN * Normal cardiac function measured by ultrasound with a left ventricular function > 55% * Creatinine clearance > 40 ml/min according to local laboratory standard (MDRD, CDK-epi, Cockroft-Gault, or other established formula to calculate renal function) Exclusion Criteria: * T4d breast tumor * Bilateral breast cancer * Other invasive cancer in the past except for a localized squamous cell cancer or basal cell of the skin or an in situ squamous cell cancer of the cervix. * Pregnant or lactating patients

Study Objectives This study was a single-arm, open-label, phase II study of PD-1 monoclonal antibody combined with anlotinib in the treatment of advanced non-small cell lung cancer (NSCLC) with EGFR uncommon mutations. Twenty-one patients of NSCLC harboring rare EGFR mutations after previous treatments, including a platinum-based regimen and a targeted treatment (regardless of EGFR Ex20ins), were enrolled. Patients received sintilimab (anti-PD-1) combined with anlotinib (multi-target anti-angiogenesis). The primary endpoint was the objective response rate (ORR) based on RECIST 1.1. Secondary goals included progression-free survival (PFS), overall survival (OS), disease control rate (DCR) based on RECIST 1.1; safety Sex and tolerance. Exploratory objectives include the use of tumor tissue and plasma specimens to detect biomarkers predicting the efficacy of sidilimumab: including but not limited to tumor mutation burden (TMB), PD-L1 expression, etc.; exploring potential predictions in peripheral blood. Biomarkers for anti-group efficacy, including but not limited to TCR. Conditions: Lung Cancer Intervention / Treatment: DRUG: sintilimab and anlotinib Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Sign written informed consent before any trial-related processes are implemented; * Age >= 18 years old and <= 75 years old; * Life expectancy exceeds 3 months; * The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if it is confirmed to have progressed; * Patients with treated metastatic or recurrent (stage IV) NSCLC confirmed by histology or cytology according to the International Association for the Study of Lung Cancer and the American Association for the Classification of Cancer Classification, 8th edition; * The Eastern Cancer Cooperative Group (ECOG) has a fitness status score of 0 or 1; * Patients with genetic testing (allowing PCR and NGS detection methods) confirmed uncommon mutations (EGFR G719X, L861Q, S768I, and 20ins et al.), patients can accept two or more types of EGFR rare co-mutation. Populations with the primary EGFR T790M mutation can also be included in the study. * Patients who have experienced disease progression after at least two treatment regimens for advanced/metastatic disease must include a platinum-containing systemic chemotherapy and an EGFR-TKI treatment. Patients with EGFR 20ins who have experienced disease progression only after platinum-containing systemic chemotherapy. * Hematological function is sufficient, defined as absolute neutrophil count >=1.5×109 /L, platelet count >=100 ×109 /L, hemoglobin >=90g/L (no history of blood transfusion within 7 days); * Hepatic function is adequate, defined as all patients with total bilirubin levels <= 1.5 times normal upper limit (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <= 2.5 times ULN, or for patients with liver metastases , AST and ALT levels <= 5 times ULN; * adequate renal function, defined as creatinine clearance >= 45 ml/min (Cockcroft-Gault formula); * Coagulation function is adequate, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; if the subject is receiving anticoagulant therapy, as long as the INR or PT is within the range of anticoagulant drugs can; * Female subjects of childbearing age should be negative for urine or serum pregnancy test within 3 days prior to receiving the first study drug. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required; * If there is a risk of conception, male and female patients need to use high-efficiency contraception (ie, an annual failure rate of less than 1%) and continue until at least 180 days after stopping the trial treatment; Note: If abstinence is normal for the subject Lifestyle and preferred methods of contraception can be used as a method of contraception. Exclusion Criteria: * Histology is NSCLC, if there are small cell carcinoma, neuroendocrine carcinoma, sarcoma components, it can not be included; * Patients with known EGFR-sensitive mutations (19-Del and L858R); * Cavity lung squamous cell carcinoma, or non-small cell lung cancer patients with hemoptysis (>50 mL/day); * Patients whose tumor has invaded an important blood vessel or who is judged by the investigator to have major bleeding during the follow-up study; * Patients with any signs or history of bleeding physique; * Currently participating in interventional clinical research treatment, or receiving other research drugs or research equipment within 4 weeks prior to the first dose; * Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or against another stimulus or synergistic inhibition of T cell receptors (eg CTLA-4, OX-40, CD137) drug; * Received a proprietary Chinese medicine or immunomodulatory drug (thymosin, interferon, interleukin, etc.) with anti-cancer indications within 2 weeks before the first dose, or received major surgery within 3 weeks before the first dose; * Received a physical organ or blood system transplant; * There is clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not need drainage or stop drainage and have no significant increase in 3 days of effusion can be enrolled); * The tumor compresses important organs (such as the esophagus) around it and is accompanied by related symptoms, oppression of the superior vena cava or invasion of the mediastinal vessels, heart, etc.; * Class III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias; * Any arterial thrombosis, embolism or ischemia occurred within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack. A history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to enrollment (implanted IV port or catheter-derived thrombosis, or superficial vein thrombosis is not considered a "serious" thrombosis embolism); * It is known that there is an allergic reaction to the active ingredient of sindril mAb and or any excipients; * Active autoimmune diseases requiring systemic treatment (eg, using disease-modifying drugs, corticosteroids or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (such as thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments; * Patients who require long-term systemic use of corticosteroids. Patients with intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroids due to COPD or asthma may be enrolled. * has not fully recovered from toxicity and/or complications caused by any intervention prior to initiation of treatment (ie, <=1 or baseline, excluding fatigue or alopecia); * diagnosis within 5 years prior to initial dosing For other malignancies, it does not include radical cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ. If more than 5 years before the drug is diagnosed as other malignant tumors or lung cancer, pathological or cytological diagnosis of recurrent metastatic lesions is required; * symptomatic central nervous system metastasis. For patients with asymptomatic brain metastases or brain metastases with stable symptoms after treatment, as long as all the following criteria are met, participate in this study: measurable lesions outside the central nervous system; no midbrain, pons, cerebellum, meninges, Medulla or spinal cord metastasis; maintain clinical stability for at least 2 weeks; stop hormone therapy 14 days before the first study drug; * One year before the first dose, a history of non-infectious pneumonia requiring corticosteroid treatment or the presence of non-infectious pneumonia; * active infections requiring treatment or systemic anti-infectives used within one week prior to first administration; * There are known cases of mental illness or substance abuse that may have an impact on compliance with the test requirements; * A history of human immunodeficiency virus (HIV) infection (ie, HIV 1/2 antibody positive), known syphilis infection (positive syphilis antibody), and active tuberculosis are known. * Untreated active hepatitis B; Note: Hepatitis B subjects meeting the following criteria are also eligible for inclusion: The HBV viral load must be <1000 copies/ml (200 IU/ml) or below the lower limit of detection before the first dose. Subjects should receive anti-HBV treatment during the entire study chemotherapy drug treatment to avoid viral reactivation. For subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but viral reactivation is closely monitored; * Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection); * Vaccination with live vaccine within 30 days prior to first dose; Note: Injectable inactivated virus vaccine for seasonal influenza is permitted; however, live attenuated influenza vaccine for intranasal administration is not permitted; * There are medical history, disease, treatment, or laboratory abnormalities that may interfere with the test results, hinder the subject's full participation in the study, or the investigator believes that participating in the study is not in the best interest of the subject. * Local or systemic diseases caused by non-malignant tumors, or secondary reactions to cancer, and may lead to higher medical risks and/or uncertainty in survival assessment.

Study Objectives Protocol B8011001 is a Phase 1, open-label, multi-center, multiple-dose, dose escalation and expansion, safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 in previously treated adult patients with locally advanced or metastatic melanoma, SCCHN, ovarian carcinoma, sarcoma, NSCLC, urothelial carcinoma or other solid tumors. This is a 2 Part study whereby the safety and tolerability of increasing dose levels of intravenous (IV) or subcutaneous (SC) PF-06801591 was assessed in Part 1. Part 2 expansion is designed to further evaluate the safety and efficacy of SC PF-06801591 in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose. Conditions: Part 1, MELANOMA, SCCHN, OVCA, SARCOMA, OTHER SOLID TUMORS, Part 1 and 2, NSCLC, UROTHELIAL CARCINOMA Intervention / Treatment: DRUG: PF-06801591, DRUG: PF-06801591 Location: Bulgaria, Malaysia, Korea, Republic of, Ukraine, United States, Russian Federation, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Masking: NONE

Inclusion Criteria (Part 2 Only): * Histological or cytological diagnosis of locally advanced or metastatic NSCLC or urothelial carcinoma who have progressed on or were intolerant to standard of care systemic therapy, or for whom standard of care systemic therapy was refused (refusal must be documented) or unavailable. * No prior treatment with anti-PD-1 or anti-PD-L1 therapy. * NSCLC patients whose tumor is not known to have ALK or EGFR mutations must have progressed on or after no more than 1 prior line of platinum-containing systemic therapy or were intolerant or refused standard of care systemic therapy. * NSCLC patients whose tumor is known to have ALK or EGFR mutation must have received prior systemic therapies that only include 1 or more lines of ALK or EGFR targeting drugs and chemotherapy limited to 1 line of a platinum-based regimen and they must have progressed on or after both types of therapies. * Urothelial carcinoma patients must have received up to 2 lines of prior systemic therapy and progressed on or after, experienced disease recurrence within 12 months of neoadjuvant or adjuvant treatment, were intolerant to, ineligible or refused platinum-containing systemic therapy. If urothelial cancer patients are treatment naïve and eligible for platinum-containing systemic therapy but are refusing platinum chemotherapy, they must also be documented to have previous PD-L1 high status. * Provide archived tumor tissue sample taken within the past 2 years or provide a fresh tumor biopsy sample. * At least one measurable lesion as defined by RECIST version 1.1. * Adequate renal, liver, thyroid and bone marrow function. * Performance status 0 or 1. * Patient is capable of receiving study treatment for at least 8 weeks. Exclusion Criteria (Part 2 Only) * Active brain or leptomeningeal metastases. * Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy or prior allogeneic bone marrow or hematopoietic stem cell transplant. * Patients with a condition requiring systemic treatment with either corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * Patients with a history of interstitial lung disease, non-infectious pneumonitis, or active pulmonary tuberculosis. Those with active lung infections requiring treatment are also excluded. * History of Grade >=3 immune mediated AE (including AST/ALT elevations that where considered drug related and cytokine release syndrome) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy. * Active hepatitis B or C, HIV/AIDS. * Other potentially metastatic malignancy within past 5 years.

Study Objectives This ia a single-arm, not-randomized, open-label phase II study. The purpose of this study is to evaluate the safety and efficacy of KN046 (PD-L1 /CTLA-4 Bispecific antibody) combined with Lenvatinib(TKI) for the treatment of advanced hepatocellular carcinoma. Conditions: HCC Intervention / Treatment: BIOLOGICAL: KN046, DRUG: Lenvatinib Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Has a diagnosis of hepatocellular carcinoma confirmed by histology or cytology； * Barcelona Clinic Liver Cancer (BCLC) Stage B or C； * Age >=18 years or <=75 years for both genders； * ECOG performance status: 0-1； * Child Pugh score<=7； * LVEF>=50% or above LLN of the research institution； * Enough organ function； * Has at least one measurable lesion based on RECIST 1.1； * Life expectancy >=3 months； * Patients must be able to understand and willing to sign a written informed consent document； Exclusion Criteria: * Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma etc; * Tumor thrombus invasion at the main portal vein (Vp4), inferior vena cava or heart involvement; * Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.); * Subjects who have received liver local treatment (transcatheter chemoembolization, transcatheter embolization, hepatic artery perfusion, radiotherapy, radioembolization or ablation) within 4 weeks before administration; * Subjects who need corticosteroids or immunosuppressive agents for systemic therapy; * Any previous or current active autoimmune disease or history of autoimmune disease; * History of hepatic encephalopathy or liver transplantation; * History of interstitial lung disease or non-infectious pneumonia; * History of allergic reactions to related drugs; * Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy; * With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable; * Subjects with clinically significant gastrointestinal bleeding or thrombosis or embolic events within 6 months; * Untreated hepatitis infection: HBV DNA>2000IU/ml or10000 copies/ml, HCV RNA> 1000copy/ml, both HbsAg and anti-HCV body are positive; * Evidence of active pulmonary tuberculosis (TB); * Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); * Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage;

Study Objectives Three month treatment of acute VTE with Fragmin in pediatric cancer patients Conditions: Venous Thromboembolism Intervention / Treatment: DRUG: dalteparin Location: Norway, Spain, United States, Slovenia, Russian Federation Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Exclusion Criteria: *

Study Objectives Cannabis sativa is one of the most ancient psychotropic drugs known to humanity. Although most Western countries have outlawed the use of cannabis according to the UN Convention of Psychotropic Substances, an increasing number of states in the USA, Canada and several European countries allow the medicinal use of cannabis subject to a doctor's recommendation. In oncology, the beneficial effects of treatment with the plant or treatment with medicine produced from its components are related to symptoms of the disease: pain, nausea and vomiting, loss of appetite and weight loss. There is only partial clinical evidence of the efficacy of cannabis for these indications. In Israel, according to Ministry of Health regulations, permission to use medicinal cannabis for oncology patients can be given for two indications: to relieve disease-related symptoms in advanced disease or during chemotherapy treatment to reduce side effects. The indications are very wide and allow a great deal of freedom for the physician's decisions, but also cause high demands for cannabis from patients. The cannabis plant and the synthetic drugs based on the plant are considered to be medically safe. Most of the adverse effects are related to the fact that the plant and the drugs are psychoactive. Among the effects named were dizziness, euphoria, difficulty concentrating, disturbances in thinking, memory loss, and loss of coordination. Recently, we published the results of a prospective, observational study evaluating the medical necessity for medicinal cannabis treatment in cancer patients on supportive or palliative care. No significant side effects, except for memory lessening in patients with prolonged cannabis use (p=0.002), were noted. Chemotherapy-related cognitive impairment (CRCI) is a phenomenon of cognitive decline that patients may experience during or after chemotherapy. Memory loss and lack of concentration and attention are the most frequent symptoms encountered. Evidence suggests that CRCI is of significant concern to patients and has become a major quality-of-life issue for survivors, with estimates of its frequency ranging from 14-85% of patients. The influence of cannabis use on cognitive functions of oncology patients has never been tested. Theoretically, the combination of chemotherapy and cannabis can cause severe reduction in cognitive functions in additive or synergistic ways. However, this hypothesis, too, has never been tested, although the number of patients using cannabis during chemotherapy treatments in Israel and in other Western countries is growing. Goals of current research: The main goal of the study is to evaluate prospectively the level of reduction in cognitive function of cancer patients who are on active oncology treatments and use cannabis, comparing to a group of patients without cannabis treatment. The second goal is to identify high-risk groups for cognitive impairment due to cannabis use. Patients and Methods: The study will be comprised of a cannabis user group that will include patients who will come for guidance sessions before being issued with a cannabis license and a control group of patients on active oncology treatments, meeting the same inclusion and exclusion criteria (except for cannabis use), and willing to complete the same pack of questionnaires and cognitive tests at the same three time points. All patients will sign an informed consent form. The study includes questionnaires on quality of life (EORTC-Q30), anxiety, depression (HADS) and fatigue (BFI), and cognitive tests (MoCA, DSST, Digital Finger Tapping) administered by the nurses who give guidance on cannabis according to the patient's language (Hebrew, Russian or Arabic). The nurses will have a short guidance course on "how to do cognitive tests" and a monthly meeting with a neuropsychologist to test the quality of the cognitive tests. The questionnaires and cognitive tests will be done on the day of entering the study (T0) and after 3 (T3) and 6 months (T6). The patients will be asked not to use cannabis in the 12 hours before the interviews after 3 and 6 months. Sample size: The sample size was built to show a difference of 1.1 points in the MoCA test (half the SD for the normal population) between two groups after three months of cannabis use. The number of patients needed with a power of 80%, β≤0.05 and SD=3.1 (the SD for mild cognitive impairment in the MoCA test) is calculated at 42 patients in each group (total 84 patients). Due to an expected drop-out of 20%, the number of patients to be included in the study is 101. Conditions: 1- Cancer Patients During Chemotherapy Treatment, 2- Use of Cannabis Comparing to Control Without Cannabis Use Intervention / Treatment: DRUG: cannabis Location: Israel Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age >18 years * Histological or cytological documentation of malignancy * Chemotherapy treatment * Life expectancy of at least 6 months * Able to sign informed consent. Exclusion Criteria: * Brain tumors or CNS metastasis * Past cannabis use, * Known cognitive diseases such as Alzheimer's disease or other dementias

Study Objectives Chemotharapy plus targeted therapy regimen, as an adjuvant therapy, can effectively reduce the rate of both intrahepatic and extrahepatic recurrence in initially unresectable CRLM patients. Those with KRAS/NRAS/BRAF mutated tumors or cycle of conversion therapy ≤ 4 can benefit more from chemotharapy plus targeted therapyrather than from chemotharapy alone, with a tolerable toxicity profile. Conditions: Colorectal Cancer Metastatic Intervention / Treatment: DRUG: Targeted agent Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Age >= 18 and <= 75 years; * Histologically confirmed CRC; * Initially unresectable synchronous liver metastases (LMs); * Accepted conversion therapy and successfully converted into resectable status; * Underwent R0 intestinal and hepatic resection; * Accepted adjuvant therapy. Exclusion Criteria: * R1/R2 resection; * Extrahepatic metastases; * Accepted postoperative monotherapy; * Lack of follow-up data.

Study Objectives Workplace exposure to secondhand cigarette smoke or environmental tobacco smoke (ETS)is widespread, effecting between 19 and 49% of the U.S. workforce. The first part of this study is designed to test whether exposure to ETS in the workplace effects a person's risk of developing chronic diseases such as cardiovascular disease and cancer. The second part of this study is designed to test whether antioxidant supplementation in this group of ETS exposed individuals can reduce their risk of developing chronic disease. The study will look at 375 non-smokers who either work on a casino floor or as bartenders or cocktail servers. Initial baseline data will be collected (questionnaires and blood samples taken) and the subjects will be randomized into one of three groups, placebo, low antioxidant supplementation and high antioxidant supplementation. They will be followed over a two-year period, coming in for follow-up testing every six months. Statistical analysis will be conducted to see whether this group of ETS exposed individuals has a greater risk of developing chronic disease and whether the use of antioxidant supplements can moderate any risks. Conditions: Cardiovascular Disease, Cancer Intervention / Treatment: DRUG: Antioxidants Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: FACTORIAL Masking: DOUBLE

Inclusion Criteria: Non-smoker Work in a casino - on the casino floor or work as a bartender or cocktail server for at least 1 year Do not take antioxidant supplements Healthy - not diagnosed with any major chronic diseases. Exclusion Criteria: Blood pressure SBP>200,<85 DBP>100, <40 Pulse >120, <45 Cholesterol >400 Triglycerides >700 Blood Cotinine >10 ng/ml BMI >35

Study Objectives The purpose of this study is to test the safety and effectiveness of two investigational drugs (drugs that are not currently approved by the FDA) given in combination with radiation therapy or ablation. Conditions: Metastatic Colorectal Cancer Intervention / Treatment: DRUG: durvalumab, DRUG: tremelimumab, RADIATION: Radiotherapy (RT), PROCEDURE: ablation 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: * Be willing and able to provide written informed consent for the trial. * Histologically- or cytologically- confirmed CRC. * Metastatic CRC. * Subjects have received at least two standard chemotherapy regimens for which they would be considered eligible (at least one containing a 5-fluoropyrimidine), or systemic chemotherapy is not indicated in the setting of low volume metastatic disease. * At least one tumor for which palliative RT is considered appropriate standard therapy (cohort 1); or, at least one tumor for which palliative ablation is considered appropriate standard therapy (cohort 2). * At least one index lesion that will not undergo RT or ablation, and which is measurable based on RECIST 1.1. * Be >= 18 years of age on day of signing informed consent. * Consent for tumor biopsies (for patients enrolled in stage 1 only) and blood draws for research purposes (for all patients). * Consent for use of available archived tissue and tumor obtained during a standard procedure, for research purposes. * Have a performance status of 0 or 1 on the ECOG Performance Scale. * Female subjects must either be of non-reproductive potential (i.e., post-menopausal by history: >=60 years old and no menses for >= 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment. * Demonstrate adequate organ function as defined all screening labs should be performed within 4 weeks prior to treatment initiation. * Hemoglobin >= 8.0 g/dL * Absolute neutrophil count (ANC) >=1,500 /mcL * Platelets >=100,000 / mcL * Serum creatinine <=1.5 X upper limit of normal (ULN) OR * Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) OR * Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance. * Serum total bilirubin <= 1.5 X ULN OR Direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN * AST (SGOT) and ALT (SGPT) <= 2.5 X ULN OR <= 5 X ULN for subjects with liver metastases. aCreatinine clearance should be calculated per institutional standard. Exclusion Criteria: * Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment. * Chemotherapy, monoclonal antibody, targeted small molecule therapy, within 4 weeks prior to dose #1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to a previously administered agent (excluding alopecia or toxicity not anticipated to interfere with planned treatment on study). * Known or suspected MSI-H CRC. * Any prior Grade >=3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1, including anti-PD-1, anti-PD-L1, anti-CD137, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, except for endocrinopathies and asymptomatic amylase/lipase. * If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention per clinical discretion of the investigator prior to starting therapy. * Concurrent active malignancy that requires systemic treatment. * Known CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable without evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. The use of topical steroids is permitted. * Active autoimmune disease requiring systemic immune suppressive treatment within the past 2 years. NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. * Has active, non-infectious pneumonitis. * Active or prior documented inflammatory bowel disease. * History of allogeneic organ transplant. * Has an active infection requiring systemic therapy. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Has known active and untreated Hepatitis B (e.g., HBsAg reactive) or active Hepatitis C (e.g., HCV RNA [qualitative] is detected). * Has received a live vaccine within 30 days prior to the first dose of trial treatment. * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab with the exceptions of premedication and intranasal, topical and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10mg/day of prednisone, or an equivalent corticosteroid. * Hypersensitivity to durvalumab or tremelimumab, or any excipients on the formulation. * Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results. * Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of durvalumab + tremelimumab combination therapy or 90 days after the last dose of durvalumab monotherapy, whichever is the longer time period. * QT interval corrected for heart rate (QTc) >= 470ms calculated from 1 electrocardiogram (ECG) using Fridericia's Correction. * History of primary immunodeficiency. * Known history of previous clinical diagnosis of tuberculosis. * Subjects with uncontrolled seizures.

Study Objectives This protocol is a multicentric interventional phase II study from the French CML Intergroup (FILMC). The core of the protocol is to explore the efficacy and safety of an optimization strategy consisting in the modulation of the dasatinib daily dose according to the results of repeated plasmatic levels of dasatinib. The objective of this strategy is to improve the overall results of the treatment of early CP-CML in order to avoid the development of resistance and BCR-ABL tyrosine kinase mutations. The study will be conducted in selected FILMC and Canadian centers. The study is sponsored by the Hôpitaux de Versailles and supported by Bristol-Myers Squibb. The dasatinib treatment will be provided by Bristol-Myers Squibb until marketing authorization is granted in that indication. Conditions: Chronic Myelogenous Leukemia, BCR/ABL Positive Intervention / Treatment: DRUG: Dasatinib Location: France, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Male or female patient >= 18 years * ECOG Performance Status score 0-2 * Philadelphia chromosome positive newly diagnosed (<= 3 months) CP-CML * patients not previously treated except with hydroxyurea or imatinib (less than 4 weeks for imatinib) * Signed written inform consent * Adequate hepatic function defined as: total bilirubin <= 2.0 times the institutional ULN; ALT and AST <= 2.5 times the institutional upper limit of normal (ULN). * Adequate renal function defined as serum creatinine <= 3 times the institutional ULN. * Women of childbearing potential (WOCBP) must be using an adequate method of contraception. Exclusion Criteria: * Patients with BCR-ABL positive, Philadelphia negative CML * Patient previously treated with a tyrosine kinase inhibitor (TKI) except with imatinib during less than 4 weeks. * Pregnancy * Active malignancy * Uncontrolled or significant cardiovascular disease * Patients with QTc > 450 ms * Significant bleeding disorder unrelated to CML * Concurrent severe diseases which exclude the administration of therapy

Study Objectives This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with recurrent or metastatic head and neck cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Conditions: Recurrent Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx Intervention / Treatment: DRUG: Akt inhibitor MK2206 Location: United States, Singapore, China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed non-keratinizing nasopharyngeal carcinoma that has recurred at locoregional and/or distant sites, and is not amenable to potentially curative radiotherapy or surgery * Measurable disease according to the RECIST criteria * Progressed =< 24 months of receiving one or two prior line(s) of chemotherapy for recurrent disease, of which at least one line must contain platinum drugs such as cisplatin, carboplatin or oxaliplatin * ECOG performance status 0, 1, or 2 * Hemoglobin >= 9 g/dL * ANC >= 1,500/μL * Platelet count >= 100,000/μL * Total bilirubin =< 2.5 times upper limit of normal (ULN) * ALT =< 2.5 times ULN (=< 5 times ULN for patients with liver metastases) * Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 * Ability to understand and the willingness to sign a written informed consent document * Willingness to donate blood for mandatory correlative research studies * Negative (serum) pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Exclusion Criteria: * Any of the following * Chemotherapy =< 4 weeks prior to registration * Radiotherapy =< 4 weeks prior to registration * Nitrosoureas or Mitomycin C =< 4 weeks prior to registration * Those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * NOTE: Prior palliative radiotherapy to bone metastases is allowed =< 4 weeks prior to registration * Prior investigational agents =< 4 weeks prior to registration * Symptomatic brain metastases; NOTE: primary nasopharyngeal cancers that directly invade the skull base and extend into the infratemporal fossa(e) are not regarded as brain metastases and are not excluded * History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or other agents used in the study * Prior potent and moderate inhibitors and inducers of CYP3A4 =< 2 weeks prior to registration: * Drugs that are forbidden, potent inducers of CYP3A4: phenytoin, phenobarbitone, carbamazepine, barbiturate, rifampicin, St John's Wort. * Drugs that significantly affect metabolizing activity by way of enzyme inhibition of CYP3A4: ketoconazole, itraconazole, fluconazole, indinavir, ritonavir, erythromycin, cimetidine, clarithromycin * Unwillingness to go off other inducers and inhibitors of CYP3A4 during the first 2 cycles of MK-2206; NOTE: avoiding these drugs is critical during the first 2 cycles of MK-2206when blood samples are being taken for the correlative study unless there is an urgent medical need and alternatives are not available * Poorly controlled diabetes mellitus or insulin controlled diabetes; NOTE: As a general guide, patients with a fasting glucose level > 150 mg/dL (HbA1c <8%, > 8.3 mmol/L), or a random glucose level of >180mg/dL (> 10 mmol/L) is considered to have inadequately controlled diabetes and are not eligible for this study; however, such patients can become eligible in the future if their fasting glucose levels improve with medical treatment * QTc prolongation (defined as a QTc interval > 450 msec for males and >470 msec for females) or other significant ECG abnormalities; NOTE: patients with clinically significant cardiac conduction abnormalities should be excluded, these include left bundle branch block (LBBB), 2nd or 3rd degree AV block, bifascicular block, sick sinus syndrome, Wolff-Parkinson-white syndrome, sinus bradycardia (< 50bpm); however, patients with asymptomatic right bundle branch block (RBBB) or 1st degree AV block, in the absence of known cardiac disease (e.g. coronary, valvular) are not excluded * Uncontrolled intercurrent illness including, but not limited to: * Ongoing or active infection, * Symptomatic congestive heart failure, * Unstable angina pectoris, * Uncontrolled symptomatic cardiac arrhythmia, * Psychiatric illness/social situations that would limit compliance with study requirements * Diagnosed to have any of the following condition(s), and/or have undergone any one of the following procedure(s) =< 3 months prior to registration: * Symptomatic thrombotic or hemorrhagic cerebral vascular accident * Coronary bypass graft * Angioplasty * Myocardial infarction * Patients having continuing >= grade 2 adverse events (excluding alopecia) due to agents (chemotherapy or radiotherapy) administered > 4 weeks prior to registration based on Common Terminology Criteria for Adverse Events (CTCAE version 4.0) =< grade 1 * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * NOTE: because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MK-2206, breastfeeding should be discontinued if the mother is treated with MK-2206; women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation * HIV-positive patients on combination antiretroviral therapy; NOTE: HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with MK-2206; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy * Recent major surgery =< 4 weeks prior to registration (excluding the placement of vascular access), or minor surgery =< 2 weeks prior to registration * Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption) that impairs patients ability to swallow MK-2206 tablets

Study Objectives This clinical study was planned in order to assess the superiority of INNOCELL Corp. "Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Temozolomide to glioblastoma patients when compared with the control group who did not receive administration of the drug. Conditions: Glioblastoma Intervention / Treatment: DRUG: Activated T lymphocyte(Immuncell-LC) Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients who, prior to the study, received explanation of the purpose and content of study and of characteristics of the test drug from the test administrator and have consented to the study by providing signature of self, guardian, or legal representative. * Patients who are between 18 and 70 years of age * Patients whose cause of cancer has been found to be glioblastoma via pathological testing * patients who have received surgery for glioblastoma (Complete or partial extirpation or biopsy) 2 weeks prior to the study * Patients whose survival is expected to be longer than 3 months * Patients whose KPS is greater than 60 * Patients who satisfy the following conditions of the blood test, kidney function test, and liver function test * Hemoglobin is bigger than 10 gm% * Platelet Count is bigger than 100,000/µL * Absolute granulocyte count is bigger than 1,500/µL * BUN or Creatinine 1.5 x upper normal limit * Bilirubin level is smaller than 2.0 mg/dL * SGOT, SGPT, alkaline phosphatase is smaller than 1.5 x upper normal limit Exclusion Criteria: * Patients who have been determined to have serious Cardio - Pulmonary function disability by the clinical study staff * Patients who are immune deficient or have a history of auto immune diseases (Ex. Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.) * Patients who have a history of malignant tumors in the recent 5 years prior to the study with the exception of skin cancer, local prostate cancer, and cervical cancer. * Patients with history of severe allergies * Patients with serious mental illness * Patients who are pregnant or nursing * Patients who have participated in other clinical tests in the recent 4 weeks prior to the study

Study Objectives Acute myeloid leukemia (AML) is a heterogeneous group of diseases characterized by uncontrolled proliferation of the myeloid line of white blood cells and impaired production of normal blood cells. If untreated, patients die of infection or bleeding usually in a matter of weeks. CSL360 is a neutralising monoclonal antibody which is believed to target the cells that are thought to drive AML but that are not effectively killed by standard treatment. The aims of the study are to determine a biologically active dose of CSL360 and generate understanding of a rational schedule of administration for future studies. Conditions: Acute Myeloid Leukemia (AML) Intervention / Treatment: DRUG: CSL360 Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Clinical diagnosis of acute myeloid leukemia * Recent bone marrow biopsy * Prior treatment or medically unfit for standard therapy Exclusion Criteria: * Peripheral blood blast count > 30 x 109/L, or rapidly progressive AML * Previous solid organ transplant * Active GvHD or immunosuppression * Concurrent treatment with other anti-cancer therapy * Active infections

Study Objectives This trial was to evaluate the efficacy of intratumoral PTS injection in alleviating airway obstruction and dyspnea by improving the percentage of lumen patency of patients with central air way NSCLC tumor severe obstruction. Conditions: Nsclc Intervention / Treatment: DRUG: Para-Toluenesulfonamide Location: China 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 inpatients, aged 18 to 83 years old. * Patients with central air way non-small cell lung cancer (NSCLC) severe obstruction; definition of severe airway obstruction: >=1/2 trachea is obstructed by tumor; and/or block >=2/3 of primary bronchi, right and middle bronchi. And the longest diameter of the lesion > 0.5 cm. * Pathologically confirmed lung cancer. * Patients with tracheal tumor lesions suitable for local intratumoral injection via fibro-bronchoscopy. * At least one measurable lesion that could be evaluated by imaging examination (bronchoscopy, CT, MRI or X-ray etc.) according to the Response Evaluation Criteria in Solid Tumors. * Blood platelet count >= 100,000/mm3. * Subjects who were able to understand and comply with the trial protocol and give written consent. Exclusion Criteria: * Brain metastases. * History of cardiovascular diseases, including congestive heart failure > New York Heart Association (NYHA) Grade II. Patients with unstable angina pectoris (angina pectoris symptoms at rest), recent angina pectoris (occurred in the recent 3 months) or with myocardial infarction in recent 6 months must be excluded. * Severe infections or dysbolism. * Poor hepatic functional reserve or severe hepatocirrhosis, with abnormal blood coagulation indicators. * Poor general conditions or cachexia. * The target lesion had been treated with radiotherapy within 6 months. * Pregnant or breast-feeding woman. * Known hypersensitivity to PTS or related compounds. * Lung cancer lesions not suitable for local treatment. * Any other reason deemed reasonable by the investigator.

Study Objectives The purpose of this trial is to assess the anti-tumour activity and safety of afatinib monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family of receptors) mutations or ERBB2 amplifications (Cohort A), and EGFR (Epidermal Growth Factor Receptor) amplification positive tumours (Cohort B), progressing despite previous platinum based chemotherapy, and thereby to improve their prognosis. The antitumour activity of afatinib monotherapy in these patients will be assessed by progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the trial. A key secondary endpoint will also be defined, the objective response rate (ORR). Conditions: Urologic Neoplasms Intervention / Treatment: DRUG: Afatinib Location: Italy, France, Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria: * Recurrent or metastatic urothelial cancer * Patients must have failed prior platinum based treatment (adjuvant or 1st line) * Archival tissue sample available for biomarker testing at pre-screening and tissue banking. * Patients should complete a pre-screening biomarker analysis and should fulfill the following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should show EGFR (Epidermal Growth Factor Receptor) amplification. * Further inclusion criteria apply Exclusion criteria: * Prior use of EGFR, ERBB2 or ERBB3 targeted treatment * Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first * Known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis * Further exclusion criteria apply

Study Objectives TQB3616 capsule is a small molecule oral drug developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., which inhibits cyclin-dependent kinases 4 and 6 (CDK4/6). Its main mechanism of action is to inhibit the proliferation of tumor cells by reducing the phosphorylation level of retinoblastoma protein (Rb) in cancer cells and blocking the progression of cells from G1 phase to S phase. This study is a randomized, open-label, single-center, two-period, two-crossover phase I clinical trial to assess the effect of food on the pharmacokinetics of TQB3616 capsules in healthy adult subjects, to evaluate the effect of food on the pharmacokinetics of TQB3616 capsules after oral administration in healthy adult Chinese subjects and to observe the safety of TQB3616 capsules after single oral administration in healthy subjects.Each subject will be randomly assigned to one of two groups (group A and B). A total of 16 subjects were enrolled, all taking TQB3616 capsules 180mg, including 8 subjects in group A and 8 subjects in group B. The study included screening period, randomization, first cycle, washout period and second cycle. The first cycle and second cycle each contained 3 return visits. 18 pharmacokinetic samples were collected every cycle for pharmacokinetic index analysis. Vital signs, physical examinations, 12-lead electrocardiograms, clinical laboratory tests, adverse events, drug combination and non-drug therapy information were collected during the study to ensure the safety of the subjects. Conditions: Recurrent/Metastatic Breast Cancer Intervention / Treatment: DRUG: TQB3616 Capsule Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * 1 Sign the informed consent form before the trial and fully understand the content, process and possible adverse reactions of the trial; * 2 Be able to complete the study according to the requirements of the study protocol; * 3 Subjects aged 18 to 65 years (including 18 and 65 years); * 4 Body mass index (BMI) >= 18 and <= 28 kg/m2, and male body weight >= 50 kg Female body weight >= 45 kg; * 5 Health condition: no mental disorders, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities; * 6 Subjets had no plans to become pregnant and voluntarily took effective contraceptive measures from 2 weeks before dosing to at least 6 months after the last dose of study drug. Exclusion Criteria: * 1 Patients with a history of neuropsychiatric, respiratory, cardiovascular, gastrointestinal, hemolymphatic, hepatic or renal insufficiency, endocrine, musculoskeletal system disease or other diseases, which may affect drug metabolism or safety as judged by the investigator; * 2 Allergic constitution or previous history of two or more kinds of food or drug allergy; * 3 Hyperactive/venous thrombotic events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism; * 4 Patients with multiple factors affecting oral drugs (such as inability to swallow, gastrointestinal diseases); * 5 Taking any prescription drugs, over-the-counter drugs, vitamin products or herbal medicines within 1 month before taking the study drug; * 6 Administration of CYP3A4 inhibitors or inducers within 1 month before screening or before study drug; * 7 Taking special diet (including grapefruit, etc.) or strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 14 days before screening; * 8 Abnormal and clinically significant laboratory findings during the screening period; * 9 Blood donation or significant blood loss (> 450 mL) within 3 months prior to administration of study drug; * 10 Participated in any drug clinical trial within 3 months before taking the study drug; * 11 Smoking more than 5 cigarettes per day within 3 months before the trial; * 12 Positive breath alcohol test or history of alcoholism (14 units of alcohol per week: 1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol or 150 mL of wine); * 13 Drug screening positive or drug use 3 months before the trial; * 14 Inability to tolerate venipuncture for blood sampling or poor vascular status; * 15 Subjets cannot complete the trial due to personal reasons; * 16 Other conditions considered inappropriate by the investigator.

Study Objectives The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC). Conditions: Prostate Cancer Intervention / Treatment: DRUG: CTT1403, DRUG: CTT1057, DRUG: 68Ga-PSMA-11 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Patients must have histologically confirmed prostate adenocarcinoma that is metastatic and castration resistant (mCRPC). * At least 3 metastatic foci avid for PSMA-specific PET agent (CTT1057) uptake on Screening PSMA PET. * Has received docetaxol, ineligible for docetaxol, or refused docetaxol for the treatment of prostate cancer. * Has progression by the PCWG3 criteria during or after treatment with either abiraterone or enzalutamide * Male Age >= 18 years. * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2). * Demonstrate adequate organ function Exclusion Criteria: * Has received previous treatment with radium-223 or another radiopharmaceutical within 3 months prior to first dose of CTT1403. * Has received prior systemic anti-cancer therapy (excluding radiopharmaceutical) within 14 days, or 5 half-lives, whichever is shorter, prior to first dose of CTT1403. * Has received external-beam radiation within 14 days prior to first dose of CTT1403. * Has received cabazitaxel for the treatment of mCRPC. * Has received previous treatment with a therapeutic targeting PSMA. * Has an additional active malignancy requiring therapy that may confound the assessment of the study endpoints. * Has clinically significant cardiovascular disease * Has a history of untreated brain metastases * Has evidence of diffuse bone marrow involvement by prostate cancer in the judgment of study investigator. * Clinically significant urinary obstruction or moderate/severe hydronephrosis on baseline imaging. * Has a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before CTT1403 administration. * Has known positive status for chronic hepatitis B or hepatitis C * Known or suspected myelodysplastic syndrome. * Has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.

Study Objectives The purpose of this study is to test the effect of the combination of sunitinib and bortezomib. We will see what effects it has on your cancer and find the highest dose of each agent that can be given without causing severe side effects. Conditions: Solid Tumors Intervention / Treatment: DRUG: Sunitinib and Bortezomib 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: Each patient must meet all of the following inclusion criteria to be enrolled in the study: * Refractory advanced solid tumor that has failed standard therapy. * ECOG PS <= 2 * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. * Male subject agrees to use an acceptable method for contraception for the duration of the study. * Cardiac ejection fraction is more than 45% Exclusion Criteria: * Patient has a platelet count of <100 x 109/L within 14 days before enrollment. * Patient has an absolute neutrophil count of ANC <1.0 x 109/L within 14 days before enrollment. * Patient has a calculated or measured creatinine clearance of <30 mL/minute within 14 days before enrollment. * AST, ALT, total bilirubin > twice the upper limits of normal. * Received radiation to more than 30% of marrow volume * Patient has greater than or equal to Grade 2 peripheral neuropathy within 14 days before enrollment. * Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant. * Patient has hypersensitivity to sunitinib, bortezomib, boron or mannitol. * Uncontrolled hypertension * History of venous thromboembolic events. * Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum Beta-human chorionic gonadotropin (Beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. * Patient has received other investigational drugs with 14 days before enrollment * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Hemorrhagic tendency of the tumor

Study Objectives The purpose of this study is to see if Cediranib in combination with FOLFOX is effective in treating metastatic colorectal cancer and to see how it compares with Avastin (Bevacizumab) in combination with FOLFOX. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: Cediranib, DRUG: Bevacizumab, DRUG: 5-fluorouracil ( in FOLFOX), DRUG: Leucovorin (in FOLFOX), DRUG: Oxaliplatin (in FOLFOX) Location: Hungary, Canada, Turkey, Egypt, United States, Taiwan, Austria, Philippines, France, Poland, Vietnam, Israel, India, Thailand, Italy, Ukraine, United Kingdom, South Africa, Russian Federation, Finland, Spain, Belgium, Latvia, Germany, Czech Republic, Malta, Australia, Slovakia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Clinical Diagnosis of colon or rectal cancer * No prior systemic therapy for metastatic disease. Any adjuvant/neoadjuvant oxaliplatin therapy must have been received >12 months prior to study entry and adjuvant/neoadjuvant 5-FU must have been received >6 months prior to study entry. Exclusion Criteria: * Prior treatment with a VEGF Inhibitor, including bevacizumab and cediranib. * Poorly controlled hypertension

Study Objectives This is a phase II study of the combination of oxaliplatin and trastuzumab as first or second line therapy in patients with stage IV, metastatic breast cancer Conditions: Breast Cancer Intervention / Treatment: DRUG: Trastuzumab, DRUG: Oxaliplatin 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: * Females >= 18 years of age * Histologically confirmed breast cancer that is HER2/neu positive (3+ by IHC or FISH +) and evidence of metastatic disease. Tumor may be of any estrogen and progesterone receptor type * Measurable disease by RECIST and an ECOG <= 2 * Patients with known evidence of brain metastases are eligible if they are asymptomatic and have completed all therapy (surgery, radiotherapy, and/or steroids) * Baseline LVEF value within the institutional normal range * Any number of prior hormonal therapy treatments in the adjuvant setting or for metastatic disease. A subject must have progressed on hormonal therapy and all hormonal therapy (including birth control pills) must be discontinued at study entry. * Prior chemotherapy in the adjuvant setting and up to one prior chemotherapy regimen for metastatic disease is allowed. * Patients may have received one prior trastuzumab/chemotherapy containing regimen or prior single agent trastuzumab. * Prior radiation therapy in the adjuvant setting or for metastatic disease, provided it was not to the only site of evaluable disease. * All prior chemotherapy, trastuzumab and radiation therapy should be completed > 2 weeks before enrollment. * Patients receiving bisphosphonate therapy are eligible. However, if bisphosphonate were started within < 2 months prior to enrollment, the bone lesions will not be evaluated for response and the patient must have another site of metastatic disease that is either measurable or evaluable for response. * Patients must have recovered from toxicities due to prior therapy. * Lab values in accordance with the protocol * Patients must be nonpregnant and nonlactating. Patients of childbearing potential must implement an effective method of contraception during the study (birth control pills are not allowed). Exclusion Criteria: * Bone only disease are ineligible * Patients who received more than 1 prior chemotherapy regimen for metastatic disease are ineligible. * Patients with a history of other cancers except curatively-treated carcinoma of the cervix in situ or non-melanomatous skin cancer. * Active serious infection or other underlying medical condition that would impair their ability to receive protocol treatment. * Uncontrolled nervous system metastases * Dementia or significantly altered mental status that would interfere with proper consenting. * Receiving other investigational therapy.

Study Objectives Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years. Conditions: Breast Cancer Intervention / Treatment: DRUG: Zoledronic acid, DRUG: Letrozole Location: Korea, Republic of, Italy, Netherlands, Spain, Belgium, Saudi Arabia, Argentina, South Africa, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Stage I-IIIa breast cancer * Postmenopausal * Recent surgery for breast cancer Exclusion Criteria: * Metastatic disease * Invasive bilateral disease * Clinical or radiological evidence of existing fracture in spine or hip Other protocol-defined inclusion / exclusion criteria may apply.

Study Objectives The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available. Conditions: Advanced Solid Tumors, Recurrent Solid Tumors Intervention / Treatment: DRUG: ONO-4538 Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * The treatment phase has been completed in the ONO-4538-13 study Exclusion Criteria: * The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic image is performed in the treatment phase of ONO-4538-13 study. * It is determined that continuing the treatment is not appropriate because the worsening of clinical symptoms attributed to disease progression occurs.

Study Objectives A randomized controlled trial (RCT), 60 HNC patients who underwent radiotherapy (RT) with or without chemotherapy represented the sample of the study. They were assigned randomly into two equal groups, control group (CG) and study group (SG). Routine methods of nursing were given during radiotherapy including health education, skin self-care, and skin protective agent for both groups CG and SG. The patients in study group treated with photon therapy (3x/week) for 6 weeks with a total of 18 sessions. The severity of skin reactions was assessed by the criteria of the Radiation Therapy Oncology Group (RTOG) and dermoscopy for both groups were recorded. Conditions: Head and Neck Cancers - Nasopharyngeal Intervention / Treatment: DEVICE: photon therapy face mask Location: Egypt Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * All patients were free from any skin diseases, All patients enrolled to this study signed their informed consent,All the patients who had Nasopharyngeal tumor receiving radiotherapy who participated in this study, diagnosed by an oncologist and confirmed by MRI, C.T and laboratory investigations). Exclusion Criteria: * patients with communication disorders, patients who were unwilling to take part in this treatment, patients with tumor recurrence, patients with tumor stage 3 or more and patients with skin diseases

Study Objectives To determine the effect of increasing serum 25(OH)D from prevailing levels with vitamin D3 supplementation, while maintaining adequate calcium intake, on incidence of all-type cancer in a population sample of healthy postmenopausal women. Conditions: Cancer Intervention / Treatment: DIETARY_SUPPLEMENT: Vitamin D3, DIETARY_SUPPLEMENT: Calcium carbonate Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Age: >= 55 years * Last menstrual period (LMP): >= 4 years * Good general health * Willingness to participate in this 4 year long study * Able to give informed consent * Able to live independently and travel to the Fremont Area Medical Center (FAMC) for study visits Exclusion Criteria: * History of cancer except * Superficial basal or squamous cell carcinoma of the skin * Other malignancies treated curatively more than 10 years ago * History of renal calculi or chronic kidney disease * History of sarcoidosis * History of tuberculosis * Participation in the previous Creighton cancer prevention study * Mini-Mental Status Exam (MMSE) score of <= 23. Use the MMSE if there are any concerns about the person's cognitive abilities or ability to give fully informed consent to the study. Concerns may be related to a person's lack of orientation to person, place, or time; language difficulties (inability to structure simple, complete sentences); or short term memory. The Hartford Institute for Geriatric Nursing recommends that a score of 23 or lower indicates cognitive impairment. (Accessed at www.harforddign.org). See appendix.

Study Objectives This study will investigate the drug-drug interactions (DDIs) between rucaparib and oral rosuvastatin (Arm A), and between rucaparib and oral ethinylestradiol and levonorgestrel (Arm B), with rucaparib as a perpetrator. Conditions: Neoplasms Intervention / Treatment: DRUG: Rucaparib, DRUG: Rosuvastatin, DRUG: Oral Contraceptives Location: Hungary, Slovakia, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria (All patients): * Willing to sign the ICF and to comply with the study restrictions * Body mass index (BMI) 18.0 to 35.0 kg/m2 * Histologically or cytologically confirmed advanced solid tumor * Patients who, in the opinion of the Investigator, could potentially benefit from treatment with rucaparib * ECOG performance status less than or equal to 1 * Adequate organ function Inclusion Criteria (Arm A): * Male or female patients >= 18 years of age Inclusion Criteria (Arm B): * Female patients >= 18 years of age Exclusion Criteria (All patients): * Specific cancer treatments within 14 days prior to Day 1 * Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, acute coronary syndrome, cardiac angioplasty, stenting, or poorly controlled hypertension within the last 3 months prior to screening * Pre-existing duodenal stent, recent or existing bowel obstruction * Untreated or symptomatic central nervous system (CNS) metastases. Patients with treated asymptomatic CNS metastases are eligible * Known HIV or AIDS-related illness, acute or history of chronic hepatitis B or C * Female patients who are pregnant or breastfeeding * Participation in another investigational drug trial within 30 days prior to Day 1 or exposure to more than 3 new investigational agents within 12 months prior to Day 1 * Presence of active infection requiring antibiotics * Active second malignancy * History of drug abuse (including alcohol) Exclusion Criteria (Arm A): * Current use of rosuvastatin or any other statin * History of hypersensitivity to rosuvastatin * Current, or history of, clinically significant myopathy Exclusion Criteria (Arm B): * Current use of any 1 of the contraceptive drugs or previous contraceptive implants or depot injections, which may still be clinically effective * History of hypersensitivity to ethinylestradiol or levonorgestrel

Study Objectives Adherence (or compliance with) a medication regimen is generally defined as the extent to which patients take medication as prescribed by their health care providers. The adherence to medications has close relation to effectiveness of the therapy. The primary objective of this study is to observe the adherence to treatment with oral clodronate (PDC, proportion of days covered, number of days in which clodronate is taken according to treating physician recommendation) in patients with malignancy. The secondary "hypothesis generating" objective is to describe the relation between adherence to treatment with oral clodronate and efficacy of the therapy (skeletal events, pain). Conditions: Breast Neoplasms, Prostatic Neoplasms, Multiple Myeloma, Osteolysis Intervention / Treatment: DRUG: Clodronate (Bonefos, BAY94-8393) Location: Czech Republic Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Diagnosis of breast cancer, prostate cancer, multiple myeloma and other skeletal events causing tumors * Bone metastases * Therapy with clodronate (1600 mg per day, 800 mg tablets) according to SmPC (Summary of Product Characteristics) Bonefos. * By agreeing to usage of patients diaries and goodwill with accounting of tablets Exclusion Criteria: * According to SmPC (Summary of Product Characteristics) Bonefos.

Study Objectives The goal of this clinical research study is to learn how dasatinib affects biomarker levels in patients with malignant pleural mesothelioma that may be able to be removed by surgery. The safety and effectiveness of this drug will also be studied. This research study is financially supported by the United States Department of Defense. Conditions: Malignant Pleural Mesothelioma Intervention / Treatment: DRUG: Dasatinib 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 with potentially resectable malignant pleural mesothelioma, IMIG stage I-III * Subject, age >= 18 years * Any patient who is able to tolerate general anesthesia for the extended surgical staging and the definitive surgical resection. * No prior chemotherapy for mesothelioma within the last 3 years * No prior radiation to the area of primary disease. Radiation to chest wall port sites is acceptable. * No prior targeted biologic therapy (i.e. EGFR inhibitors, VEGF inhibitors) within the last 3 years * Adequate Organ Function: a) Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN), b) Hepatic enzymes (AST, ALT ) <= 2.5 times the institutional ULN, c) Serum Na, K+, Mg2+, Phosphate and Ca2+>= Lower Limit of Normal (LLN), d) Serum Creatinine < 1.5 time the institutional ULN, e) Hemoglobin, Neutrophil count, Platelets, PT, PTT all Grade 0-1 * Ability to take oral medication (dasatinib must be swallowed whole) * Women of childbearing potential (WOCBP) must have: A negative serum or urine pregnancy test (sensitivity <= 25IU HCG/L) within 72 hours prior to the start of study drug administration * Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped * Signed written informed consent including HIPAA according to institutional guidelines Exclusion Criteria: * Malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 3 years. * Prior therapies to be excluded: any prior chemotherapy or targeted biologic therapy for mesothelioma used within the last 3 years * Concurrent medical condition which may increase the risk of toxicity, including: a) Clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand's disease) b) Any disease which requires persistent anticoagulation therapy (and the patient may not be taken off the anti-coagulation safely) with coumadin, factor Xa inhibitors, or heparin (low-molecular weight, standard) * Cardiac Symptoms, consider the following: a) Uncontrolled angina, congestive heart failure or MI within (6 months), b) Diagnosed congenital long QT syndrome: 1. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes), 2. Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec), 3. Subjects with hypokalemia or hypomagnesemia if it cannot be corrected * History of significant bleeding disorder unrelated to cancer, including: a) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease), b) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies), c) Ongoing or recent (<= 3 months) significant gastrointestinal bleeding * Concomitant Medications, consider the following prohibitions: a) Drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib): A) quinidine, procainamide, disopyramide, B) amiodarone, sotalol, ibutilide, dofetilide, C) erythromycin, clarithromycin, D) chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide E) cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine. F) moxifloxacin, levofloxacin * The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is not recommended.The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy.a)Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy,b)Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia,c)Patient may not be receiving any prohibited CYP3A4 inhibitors,d)Patient may not be receiving any alternative herbal remedies during the dasatinib treatment period * Women: a) are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or, b) have a positive pregnancy test at baseline, or c) are pregnant or breastfeeding, d) Sexually active women of childbearing potential (WOCBP) must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized., * -continued from exclusion #8-: e) Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy., f) All WOCBP MUST have a negative pregnancy test prior to first receiving dasatinib. If the pregnancy test is positive, the patient must not receive dasatinib and must not be enrolled in the study. * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness

Study Objectives The purpose of this study is to determine the maximum tolerated dose of Genexol®-PM plus Carboplatin and evaluate the efficacy and safety of Genexol®-PM plus Carboplatin regimen in subjects with advanced ovarian cancer. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: Genexol-PM 220mg/㎡, Carboplatin 5AUC, DRUG: Genexol-PM 260mg/㎡, Carboplatin 5AUC, DRUG: Genexol-PM 300mg/㎡, Carboplatin 5AUC Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Women >= 18 years old. * Signed informed consent before inclusion. * Subjects who have histologically or cytologically confirmed advanced epithelial ovarian cancer.(FIGO IIIB-IV) * Subjects who have measurable disease by RECIST after debulking surgery. * ECOG performance status of 0, 1, or 2. * Estimated life expectancy of more than 6 months * Subjects who have the clinically acceptable function of blood, kidney and liver at screening visit * Hb >= 10g/dl * ANC >= 1.5×10^9/L * Platelet Count >= 100×10^9/L * Serum total bilirubin <= 1.5×ULN * Serum AST and ALT <= 2.5×ULN * Serum ALP <= 2.5×ULN * Serum creatinine <= 1.5×ULN Exclusion Criteria: * Subjects who have received chemotherapy for ovarian cancer other than debulking surgery. * Subjects who have a history of radiotherapy to pelvis or abdominal cavity * Subjects who receive immunotherapy or hormonal therapy for ovarian cancer * Subjects who have other malignancies within the past 5 years * Subjects who have had a major surgery other than debulking surgery within 2 weeks prior to the screening/baseline visit * Subjects who have a history of metastasis or currently have a metastasis to the central nervous system(CNS) * Subjects who have a preexisting sensory or motor neuropathy of grade >= 1 based on NCI CTCAE V3.0 * Subjects who have serious medical condition * Uncontrolled or severe cardiovascular disease(Ischemic heart disease, myocardial infarction within the last 6 months, congestive heart failure) * Uncontrollable infection * Previous allergic reactions in connection with paclitaxel and carboplatin * Subjects who participate another clinical trial within the last 4 weeks before inclusion

Study Objectives The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab. Conditions: Colon Cancer, Rectal Cancer Intervention / Treatment: BIOLOGICAL: Ramucirumab, BIOLOGICAL: Icrucumab, DRUG: mFOLFOX-6 Location: United States, Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI or CAPIRI [capecitabine + irinotecan], with or without bevacizumab) * Age >= 18 years * Life expectancy of >= 6 months * Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry * Agrees to adequate contraception during the study period and for 12 weeks after the last dose of study medication * Provided signed informed consent Exclusion Criteria: * Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the last dose of oxaliplatin was administered > 12 months prior to randomization) * Has documented and/or symptomatic brain or leptomeningeal metastases * Has an ongoing or active infection, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders * On chronic non-topical corticosteroid treatment. A participant discontinuing such treatment > 3 months prior to randomization is eligible * Has uncontrolled or poorly controlled hypertension on a standard regimen of antihypertensive therapy * Has a concurrent active malignancy. A participant with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years * If female, is pregnant (confirmed by serum beta human chorionic gonadotropin [βHCG] test) or lactating * Has received a prior autologous or allogeneic organ or tissue transplantation * Has undergone major surgery within 28 days prior to randomization * Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization * Has an elective or planned major surgery to be performed during the course of the trial * Has a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention in the 12 months prior to randomization

Study Objectives This is an open label, multi-center, Phase 1/2 study of BBI608 administered in combination with immunotherapy in adult patients with advanced cancers. The goal of the study is to determine the RP2D of BBI608 in combination with each of the immunotherapeutic agents. Conditions: Cancer Intervention / Treatment: DRUG: BBI608, DRUG: Ipilimumab, DRUG: Nivolumab, DRUG: Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria: * Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements * A histologically or cytologically confirmed cancer that is metastatic, unresectable, or recurrent and for which treatment with ipilimumab, or nivolumab, or pembrolizumab is a reasonable therapeutic option in the opinion of the investigator. * >= 18 years of age * Measurable disease as defined by Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last dose * Females of childbearing potential must have a negative serum pregnancy test * Aspartate transaminase (AST) < 2.5 x upper limit of normal (ULN) and alanine transaminase (ALT) <= 2.5 × upper limit of normal (ULN). * Hemoglobin (Hgb) >= 9 g/dl * Total bilirubin <= 1.5 × ULN. Patients with liver lesions who do not have hepatocellular carcinoma and who have a total bilirubin < 2.0 x ULN may be eligible if agreed upon by the investigator and medical monitor for the sponsor. * Creatinine <= 1.5 × ULN or, for patients with creatinine levels above institutional upper limit of normal, creatinine clearance must be > 60 mL/min/1.73 m^2. * Absolute neutrophil count >= 1.5 x 10^9/L * Platelets >= 100 x 10^9/L; patients with hepatocellular carcinoma may enroll provided they have a platelet count >= 75 x 10^9/L. * Life expectancy >= 3 months Exclusion criteria: * Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose of BBI608. Patients may begin BBI608 on a date determined by the investigator and medical monitor for the sponsor after a minimum of 7 days since last receiving anti-cancer treatment, provided that all treatment-related adverse events (AEs) have resolved or have been deemed irreversible * Had a surgical procedure requiring general anesthesia or inpatient hospitalization for recovery less than 4 weeks prior to beginning protocol therapy. * Any known, untreated, brain metastases. Treated subjects must be stable 4 weeks after completion of treatment for brain metastases and image documented stability is required. Patients must have no clinical symptoms from brain metastases and have not required systemic corticosteroids >10 mg/day prednisone or equivalent for at least 2 weeks prior to first dose of study drug. * Pregnant or breastfeeding * Unable or unwilling to swallow BBI608 capsules daily * Significant gastrointestinal disorder(s) (e.g., active Crohn's disease or ulcerative colitis, or a history of extensive gastric resection and/or small intestinal resection) such that absorption of oral medications is impaired. * Has an active autoimmune disease requiring immunosuppression with the exception of subjects with isolated vitiligo, resolved childhood asthma or atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and euthyroid patients with a history of Grave's disease. * Has interstitial lung disease or active, non-infectious pneumonitis * Has a transplanted organ or has undergone allogeneic bone marrow transplant * Has received a live vaccine within 30 days prior to first dose. * Known hypersensitivity to a component of protocol therapy * Uncontrolled concurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or on mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements * Subjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; c) localized prostate cancer not requiring systemic therapy; and c) other primary tumors with no known active disease present that, in the opinion of the investigator and medical monitor for the sponsor, will not affect patient outcome in the setting of the current diagnosis. * Abnormal ECGs that are clinically significant such as QT prolongation (QTc > 480 msec), clinically significant cardiac enlargement or hypertrophy, new bundle branch block or existing left bundle branch block, or signs of new, active ischemia.

Study Objectives This phase II trial studies how well pembrolizumab and lenvatinib work in treating patients with differentiated thyroid cancer that has spread to other places in the body or has come back and cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Conditions: Columnar Cell Variant Thyroid Gland Papillary Carcinoma, Follicular Variant Thyroid Gland Papillary Carcinoma, Metastatic Thyroid Gland Follicular Carcinoma, Metastatic Thyroid Gland Papillary Carcinoma, Poorly Differentiated Thyroid Gland Carcinoma, Recurrent Differentiated Thyroid Gland Carcinoma, Recurrent Thyroid Gland Follicular Carcinoma, Recurrent Thyroid Gland Papillary Carcinoma, Stage III Differentiated Thyroid Gland Carcinoma AJCC v7, Stage III Thyroid Gland Follicular Carcinoma AJCC v7, Stage III Thyroid Gland Papillary Carcinoma AJCC v7, Stage IV Thyroid Gland Follicular Carcinoma AJCC v7, Stage IV Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7, Stage IVC Differentiated Thyroid Gland Carcinoma AJCC v7, Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7, Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7, Tall Cell Variant Thyroid Gland Papillary Carcinoma, Thyroid Gland Hurthle Cell Carcinoma, Unresectable Differentiated Thyroid Gland Carcinoma, Unresectable Thyroid Gland Carcinoma Intervention / Treatment: OTHER: Laboratory Biomarker Analysis, DRUG: Lenvatinib, DRUG: Lenvatinib Mesylate, BIOLOGICAL: Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Locally recurrent and unresectable and/or distant metastatic differentiated thyroid cancer (DTC), histologically or cytologically confirmed; the diagnosis of DTC includes the following subtypes: papillary thyroid cancer (PTC) (including but not limited to variants such as follicular variant, tall cell, columnar cell, Hurthle cell variant of papillary carcinoma, and poorly differentiated), follicular thyroid cancer (FTC), including insular variant, Hurthle cell carcinoma and poorly differentiated thyroid cancer * Measurable disease meeting the following criteria: * At least 1 lesion of >= 1.0 cm in the longest diameter for a non-lymph node or >= 1.5 cm in the short-axis diameter for a lymph node which is serially measurable according to RECIST 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI); if there is only one target lesion and it is a non-lymph node, it should have a longest diameter of >= 1.5 cm * Lesions that have had external beam radiotherapy (EBRT) or loco-regional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion * For cohort 1 only: evidence of disease progression =< 14 months prior to registration according to RECIST 1.1, as confirmed by the site study principal investigator (PI) * For cohort 2 only: progressive disease (PD) on lenvatinib per RECIST 1.1 =< 60 days prior to registration, as confirmed by the site study PI; patients need to have documented imaging and measurement of RECIST target lesions within 30 days of starting pembrolizumab * Radioiodine (RAI)-resistant disease as defined by one or more of the following criteria: * One or more measurable lesions that do not demonstrate RAI uptake * One or more measurable lesions progressive by RECIST 1.1 =< 14 months of prior RAI therapy * One or more measurable lesions present after cumulative RAI dose of >= 600 mCi * One or more measurable lesions that are fludeoxyglucose F-18 (FDG)-avid (> 5 standardized uptake value [SUV]), if positron emission tomography (PET)/CT scan performed; these lesions may also be RAI-avid * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Absolute neutrophil count (ANC) >= 1,500 /mcL (obtained =< 30 days prior to registration) * Platelets >= 100,000 / mcL (obtained =< 30 days prior to registration) * Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin dependency (=< 7 days prior to registration) (obtained =< 30 days prior to registration) * Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (obtained =< 30 days prior to registration) * Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN (obtained =< 30 days prior to registration) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN OR =< 5 X ULN for subjects with liver metastases (obtained =< 30 days prior to registration) * Albumin >= 2.5 mg/dL (obtained =< 30 days prior to registration) * International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X 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 (obtained =< 30 days prior to registration) * Activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (obtained =< 30 days prior to registration) * Adequately controlled blood pressure with or without antihypertensive medications defined as blood pressure (BP) < 150/90 mmHg at screening * Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only * Ability to complete patient medication and blood pressure diaries by themselves or with assistance * Willing and able to provide informed written consent * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Note: during the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up * Willing to provide tissue and blood samples for correlative research purposes Exclusion Criteria: * Cohort 1 only: prior treatment with previous VEGFR active multikinase inhibitor * Cohort 2 only: discontinued lenvatinib due to toxicity * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment * Female subjects of childbearing potential: unwilling or unable to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; NOTE: subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year * Male subjects: unwilling or unable to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive (HIV 1/2 antibodies) and currently receiving antiretroviral therapy * Currently participating and receiving study therapy (except lenvatinib for patients in cohort 2) or has participated in a study of an investigational agent and received study therapy within 4 weeks prior to registration * Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy =< 7 days prior to the first dose of trial treatment * Known history of active TB (Bacillus tuberculosis) * Hypersensitivity to pembrolizumab or any of its excipients * Prior anti-cancer monoclonal antibody (mAb) =< 4 weeks prior to registration or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered >= 4 weeks prior to registration * Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 (except lenvatinib for patients in cohort 2) or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent * NOTE: * Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study * If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to registration, as deemed by treating investigator or site PI * Known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis; NOTE: subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for >= 7 days prior to trial treatment; this exception does not include carcinomatous meningitis which is excluded regardless of clinical stability * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); NOTE: replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment * Known history of, or any evidence of active, non-infectious pneumonitis that required steroids * Active infection requiring systemic therapy * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent * Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) * Received a live vaccine =< 30 days of planned start of study therapy; NOTE: seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed * Proteinuria > 1+ on dipstick urinalysis; patients with > 1+ proteinuria on dipstick urinalysis will undergo 24-hour urine collection for quantitative assessment; NOTE: patients with > 1 g/24 hours will be ineligible * Clinically significant gastrointestinal malabsorption syndrome * New York Heart Association congestive heart failure of grade II or above, unstable angina, myocardial infarction within the past 6 months, or serious cardiac arrhythmia associated with significant cardiovascular impairment within the past 6 months; ejection fraction (EF) by multi-gated acquisition (MUGA) or echo should not be less than the institutional lower limit of normal * Corrected QT (QTc) prolongation > 480 msec, as calculated by either the Bazett or Fridericia formula, as per institutional standard * Active hemoptysis (bright red blood > 1 teaspoon on more than one occasion) =< 3 weeks prior to registration * Cohort 2 only: more than one prior treatment with VEGFR active multikinase inhibitor prior to original start of lenvatinib

Study Objectives Fentanyl is expected to suppress tracheal tube-induced cough during emergence from general anaesthesia through binding to its receptors in the brainstem. However, it has not been proven if fentanyl has a complication-free, dose-dependent effect on cough suppression during emergence from sevoflurane anaesthesia. The purpose of this study is to evaluate the relationship between fentanyl doses and cough suppression during emergence from sevoflurane anaesthesia. Conditions: Thyroid Neoplasm Intervention / Treatment: DRUG: fentanyl citrate, DRUG: saline Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * the patients undergoing general anaesthesia for elective thyroidectomy due to thyroid neoplasm. * ASA I-II. * 20-59 years old. * female only. Exclusion Criteria: * signs of difficult intubation. * risks for perioperative pulmonary aspiration. * history of chronic respiratory disease. * recent upper respiratory track infection. * previous and recent smoking history

Study Objectives This study is a pilot study to evaluate high-dose conformal radiation therapy (HDCRT) administered in combination with pembrolizumab in patients with solid tumors. Conditions: Solid Tumor Intervention / Treatment: RADIATION: High-Dose Conformal Radiation Therapy, DRUG: Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subjects must have a histologically or cytologically proven advanced solid tumor malignancy for which palliative radiation is recommended. In solid tumors where pembrolizumab has been approved for use, patients may receive pembrolizumab as indicated, in the context of this protocol. In solid tumors where pembrolizumab has not been approved for use, the following criteria apply: * Patients must be resistant to at least 1 prior conventional chemotherapy regimen or other standard of care regimen, * Patient must have no remaining conventional treatment options proven to provide long-term disease control, and * Patient has declined other conventional treatment options * Palliative radiation therapy may be recommended for primary tumor and/or any metastatic site that is accessible to biopsy. * At least one site of disease that is accessible to radiation and multiple biopsies. Subjects may have disease that is encompassed within the radiation field or may have known disease both inside and outside of the radiation field. * Must be able to provide tissue from 2-3 separate biopsy procedures that will be completed throughout the course of the study. * A performance status of 0, 1 or 2 on the ECOG Performance Scale. * Subjects must demonstrate adequate organ function. * A life expectancy >= 6 months. Exclusion Criteria: * Requires urgent treatment with cytotoxic chemotherapy or other therapy is indicated. * A diagnosis of immunodeficiency. * A known history of active TB (Bacillus Tuberculosis). * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with untreated brain metastases and patients who have had brain metastases re-treated with radiation will be excluded. Patients whom have either midline shift, or any signs of herniation (even if disease has been treated with GK) will be excluded. Subjects with previously treated brain metastases may participate provided they are 1) stable (without clinical evidence of progression) 2) are out at least 10 days from CNS radiation and 3) and are not using steroids as part of treatment for their brain lesions for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. * Active autoimmune disease that has required systemic treatment in the past 2 years. * A history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * An infection requiring systemic therapy. * Pregnancy. * HIV positivity. * Evidence of active Hepatitis B virus or Hepatitis C virus. * Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, uncontrolled arrhythmias, or severe valvular heart disease, or a myocardial infarction within 6 months prior to the first dose of study treatment. * Active bleeding disorders or evidence of chronic or acute disseminated intravascular coagulation (DIC). * Class III or IV heart disease (New York Heart Association classification).

Study Objectives The purposes of this study are: To determine the maximum tolerated dose of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine in patients with advanced or metastatic transitional cell carcinoma of the urothelium; To determine the safety of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine and any side effects that might be associated with the combination of these drugs; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can help patients with advanced bladder cancer live longer; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can make your tumor smaller or disappear, and for how long. Conditions: Carcinoma, Transitional Cell Intervention / Treatment: DRUG: Pemetrexed, DRUG: Gemcitabine, DRUG: Platinol 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: * Biopsy-proven metastatic bladder cancer * No prior chemotherapy for metastatic disease except before or after surgery, which was completed 6 months before enrollment * Prior radiation allowed, if it is not the only site of measurable disease and if completed 3 weeks before enrollment * 18 years of age and older Exclusion Criteria: * Pure adeno- or squamous urothelial cancer * Brain metastases that causes symptoms * Have not received treatment within the last 30 days with a drug that has not received regulatory approval for any indication * Inability to take dexamethasone, folic acid or vitamin B12, according to the protocol * Clinically relevant fluid collection in the lungs or abdomen that cannot be controlled

Study Objectives This Phase I study is designed to evaluate the systemic exposure and safety of KX2-391 Ointment in adult subjects when applied to an area of skin containing at least 5 clinically typical, visible, and discrete Actinic Keratosis lesions on the face or balding scalp. Conditions: Actinic Keratoses Intervention / Treatment: DRUG: KX2-391 Ointment 1% 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: * Males and females >=18 years old. * Able to comprehend and are willing to sign an informed consent form (ICF). * At least 5 clinically typical, visible, and discrete AKs on 25 cm2 of the face or balding scalp. * Subjects who, in the judgment of the Investigator, are in good general health based on: 1. Medical history 2. Physical examination (PE) findings 3. ECG, clinical chemistry, hematology, and urinalysis results. * In the case of a female of childbearing potential, TKL will initiate two forms of birth control at Screening and that at least one had to be in place for 30 days prior (oral/implant/injectable/transdermal contraceptives, intrauterine device (IUD), condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy, tubal ligation). Abstinence or vasectomies are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes; * Females of childbearing potential, must agree to continue to use two methods of birth control for 30 days following the last dose of study treatment; * In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS); * In the case of sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment; * In the case of a female of non-childbearing potential, has had a hysterectomy or is postmenopausal (at least 2 years with no menses prior to enrollment); * All subjects must agree not to donate sperm or eggs or attempt conception from Screening through 90 days following their last dose of study treatment; * Willing to avoid direct sun or ultraviolet (UV) light exposure to the face or scalp. Exclusion Criteria: * Clinically atypical and/or rapidly changing AK lesions on the treatment area, e.g., hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on two previous occasions) and/or cutaneous horn. * Location of the treatment area: 1. Within 5 cm of an incompletely healed wound 2. Within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) * Been previously treated with KX2-391 ointment. * Has QTcF >450 ms for males and 470 ms for females or other relevant pathological changes in the ECG, in the opinion of the Investigation, at Screening. * Anticipated need for in-patient hospitalization or in-patient surgery during the study. * Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for AK within 2 cm of the treatment area, within 8 weeks prior to the Screening visit. * Use of the following therapies and/or medications within 2 weeks prior to the Screening visit: 1. Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within 2 cm of the selected treatment area 2. Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within 2 cm of the selected treatment area 3. Topical salves (non-medicated/non-irritant lotion and cream are acceptable) or topical steroids within 2 cm of the selected treatment area; artificial tanners within 5 cm of the selected treatment area. * Use of the following therapies and/or medications within 4 weeks prior to the Screening visit: 1. Treatment with immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/interferon inducers 2. Treatment with systemic medications that suppress the immune system (e.g., cyclosporine, prednisone, methotrexate, alefacept, infliximab) 3. Therapy/treatment with UVA or UVB. * Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit. * A history of sensitivity and/or allergy to any of the ingredients in the study medication. * A skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., scarring, open wounds) that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the subject to unacceptable risk by study participation. * Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would exposure the subject to unacceptable risk by study participation. * Females who are pregnant or nursing. * Participated in an investigational drug trial during which an investigational study medication was administered within 30 days or 5 half-lives or the investigational product, whichever is longer, before dosing.

Study Objectives Standard treatment for locally advanced cancer of the rectum is preoperative chemoradiotherapy with 5-Fluorouracil (5-FU) plus 4 cycles of postoperative chemotherapy with 5-FU. According to our previous study (CAO/ARO/AIO-94, published in the New England Journal of Medicine 2004; 351:1731-40) this treatment results in only 6% of local failures, yet, still 36% of all patients develop distant metastasis. Therefore, our new study (CAO/ARO/AIO-04) incorporates new drugs, i.e. 5-FU + oxaliplatin, in an effort to improve the control of distant metastases. It is our hypothesis that the rate of disease free survival will improve by 5 to 8% after 3 years of follow-up. Conditions: Rectal Neoplasms Intervention / Treatment: DRUG: 5-FU and oxaliplatin, DRUG: 5-FU Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Minimum age: 18 years * Histologically proven, advanced primary carcinoma of the rectum (tumor ? 12cm from the anal verge, with clinically staged T3/4 or any node-positive disease * No prior therapy except a diverting stoma * ECOG PS less than or equal 2 * Adequate bone marrow function: Leukocytes > 3,5 x 10^9/L Absolute neutrophil count > 1,5 x 10^9/L Platelet count > 100 x 10^9/L Hemoglobin > 10 g/dl * Adequate hepatic function: Total bilirubin < 2,0 mg/dl ALAT, ASAT, alkaline phosphatase, gamma-GT < 3 x ULN 7. Serum creatinine < 1,5 mg/dl, creatinine-clearance > 50 ml/min * Written informed consent before randomization Exclusion Criteria: * Pregnant or breast feeding women * Fertile patients without adequate contraception during therapy * Past or ongoing drug abuse or alcoholic excess * Prior chemotherapy * Prior radiotherapy to the pelvis * Prior (within 4 weeks) or concurrent treatment with any other investigational agent * Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * History of severe somatic or psychological diseases: - instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months:* Central nervous system disorders or psychiatric disability including dementia or epileptic disease; * active uncontrolled intercurrent infections or sepsis * Peripheral neuropathy > 2 (NCI CTC AE grading) * Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be discussed with the principal investigator * Chronic diarrhea (> NCI CTC AE-Grad 1) * Known allergy to substances containing platinum compounds * Concurrent use of the antiviral agent sorivudine or chemically related analogues * Known deficiency of dehydropyrimidindehydrogenase (DPD)

Study Objectives The purpose of this study is to determine the clinical benefits of using a rapidly cycling, non-cross reactive regimen of FDA-approved prostate cancer therapeutic agents in the management of castration resistant prostate cancer. The hypothesis is that the identification of optimal combinations and sequencing of therapies can help prevent or delay the development of therapeutic drug resistance, and can be safely tolerated. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Abiraterone acetate, DRUG: Prednisone, DRUG: Radium-223 dichloride, DRUG: cabazitaxel, DRUG: Carboplatin, DRUG: Enzalutamide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Metastatic castrate resistant prostate cancer, defined by progressive disease based on either rising PSA, new bone metastases, or progression of measurable disease on standard imaging, according to PCWG2 guidelines, despite androgen deprivation therapy * Ongoing androgen deprivation therapy with a GnRH analogue, GnRH antagonist, or bilateral orchiectomy * ECOG performance status 0-1 * Serum testosterone level < 50 ng/dL * Absolute neutrophil count > 1,500/μL, platelet count > 100,000/μL, and hemoglobin > 9 g/dL * Creatinine < 2 mg/dL * Total bilirubin < 1 times the upper limit of normal, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <= 1.5 times the upper limit of normal Exclusion Criteria: * History of uncontrolled seizure disorder * Clinically significant cardiovascular disease including: 1. Myocardial infarction or uncontrolled angina within 6 months 2. Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past 3. Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the screening visit * Have used or plan to use from 30 days prior to enrollment through the end of the study medication known to lower the seizure threshold or prolong the QT interval * Major surgery within 4 weeks of enrollment * Radiation therapy within 4 weeks of enrollment * Prior use of abiraterone acetate, enzalutamide, docetaxel, cabazitaxel, carboplatin, or radium-223 for the treatment of castration-resistant disease * Prior docetaxel use in the hormone-sensitive disease setting is allowed, but must be completed >= 4 weeks prior to enrollment * Prior sipuleucel-T use is allowed, but must be completed >= 4 weeks prior to enrollment * Concurrent use of zoledronic acid or denosumab is allowed on study

Study Objectives This multicenter, open-label, dose-escalating study will assess the safety, tolerability, and pharmacokinetics of DMOT4039A in participants with unresectable pancreatic or platinum-resistant ovarian cancer. Cohorts of participants will receive multiple ascending intravenous doses of DMOT4039A. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: DMOT4039A Location: United States, Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Histologically documented, incurable, locally advanced or metastatic disease for which no standard therapy exists, consisting of one of the following: Unresectable pancreatic ductal adenocarcinoma or platinum-resistant ovarian cancer * Measureable disease, defined as at least one bi-dimensionally measurable non-lymph node lesion greater than or equal to (>=) 1 centimeter (cm) in long-axis diameter on spiral computed tomography (CT) scan or at least one bi-dimensionally measurable lymph node measuring >= 1.5 cm in short-axis diameter on spiral CT scan * Adequate hematological, renal and liver function Exclusion Criteria: * Treatment with anti-tumor therapy, including chemotherapy, biologic, experimental or hormonal therapy, within 4 weeks prior to Day 1 * Known active infection * Current Grade >= 2 toxicity (except for alopecia, anorexia and fatigue) from prior therapy or Grade >= 2 neuropathy * Untreated or active cerebral nervous system metastases * Pregnant or breastfeeding women

Study Objectives This study investigates the safety/toxicity and potential anti-tumor activity of sequential administration of nivolumab and escalating doses of the mTOR inhibitor ABI-009 in advanced Ewing's sarcoma, PEComa, epithelioid sarcoma, desmoid tumor, chordoma, non-small cell lung cancer, small cell lung cancer, urethelial carcinoma, melanoma, renal cell carcinoma, squamous cell carcinoma of head and neck, hepatocellular carcinoma, classical Hodgkin's lymphoma, MSI-H/dMMR metastatic colorectal cancer, and tumors with genetic mutations sensitive to mTOR inhibitors Conditions: Ewing Sarcoma, PEComa, Epithelioid Sarcoma, Desmoid Tumor, Chordoma, Non Small Cell Lung Cancer, Urothelial Carcinoma, Melanoma, Renal Cell Carcinoma, Squamous Cell Carcinoma, Hepatocellular Carcinoma, Classical Hodgkin Lymphoma, Colorectal Cancer, MTOR Activating Mutation Intervention / Treatment: DRUG: Nab-Rapamycin, BIOLOGICAL: Nivolumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: A patient will be eligible for inclusion in this study only if all of the following criteria are met: * Patients must have a histologically confirmed diagnosis of Ewing's sarcoma, PEComa, epithelioid sarcoma, desmoid tumor, chordoma, non-small cell lung cancer, small cell lung cancer, urethelial carcinoma, melanoma, renal cell carcinoma, squamous cell carcinoma of head and neck, hepatocellular carcinoma, classical Hodgkin's lymphoma, MSI-H/dMMR metastatic colorectal cancer, and tumors with genetic mutations sensitive to mTOR inhibitors, that is either metastatic or locally advanced and for which surgery is not a recommended option. * Patients must have one or more measurable target lesions by CT scan or MRI. Measurable disease by RECIST v1.1. * Patients must not have been previously treated with a PD-1 inhibitor in combination with an mTOR inhibitor. * Prior treatment (investigational or other), chemotherapy, radiotherapy, surgery, or other therapeutic agents (except immunotherapy and mTOR inhibitors) is allowed, if completed after 5 half-lives or >=28 days prior to enrollment, whichever is shorter. * Eligible patients, >= 12 years, with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Patients must have the following blood chemistry levels at screening (obtained <=14 days prior to enrollment (local laboratory): 1. total bilirubin <=1.5 x upper limit of normal (ULN) mg/dl 2. AST <=2.5 x ULN (<=5 x ULN if attributable to liver metastases) 3. serum creatinine <=1.5 x ULN * Adequate biological parameters as demonstrated by the following blood counts at screening (obtained <=14 days prior to enrollment, local laboratory): 1. Absolute neutrophil count (ANC) >=1.5 × 109/L; 2. Platelet count >=100,000/mm3 (100 × 109/L); 3. Hemoglobin >=9 g/dL. * Serum triglyceride <300 mg/dL; serum cholesterol < 350 mg/dL. * Male or non-pregnant and non-breast feeding female: Females of child-bearing potential must agree to use effective contraception without interruption from 28 days xprior to starting IP and while on study medication and 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 treatment. A second form of birth control is required even if she has had a tubal ligation. Male patients must practice 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. A second form of birth control is required even if he has undergone a successful vasectomy. * Life expectancy of >3 months, as determined by the investigator. * Ability to understand and sign informed consent. * Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures. Exclusion Criteria: A patient will not be eligible for inclusion in this study if any of the following criteria apply: * Concurrent or prior immunotherapy with a PD-1 inhibitor in combination with an mTOr inhibitor. * Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A patient with controlled and asymptomatic CNS metastases may participate in this study. As such, the patient must have completed any prior treatment for CNS metastases >=28 days (including radiotherapy and/or surgery) prior to start of treatment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases. * Active gastrointestinal bleeding. * Pre-existing thyroid abnormality is allowed provided thyroid function can be controlled with medication. * Uncontrolled serious medical or psychiatric illness. Patients with a "currently active" second malignancy other than non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer (staged pT2 with Gleason Score <= 6 and postoperative PSA <0.5 ng/mL), or other adequately treated carcinoma-in-situ are ineligible. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for >=1 year). * Liver-directed therapy within 2 months of enrollment. Prior treatment with radiotherapy (including radio-labeled spheres and/or cyberknife, hepatic arterial embolization (with or without chemotherapy) or cyrotherapy/ablation) is allowed if these therapies did not affect the areas of measurable disease being used for this protocol. * Recent infection requiring systemic anti-infective treatment that was completed <=14 days prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection). * Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy. * Unstable coronary artery disease or myocardial infarction during preceding 6 months. * Receiving any concomitant antitumor therapy. * Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension. * Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to receiving the first dose of ABI-009. * Known Human Immunodeficiency Virus (HIV). * Active Hepatitis B or Hepatitis C. * Non-oncology vaccine therapy used for prevention of infectious disease within 4 weeks of trial enrollment * Autoimmune disease including rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis and motor neuropathy considered to be of autoimmune origin (e.g. Guillain-Barre Syndrome) * Systemic immunosuppression, including HIV positive status with or without AIDS * Skin rash (psoriasis, eczema) affecting > 25% body surface area * Inflammatory bowel disease (Crohn's or ulcerative colitis) * Ongoing or uncontrolled diarrhea within 4 weeks of trial enrollment * Recent history of acute diverticulitis, intraabdominal abscess or gastrointestinal obstruction within 6 months of trial enrollment, which are known risk factors for bowel perforation * Current, active or previous history of heavy alcohol abuse * Pituitary endocrinopathy * Adrenal insufficiency or excess

Study Objectives Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC under daily-life treatment conditions. Conditions: Hepatocellular Carcinoma Intervention / Treatment: DRUG: Sorafenib (Nexavar, BAY43-9006) Location: Italy Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Patients with histologically/cytologically confirmed HCC or radiographically diagnosed as per AASLD criteria, who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made * Patients must have signed the informed consent form * Patients must have a life expectancy of at least 8 weeks Inclusion criteria must follow the approved local product information. Exclusion Criteria: * Prior treatment with sorafenib * Concomitant participation in other clinical studies Exclusion criteria must follow the approved local product information.

Study Objectives This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer. Conditions: Pancreatic Neoplasms Intervention / Treatment: DRUG: nab-Paclitaxel, DRUG: Gemcitabine, DRUG: Chemoradiation, DRUG: Capecitabine, PROCEDURE: Surgery Location: Canada, Italy, Spain, United States, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients * No prior anticancer therapy for pancreatic cancer *>= 18 years of age with a performance status of 0 or 1 *Adequate complete blood counts, hepatic function, and renal function * Signed informed Consent Exclusion Criteria: * Active bacterial, viral, or fungal infection * Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive * Subjects with sensory neuropathy, ascites, or plastic biliary stent. * Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders) * Women who are pregnant or breast feeding

Study Objectives * feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma * collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status Conditions: Rectal Cancer Intervention / Treatment: DRUG: Capecitabine, DRUG: Cetuximab Location: Austria Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age: 18-80 * bioptical confirmed adenocarcinoma of the rectum in operable T3-T4NxM0 status. In spite of infiltration of the neighbouring organs the tumor has to be basically surgically complete resectable * no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of a rectum carcinoma * WHO performance status 0-2 * adequate bone marrow reserve (granulocytes - not more than 1.500/µl; thrombocytes - not more than 100.000/µl) * adequate hepatic function ( bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN) * adequate renal function (creatinin - not more than 1.5 mg/dl) * women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test) * willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (e.g. birth-control pill, loop, condom) during and at least 3 month after conclusion of the study * life expectancy of at least 3 month * signed Informed Consent before recruitment * exclusion of distant metastases at the time of recruitment Exclusion Criteria: * former radiotherapy of pelvis or abdomen * former chemotherapy * any other kind of malign tumor (except adequate treated skin basalioma or in situ cervical carcinoma) in the last 5 years * general contraindication or known hypersensitivity against Cetuximab and/or Capecitabine * Non malign disease, if there is a contraindication with radiotherapy or chemotherapy with Cetuximab and Capecitabine or a resection of the rectum: high-graded cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic disease, significant neurological or psychiatric disorders * florid, serious infections at the time of recruitment * legally limited contractual capability or evidence of neurological or psychiatric disease, if it will constrict the patients compliance in the opinion of the investigator * evidence of lacking cooperation of the patient * pregnant or breast feeding women

Study Objectives The investigators want to know whether the intravenous ascorbic acid would reduce the blood loss during laparoscopic myoma surgery. The investigators randomized patients into intravenous ascorbic acid group and placebo group and examined the blood loss in both groups. Conditions: Uterine Leiomyoma Intervention / Treatment: DRUG: ascorbic acid, DRUG: Normal saline Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * uterine myoma * be planning to laparoscopic myomectomy * images ; the number of myoma <4 * images ; the diameter of the largest myoma <9cm Exclusion Criteria: * be planning other surgery in addition to laparoscopy * clinically significant coagulation abnormality

Study Objectives Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclusion criteria are available. History and physical examination, and laboratory and imaging analyses will be done within 14 days prior to registration. The three cohorts of subjects will receive 50, 75 or 100 grams of intravenous ascorbic acid, three times per week for 8 weeks. Subjects will also have co-administration of the chemotherapy medications, gemcitabine (intravenously) and erlotinib (orally). Approximately 9 to 18 participants will be enrolled in this Phase I study. Conditions: Metastatic Pancreatic Cancer Intervention / Treatment: DRUG: Gemcitabine and Erlotinib, DIETARY_SUPPLEMENT: Intravenous Vitamin C 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: * Metastatic pancreatic cancer * Glucose 6 phosphate dehydrogenase status normal * ECOG performance status 0-2 * Normal creatinine and transaminase * Women of child-bearing potential confirm negative pregnancy test Exclusion Criteria: * Concurrent chemotherapy or radiotherapy * Significant co-morbid disorders * Significant psychiatric symptoms * Prior treatment with gemcitabine * Concurrent chronic use of immunosuppressive agents (methotrexate, cyclosporine,corticosteroids) * Regular use of nonsteroidal anti-inflammatory agents * Smoking more than 1 pack per day * Excessive alcohol or drug use * Enrollment in other experimental therapy * Active infection * Patients experiencing ongoing response to recent treatments

Study Objectives The purpose of this study is to test the safety and tolerability of tivozanib (AV-951) and Torisel™ given in combination for renal cell cancer. The study will also assess the effects of the combination of tivozanib (AV-951) and Torisel™ on the tumor. Tivozanib (AV-951) is a VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking blood flow to the tumor. Temsirolimus is an mTOR inhibitor which is approved for the treatment of advanced renal cell carcinoma. Conditions: Renal Cell Carcinoma Intervention / Treatment: DRUG: tivozanib (AV-951) plus temsirolimus 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: * >= 18-year-old males or females * Histologically confirmed renal cell carcinoma with a clear cell component * Documented progressive disease * Measurable disease by RECIST criteria * No more than 1 prior VEGF receptor targeted therapy; no prior treatment with temsirolimus or other drugs targeting the mTOR pathway * Karnofsky performance status > 70%; life expectancy >= 3 months * Ability to give written informed consent Exclusion Criteria: * Known hypersensitivity to temsirolimus or its metabolites (including sirolimus), polysorbate 80, or to any other component of the temsirolimus formulation * Primary CNS malignancies; active CNS metastases * Hematologic malignancies (including leukemia in any form, lymphoma, and multiple myeloma) * Any of the following hematologic abnormalities: * Hemoglobin < 9.0 g/dL * ANC < 1500 per mm3 * Platelet count < 100,000 per mm3 * Any of the following serum chemistry abnormalities: * Fasting serum cholesterol > 350 mg/dL * Fasting triglycerides > 400 mg/dL * Total bilirubin > 1.5 × ULN * AST or ALT > 2.5 × ULN (or > 5 x ULN in subjects with liver metastasis) * Serum albumin < 3.0 g/dL * Creatine > 1.5 × ULN (or calculated CLCR <50 mL/min/1.73 m2) * Proteinuria > 2.5 g/24 hours or 3+ with urine dipstick * Significant cardiovascular disease, including: * Active clinically symptomatic left ventricular failure * Active hypertension (diastolic blood pressure > 100 mmHg). Subjects with a history of hypertension must have been on stable doses of anti-hypertensive drugs for >= 4 weeks * Uncontrolled hypertension: Blood pressure >140/90 mmHg on 2 or more antihypertensive medications * Myocardial infarction within 3 months prior to administration of first dose of study drug * Subjects with delayed healing of wounds, ulcers, and/or bone fractures * Pulmonary hypertension or pneumonitis * Serious/active infection; infection requiring parenteral antibiotics * Inadequate recovery from any prior surgical procedure; major surgical procedure within 6 weeks prior to study entry * Uncontrolled psychiatric disorder, altered mental status precluding informed consent or necessary testing * Inability to comply with protocol requirements * Ongoing hemoptysis or history of clinically significant bleeding * Cerebrovascular accident within 12 months of study entry, or peripheral vascular disease with claudication on walking less than 1 block * Deep venous thrombosis or pulmonary embolus within 6 months of study entry and/or ongoing need for full-dose oral or parenteral anticoagulation * Subjects with a "currently active" second primary malignancy other than non-melanoma skin cancers. Subjects are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy and are considered by their physician to be < 30% risk of relapse. * Pregnant or lactating women * Known concomitant genetic or acquired immune suppression disease such as HIV Prohibited medications: * VEGF receptor (VEGFR) targeted therapy within 4 weeks prior to and during study * Other signal transduction inhibitors, monoclonal antibodies, etc., within 4 weeks prior to and during study * Immunotherapy or biological response modifiers within 4 weeks prior to and during study * Systemic hormonal therapy within 4 weeks prior to and during study, with the exception of: * Hormonal therapy for appetite stimulation or contraception * Nasal, ophthalmic, and topical glucocorticoid preparations * Oral replacement therapy for adrenal insufficiency * Low-dose maintenance steroid therapy for other conditions * Herbal preparations/supplements (except for a daily multivitamin/mineral supplement not containing herbal components) within 2 weeks prior to or during study * Any experimental therapy 4 weeks prior to and during study * Radiotherapy: * At least 2 weeks since prior local radiation therapy (ie, involving <25% of bone marrow) at the time of study entry * At least 4 weeks since prior radiation therapy involving >= 25% of bone marrow * Treatment with CYP3A4 inducers or inhibitors during the study

Study Objectives Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks. Conditions: Breast Cancer Intervention / Treatment: DRUG: Liposomal Doxorubicin, DRUG: Cyclophosphamide, DRUG: Trastuzumab Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must sign an informed consent before of specific procedures of clinical trial. * Patients with histologically confirmed breast cancer and overexpression of Her2neu. * Age> 18 years. * Eastern Cooperative Oncology Group (ECOG) equal or < 2. * Patients have not been treated previously with chemotherapy for metastatic disease. * Patients must have at least one measurable lesion according to RECIST criteria. * Patients should have an adequate organ function to tolerate chemotherapy. Exclusion Criteria: * Patients with hypersensitivity reactions to any of the medications of the clinical trial. * Patients who are pregnant or lactating are not eligible. * Hepatic disease. * Not controlled active infection * Symptomatic metastatic brain cancer * Previous adjuvant treatment with anthracyclines with a total accumulated dose > 300 mg/m2 (Doxorubicin) or > 600 mg/m2 (Epirubicin)

Study Objectives The Purpose of this study is to determine the response to two different strengths of a topical gel containing nitroglycerin in patients with Raynaud's disease. Conditions: Raynaud's Disease, Raynaud's Disease Secondary to Scleroderma, Raynaud's Disease Secondary to Autoimmune Disease Intervention / Treatment: DRUG: MQX-503 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: DOUBLE

Inclusion Criteria: * Outpatients, 18 to 75 years * Clinical Diagnosis of Raynaud's, or observed event by study physician, or symptoms with reduced blood flow as meausred using laser doppler equipment * Agree to have test gels applied to finger * Discontinue current vasodialator therapeis for Raynaud's treatment * Four weeks from last clinical trial participation * Agree not to use any other investigational medications or therapies to treat Raynaud's and its symptoms while participating in this study including other dosages or forms of nitroglycerin, isosorbide dinitrate, fenoldopam mesylate, milrinone lactate, nifedipine, diltiazem, felodipine, nimodipine, nisoldipine, and verapamil * Negative pregnancy test for women prior to study start and agree to use effective contraception throughout * Must be able to give written informed consent and comply with all study requirements Exclusion Criteria: * Concurrent use of any nitrate medication or medications known to interact with Nitroglycerin such as sildenafil, and other treatments for erectile dysfunction * Patients who have a known allergy to Nitroglycerin or common topical gel ingredients * Patients with a history of migraine, cluster or vascular headaches, or those who suffer from chronic pain * Patients with a history of an unstable medical problem or any current condition that would interfere in participation in the study * Patients unable to complete pain assessment instructions * Patients who in the last three months have had a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension * Patients who have participated in another investigational drug study within four weeks of the first study treatment * Patients with out of range laboratory screening values * Patients who have had major abdominal, thoracic or vascular surgery within six months of the first study treatment * Patients with open lesions or skin conditions where gel is to be applied * Pregnant or nursing women * Women who will not agree to comply with contraceptive requirements * Patients with a history of poor compliance, poor cooperation or unreliability

Study Objectives This pilot phase I trial studies vitamin D levels in the skin of healthy subjects after oral supplementation. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of cholecalciferol, a vitamin D, may keep skin cancer from forming. Conditions: Healthy, no Evidence of Disease, Skin Cancer Intervention / Treatment: DRUG: cholecalciferol Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: PREVENTION Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Documented insufficient serum levels of 25-hydroxyvitamin D =< 30.0 ng/mL * At least moderate sun-damaged skin on the mid-upper right dorsal forearm * Karnofsky performance status of at least 80% * Leukocytes âÃÂ¥ 3,000/ÃüL * Absolute neutrophil count âÃÂ¥ 1,500/ÃüL * Platelets âÃÂ¥ 100,000/ÃüL * Total bilirubin âä 2.0 mg/dL * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< institutional upper limit of normal (ULN) * Creatinine âä 1.4 mg/dL * Serum calcium 8.4-10.6 mg/dL * Parathyroid hormone (PTH): male 8.3-10.4 mg/dL; female 8.4-10.6 mg/dL * Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence; surgical sterilization; or at least one year post-menopausal) prior to study entry and for the duration of study participation * Skin phototype II or III as defined according to their skin response to sunlight: * Skin phototype II will always burn, and tan minimally after 45-60 min of unprotected exposure to the summer sun between 12-1pm * Skin phototype III will sometimes burn, and almost always tan after 45-60 min of unprotected exposure to the summer sun between 12-1pm * Ability to understand and willingness to sign written informed consent * Participants may not have acute or chronic hypervitaminosis D or hypercalcemia * No history of increased arterial calcification or atherosclerosis, sarcoidosis, histoplasmosis, hyperparathyroidism, lymphoma, or kidney disease * No current use of digoxin (Lanoxin, digitalis), cholestyramine (Prevalite, Questran), colestipol (Cholestid), oral steroids (prednisone and others), and antacids that contain magnesium * Participants may not be receiving any other investigational agents; if they have completed a clinical-intervention trial recently, there must be a 30-day period between completing the previous study and entering this study * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cholecalciferol, lidocaine, or xylocaine * No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant and breastfeeding women are excluded from this study * No invasive cancer or cancer treatment within the past five years, except non-melanoma skin cancer * No immunosuppression by virtue of medication or disease; this includes acquired immune deficiency syndrome (AIDS) patients, subjects taking oral prednisone, and subjects on immunosuppressants/immunomodulators (cyclosporine, chemotherapeutic agents, or biologic therapy), as determined by the examining investigator/co-investigator * Unwilling or unable to refrain from taking herbal medicines or above-standard vitamin or mineral during the study * A standard daily multivitamin/mineral supplement is acceptable if it contains ÃâÃä 600 IU of vitamin D, or ÃâÃä the recommended dietary allowance (RDA) of calcium, and the subject has been taking a stable dose for at least 30 days * Potential subjects who are taking above-standard doses of supplements may be re-considered for participation after a 30-day wash-out period * No participants who have used tanning beds or other methods to promote sun-tanning within 6 months of study entry; such practices may not be undertaken during participation in the study * Participants unwilling to minimize their exposure to sunlight by applying sunscreen/sunblock or by wearing clothing to shield their skin, during outdoor activities, while they are enrolled in the study * Individuals receiving concurrent topical therapy with retinoids, steroids, 5-fluorouracil, Levulan, Vaniqa (eflornithine), Solaraze, or Imiquimod (AldaraÃÃî) within 30 days prior to study enrollment will be excluded; subjects may be reconsidered for eligibility 30 days after the last treatment * Individuals who have had treatment for basal cell carcinoma or squamous cell carcinoma on the skin of the right forearm within six months prior to evaluation for the study will not be eligible; these subjects will be encouraged to return for re-evaluation once the six-month period is over

Study Objectives To determine whether CC-10004, a phosphodiesterase inhibitor, is useful in treating chronic cutaneous sarcoidosis. Conditions: Sarcoidosis, Cutaneous Sarcoidosis Intervention / Treatment: DRUG: CC-100004 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Must understand and voluntarily sign an informed consent form * Must be male or female and aged >= 18 years at time of consent * Must be able to adhere to the study visit schedule and other protocol requirements * Patients with sarcoidosis as defined by the ATS/ERS/WASOG statement on sarcoidosis as defined by the clinical presentation consistent with sarcoidosis, biopsy finding granulomas, and no alternative for the cause of the granulomas, such as tuberculosis * Patients must have chronic cutaneous skin lesions while taking chronic therapy (corticosteroids, methotrexate (max 10mg/week), azathioprine, hydroxychloroquine, cyclophosphamide, minocycline, doxycycline and chloroquine), in which the dose has not been altered in the three months prior to starting the study. * Must have two visits within the previous 1-6 months (at least one month apart) with stable skin lesions, such as a SASI score was within one point for each of the features of the lesion. * Must meet the following laboratory criteria: * Hemoglobin > 9 g/dL * Hematocrit >= 27% * White blood cell (WBC) count >= 3000 (>= 3.0 X 109/L) and < 20,000 (< 20 X 109/L) * Neutrophils >= 1500 (>= 1.5 X 109/L) * Platelets >= 100,000 (>= 100 X 109/L) * Serum creatinine <= 1.5 mg/dL (<= 132.6 μmol/L) * Total bilirubin < 2.0 mg/dL * Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) < 1.5x upper limit of normal (ULN) * Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception while on study medication: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive or vasectomized partner. A FCBP must agree to have pregnancy tests every 28 days while on study medication. * Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in sexual activity with FCBP while on study medication and for 84 days after taking the last dose of study medication. Exclusion Criteria: * History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases (not including pulmonary sarcoidosis) * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study * Pregnant or lactating female * History of active Mycobacterium tuberculosis infection (any subspecies) within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated. * History of incompletely treated latent Mycobacterium tuberculosis infection (as indicated by a positive Purified Protein Derivative [PPD] skin test or in vitro test [T-SPOT®.TB, QuantiFERON Gold®]. * Clinically significant abnormality on the chest x-ray (CXR) at screening not due to sarcoidosis * Use of any investigational medication within 28 days. * Any clinically significant abnormality on 12-lead ECG at screening * Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C laboratory test result indicating active infection at screening * History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma(s) and/or fewer than 3 treated squamous-cell skin carcinomas) * Use of infliximab, etanercept, adalimumab, pentoxifylline, or thalidomide in the prior three months.

Study Objectives The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic breast imaging system and color imaging of transmission data (sound speed and attenuation). SoftVue™ is not intended to be used as a replacement for screening mammography. SoftVue uses non-ionizing ultrasound energy to generate tomographic image volumes of the whole breast. While the patient lays prone on a padded table with one breast comfortably submerged in a bath of warm water, a ring-shaped transducer, 22 cm in diameter, encircles the breast and pulses low-frequency sound waves through the water and into the breast tissue. More than 2000 elements in the curvilinear transducer's 360 degree array emit and receive ultrasound signals to analyze echoes from the breast anatomy in all directions, from the chest wall to the nipple. Not only does SoftVue capture data from the reflection of the sound waves off of tissue boundaries and structures within the breast, but because the transducer surrounds the whole breast, SoftVue also captures signals that are transmitted through the breast. This additional transmission data enhances the visualization of the anatomic structure of the breast tissue and is not currently available in any other commercially marketed breast ultrasound device. This prospective, multicenter, multi-arm, clinical case collection program is IRB-approved and will be conducted in compliance with Good Clinical Practice, the Declaration of Helsinki and all applicable regulatory requirements. Arm 1 aims to collectively enroll up to 17,500 women at a total of up to 8 clinical sites. The design of this protocol is strictly limited to case collection; all investigational and statistical plans for future analyses will be prepared and registered separately, if they are applicable to the requirements of FDAAA 801. Arm 1 is limited to the cohort of asymptomatic women, with heterogeneously or extremely dense breast parenchyma (BI-RADS breast composition category c or d). Matched triads of 2D digital mammography (FFDM), 3D digital mammography (DBT), and SoftVue automated whole breast ultrasound (SV)exams, from the same patient, with demographic information and clinical outcome data, will be collected during the same screening imaging episode. Ultrasound characteristics for all types of lesions, whether they are benign or malignant, will be collected, as well as objective and subjective breast density composition data. The exams and clinical data accumulated in this prospective case collection (PCC) protocol will populate a database from which future investigations may be designed for peer reviewed publication, development of user training curriculums, building teaching case, and creating new marketing materials for SoftVue.A subset of exams will be sampled from Arm 1 for use in ROC Reader Study (protocol DMT-2015.002), which will be separately registered and is designed to evaluate the safety and efficacy of a new screening indication for use of SoftVue™ as an adjunct to screening mammography. The results of this ROC Reader Study will be submitted to the FDA for their consideration of a PMA application for SoftVue. Conditions: Breast Neoplasms Intervention / Treatment: DEVICE: Routine Full-Field Digital Mammography, DEVICE: Routine Digital Breast Tomosynthesis, DEVICE: Automated Whole Breast Ultrasound Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria * Female * Any race or ethnicity * Age >= 18 years * Asymptomatic * Complete screening FFDM and DBT views * BI-RADS density composition category c or d * Willing to comply with protocol and follow-up recommendations as described in consent form, including the next annual screening exam in 12 months Exclusion Criteria * Weight exceeds 350lbs * Currently pregnant or lactating by patient self-report * Weeping rash, open wounds, or unhealed sores on the breast * Bilateral mastectomy * Unable to lay prone on the scan table for up to 15 minutes * History of breast cancer diagnosis and/or treatment (chemotherapy, surgery, and/or radiation) in the past 12 months

Study Objectives The aim of this study is to evaluate the performance of a double labelling method using isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN) in a series of 100 patients with infiltrative breast cancer justifying SLN excision. Method and patients: SLN excision will be performed on 100 patients treated for infiltrative breast cancer. After preoperative methylene blue dye injection and lymphoscintigraphy, individual localization of the radioactive and stained nodes will be performed. After the surgery, SLN will be submitted to serial analysis and immunohistochemistry. A comparison of the two methods and an economical evaluation of the complete procedure will be performed. Conditions: Infiltrative Breast Cancer Intervention / Treatment: DRUG: Methylene blue (1%), DRUG: Rhenium sulfure, PROCEDURE: Surgical procedure, PROCEDURE: Anatomo-pathologic procedure Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * patients with infiltrative breast cancer (diagnosed pre-operatively by core biopsy) * approval and informed consent Exclusion Criteria: * chemotherapy * locoregional radiotherapy * prevalent axillary lymph node

Study Objectives This is an open-label study that includes two substudies of random distribution. First,a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers.Depending on the expression of these markers, the patients will be characterize as group 1 (Luminal A phenotype) or group 2 (Basal phenotype) and a random assignment will be performed to standard or experimental treatment. Conditions: Breast Cancer Intervention / Treatment: DRUG: Epirubicin, DRUG: Cyclophosphamide, DRUG: Docetaxel, DRUG: Exemestane, DRUG: Goserelin, DRUG: Carboplatin Location: Spain Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Written informed consent. * Breast cancer with histological diagnosis. * Negative Human Epidermal Growth Factor Receptor 2 (HER2) tumours defined as immunohistochemistry (IHQ) 0,1+. * No evidence of suspicion of metastatic disease. * Age >= 18 years old. * Performance status (Karnofsky index) >= 80 (ECOG 0,1). * Adequate cardiac function by ECG in the previous 12 weeks. * Hematology: neutrophils >= 1,5 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >= 10 g/dl. * Adequate hepatic function: total bilirubin <= 1x Upper Normal Limit (UNL); Aspartate aminotransferase (AST) (SGOT) and Alanine aminotransferase (ALT) (SGPT) <= 2.5 x UNL; alkaline phosphatase <= 2.5 x UNL. * Adequate renal function: creatinine <= 1 x UNL; creatinine clearance >= 60 ml/min. * Patients able to comply with study treatment and follow-up. * Negative pregnancy test in the previous 14 days. Exclusion Criteria: * HER2 positive tumours (defined as IHQ 3+ or positive fluorescence in situ hybridization [FISH]). * Prior systemic therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy). * Prior treatment with anthracyclines or taxanes (paclitaxel, docetaxel) for any previous malignancy. * Prior radiotherapy for breast cancer. * Bilateral invasive breast cancer. * Pregnant or lactating women. * Previous grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria [NCICTC]). * Other serious comorbidities: congestive heart failure or unstable angina; prior history of myocardial infarction in previous year; uncontrolled hypertension (HT); high risk arrhythmias; history of significant neurological or psychiatric disorders; uncontrolled active infection; active peptic ulcer; unstable diabetes mellitus; dyspnea at rest; or chronic therapy with oxygen. * Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma. * Chronic treatment with corticosteroids. * Contraindications for administration of corticosteroids. * Concomitant treatment with other therapy for cancer. * Males.

Study Objectives The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength. Conditions: Cachexia, Non-Small Cell Lung Cancer Intervention / Treatment: DRUG: Anamorelin HCl, DRUG: Placebo Location: Hungary, Belarus, Canada, Germany, Italy, Netherlands, Spain, Ukraine, Serbia, United States, Belgium, Slovenia, Czechia, Russian Federation, France, Poland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Documented diagnosis of unresectable Stage III or Stage IV NSCLC * Patients may be receiving maintenance chemotherapy * Patients planning to initiate a new chemotherapy and/or radiation therapy regimen may do so only within ± 14 days of randomization * Patients may have completed a chemotherapy and/or radiation therapy and/or have no plan to initiate a new regimen within 12 weeks from randomization; at least 14 days must elapse from the completion of the chemotherapy and/or radiation therapy prior to randomization * Involuntary weight loss of >=5% body weight within 6 months prior to screening or a screening body mass index (BMI) <20 kg/m2 * Body mass index <=30 kg/m2 * Life expectancy of >4 months at time of screening * ECOG performance status <=2 * Adequate hepatic function, defined as AST and ALT levels <=5 x upper limit of normal * Adequate renal function, defined as creatinine <=2 x upper limit of normal, or calculated creatinine clearance >30 ml/minute * Ability to understand and comply with the procedures for the HGS evaluation * If a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method) * Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures Exclusion Criteria: * Other forms of lung cancer (e.g., small cell, mesothelioma) * Women who are pregnant or breast-feeding * Known HIV, hepatitis (B&C), or active tuberculosis * Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization; patients must be well recovered from acute effects of surgery prior to screening; patients should not have plans to undergo major surgical procedures during the treatment period * Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol * Inability to readily swallow oral tablets; patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded * Has an active, uncontrolled infection * Has uncontrolled diabetes mellitus * Has untreated clinically relevant hypothyroidism * Has known or symptomatic brain metastases * Receiving strong CYP3A4 inhibitors within 14 days of randomization * Receiving tube feedings or parenteral nutrition (either total or partial); patients must have discontinued these treatments for at least 6 weeks prior to Day 1, and throughout the study duration * Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation * Has had previous exposure to Anamorelin HCl * Patients actively receiving a concurrent investigational agent

Study Objectives A phase1 study to evaluate the PK (single dose and multiple doses) and safety of talazoparib 1 mg Once Daily in Chinese adult participants with advanced solid tumors. A maximum of approximately 15 participants will be enrolled such that approximately 12 evaluable participants complete the study. Conditions: Neoplasms Intervention / Treatment: DRUG: talazoparib Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histological or cytological diagnosis of locally advanced or metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available. * ECOG Performance Status 0 or 1. * Adequate Bone Marrow, Renal and Liver Function. Exclusion Criteria: * Participants with brain metastases. * Current or anticipated use of P gp inhibitor and/or inducer within 7 days prior to study intervention from lead-in to end of Cycle 1; concomitant use of potent P gp inhibitor after Cycle 1 until the end of treatment. * Prior treatment with a PARP inhibitor.

Study Objectives This is an open-label, single arm, multi-center, multi-national, adaptive design, dose-escalation Phase 1/2 study to determine the maximum tolerated dose (MTD) of temsirolimus with daily neratinib, and to determine the safety and efficacy of this combination when given to patients with advanced breast carcinoma, specifically trastuzumab-refractory HER2-amplified disease or triple-negative disease. Conditions: Breast Cancer Intervention / Treatment: DRUG: Temsirolimus, DRUG: Neratinib Location: Spain, United Kingdom, Denmark, United States, Hong Kong, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Phase I HER2-amplified Cohort * HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or fluorescence in situ hybridisation (FISH) (>=2.0) * Previously received trastuzumab as part of a regimen in the adjuvant or metastatic setting with evidence of progression. Washout period for trastuzumab of 14 days. * May have previously received lapatinib as part of a regimen in the adjuvant or metastatic setting with evidence of progression of disease. Washout period for lapatinib of 14 days. * Radiographic progression of disease while on treatment with trastuzumab or lapatinib as defined by RECIST 1.1 criteria. * No restriction on prior chemotherapy regimens for advanced stage disease. No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted. Phase II HER2-amplified Cohort * HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH (>=2.0). * Previously received trastuzumab as part of a regimen in the adjuvant or metastatic setting with evidence of progression. Washout period for trastuzumab of 14 days. * May have previously received lapatinib as part of a regimen in the adjuvant or metastatic setting with evidence of progression of disease. Washout period for lapatinib of 14 days. * Radiographic progression of disease while on treatment with trastuzumab as defined by RECIST 1.1 criteria. * Prior therapy inclusion: no more than four prior chemotherapy regimens allowed for advanced stage disease. No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted. Phase II Triple-negative Cohort - As of 2/10/12, this cohort is closed to accrual * Invasive adenocarcinoma negative for estrogen receptor (<5%) and progesterone receptor (<5%) expression and a lack of HER2 overexpression and/or amplification as determined by immunohistochemistry (<3+) or FISH (<2.0). * Prior therapy inclusion: no more than four prior chemotherapy regimens allowed for advanced stage disease. No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted. Phase II HER2-Positive Cohort with dose escalation * HER2 overexpression and/or amplification as determined by immunohistochemistry (IHC) (3+) or FISH (>=2.0). * Previously received trastuzumab as part of a regimen in the adjuvant or metastatic setting with evidence of progression. Washout period for trastuzumab of 14 days. * May have previously received lapatinib as part of a regimen in the adjuvant or metastatic setting with evidence of progression of disease. Washout period for lapatinib of 14 days. * Radiographic progression of disease while on treatment with trastuzumab as defined by RECIST v 1.1. * Prior therapy inclusion: no restriction on prior chemotherapy regimens for advanced stage disease. No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted. Inclusion Criteria for all subjects (HER2-Amplified and Triple-negative) * Patients with a diagnosis of invasive adenocarcinoma of the breast confirmed by histology or cytology at MSKCC. * Metastatic disease that is or has been pathologically documented. * At least one measurable metastatic lesion according to RECIST 1.1 criteria. Ascites, pleural effusions, and bone metastases are not considered measurable. Minimum indicator lesion size >= 10 mm by helical CT or >= 20 mm by conventional techniques. * Pathological nodes must be >= 15 mm by the short axis to be considered measurable. * Age >= 18, as no dosing or adverse event data are currently available on the use of neratinib or temsirolimus in patients <18 years of age, children are excluded from this study. * Patients must be willing to discontinue sex hormonal therapy, e.g., birth control pills, hormonal replacement therapy, prior to enrollment. Women of childbearing potential must consent to effective contraception while on treatment and for a period thereafter. * Negative serum human chorionic gonadotropin pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after menopause. * Asymptomatic, central nervous system metastases are permitted if patients remain clinically stable after discontinuation of steroids and anticonvulsants for 3 months. * Eastern Cooperative Oncology Group (ECOG) performance status score of <=2. * Patients must have normal organ and marrow function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) <=2.5x institutional upper limit of normal except for patients with liver metastases. For patients with liver metastases, AST/ALT/Alkaline phosphatase <=5.0x institutional upper limit of normal. Total bilirubin within institutional limits except for patients with liver metastases. For patients with liver metastases, total bilirubin <=1.5x institutional upper limit of normal. Creatinine clearance within normal limits or >= 60 mL/min, prothrombin time and partial thromboplastin time <=1.5x institutional upper limit of normal except for patients on Coumadin or low molecular weight heparin, leukocytes >=3,000/μl, absolute neutrophil count >=1,000/μl, and platelets >=75,000/μl * Able to swallow and retain oral medication. The following criteria were removed for all patients in Protocol Amendment 10, and are only applicable to first 34 HER2+ patients in Phase 2 who are not subject to dose-escalation of temsirolimus: * Able and willing to consent for biopsy of metastatic breast cancer prior to treatment. Consent to preservation of frozen and fixed samples of tumor cores for evaluation. (HER2-amplified patients who have previously provided samples of metastatic breast cancer as part of institutional review board #06-163 will be exempt) * Consent to evaluation of primary tumor biopsy specimen. Exclusion Criteria: * Potential subjects will be excluded from enrollment into this study if they meet any of the following criteria: * Patients receiving any concurrent anticancer therapy or investigational agents with the intention of treating breast cancer. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to neratinib or temsirolimus. * Unable to consent to biopsy of metastatic disease or for whom a biopsy would be medically unsafe. * Women who are pregnant or breast feeding. * Life expectancy <3 months. * Completion of previous chemotherapy regimen <3 weeks prior to the start of study treatment. Prior hormonal therapy must be discontinued prior to treatment start. Biologic therapy with bevacizumab for the treatment of metastatic disease must be discontinued >=3 weeks from the start of protocol treatment. * Concurrent radiotherapy is not permitted for disease progression on treatment on protocol, but might be allowed for pre-existing non-target lesions with approval from the principal investigator of the trial. * Concurrent medical conditions which may increase the risk of toxicity, including ongoing or active infection, history of significant bleeding disorder unrelated to cancer (congenital bleeding disorders, acquired bleeding disorders within one year), HIV-positive or active hepatitis. * History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, and left ventricular ejection fraction less than 50% measured by a multigated blood pool imaging of the heart (MUGA scan) or an echocardiogram (ECHO). * QT corrected interval > 0.47 seconds. * Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, or uncontrolled inflammatory GI disease. * History of an invasive second primary malignancy diagnosed within the previous 3 years, except for stage I endometrial or cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer. * History 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 oral drug intake. * Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures are necessary to participation in this clinical trial.

Study Objectives The National Committee for Quality Assurance has worked with the National Coalition for Cancer Survivorship, the American Society of Clinical Oncology, Oncology Management Services, Independence Blue Cross, and RAND, as well as a broader multi-stakeholder advisory group, to define the Patient-Centered Oncology Care model. The purpose of this project was to pilot and evaluate this model. Specific research questions were: 1. Does Patient-Centered Oncology Care improve patient experiences and quality of care? Does it reduce undesirable events like emergency department visits and hospital stays? 2. How does adoption of Patient-Centered Oncology Care vary across a variety of practices and what factors affect adoption? The demonstration occurred in oncology practices in southeastern Pennsylvania. Practices received implementation support during the 24-month demonstration period. They were evaluated using patient surveys, quality measures, and measures of emergency department and hospital use. Results from these practices were compared in two ways: 1) with their performance before they became oncology medical homes and 2) with other similar practices. Conditions: Neoplasms Intervention / Treatment: OTHER: Pilot of Patient-Centered Oncology Care Location: United States Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria Patients: * Diagnosis of cancer * Receives care at a pilot or comparison oncology practice located in southeastern Pennsylvania that accepts patients with Independence Blue Cross health insurance Exclusion Criteria: * Any person that does not meet any of the inclusion criteria

Study Objectives Identify the best combination of predictive variables that influence ionizing radiation dose and improved image quality through analysis and quantification of PET-CT images in simulators and patients. Conditions: Malignant Neoplasm of Breast, Hodgkin Disease, Non-Hodgkin Lymphoma, Follicular (Nodular), Malignant Neoplasm of Bronchus and Lung, Malignant Neoplasm of Colon, Secondary Neoplasm Malignant and Unspecified Lymph Nodes, Malignant Melanoma of the Skin, Malignant Neoplasm of Small Intestine Intervention / Treatment: OTHER: Image quantify Location: Brazil Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Healthy volunteers; * Both genders; * Age over 18 years; * Clinical indication for PET-CT scan. Exclusion Criteria: * Pregnant women; * Patients who have lesions in the liver metabolically active whether primary or metastatic; * Patients with movement difficulties.

Study Objectives This is an open-label, single-arm, single-center, proof-of-concept study to assess the effects of melatonin on cardiac autonomic activity in melatonin non-proficient pinealectomized patients. Conditions: Pineal Tumor Intervention / Treatment: DRUG: Melatonin Replacement Therapy Location: Brazil Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * patients with pinealectomy and all of the following criteria were considered for admission to the clinical trial: * children, adolescents and young adults 0 months to 25 years of age; * signed written informed consent (patient or his/her parents/legal guardian); * willing and able to complete the clinical trial procedures, as described in the protocol * no recurring tumor after pinealectomy and subsequent chemotherapy * absence of circulating melatonin evaluated by salivary melatonin Elisa assay Exclusion Criteria: * patients with cardiac arrhythmias * potentially non-compliant subjects judged by the investigator to be unsuitable for the study

Study Objectives Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine Conditions: Breast Neoplasms Intervention / Treatment: DRUG: bivatuzumab mertansine Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * female patients aged >= 18 years * patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells * patients with metastases pretreated with anthracyclines and taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments * measurable tumour deposits by one or more radiological techniques (MRI, CT) * life expectancy of at least 6 months * Eastern Cooperative Oncology Group (ECOG) performance score <= 2 * patients must have given written informed consent (which must be consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation) Exclusion Criteria: * hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs * known secondary malignancy requiring therapy * active infectious disease * brain metastases requiring therapy * neuropathy common toxicity criteria (CTC) grade 2 or above * absolute neutrophil count less than 1,500/mm3 * platelet count less than 100,000/mm3 * bilirubin greater than 1.5 mg/dl (> 26 μmol/L, système internationale (SI) unit equivalent) * aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal * serum creatinine greater than 1.5 mg/dl (> 132 μmol/L, SI unit equivalent) * concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug * chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug) * radiotherapy to breast and thorax region within the past four weeks before inclusion or during the trial * women who are sexually active and unwilling to use a medically acceptable method of contraception * pregnancy or lactation * treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug) * patients unable to comply with the protocol

Study Objectives The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer Conditions: HER-2 Positive Breast Cancer, Metastatic Breast Cancer Intervention / Treatment: DRUG: IV LBH589, DRUG: Oral LBH589, DRUG: trastuzumab, DRUG: paclitaxel Location: Italy, Netherlands, United States, Belgium, Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age > 18 year old * Confirmed HER2+ metastatic breast cancer * Prior treatment and progression on trastuzumab * Patients must have adequate organ functions * Eastern Cooperative Oncology Group (ECOG) performance status of <= 1 Exclusion Criteria: * Patients who have had surgery within last 2 weeks prior to starting the treatment * Patients who receive concurrent therapy for brain metastases * Impaired heart function or clinically significant heart disease * Ongoing diarrhea * Liver or renal disease with impaired hepatic or renal functions * Concomitant use of any anti-cancer therapy or certain drugs * Female patients who are pregnant or breast feeding * Patients not willing to use an effective method of birth control Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives The objective of this study is to compare the mechanism of action between adalimumab and methotrexate in subjects with psoriasis. Conditions: Psoriasis Intervention / Treatment: DRUG: Methotrexate, DRUG: Adalimumab (Humira) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: BASIC_SCIENCE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Adults 18-85 years of age with moderate to severe psoriasis, in general good health as determined by the PI based upon the results of medical history, laboratory profile, and physical examination, and who are candidates for systemic or phototherapy * Presence of a psoriatic plaque of >2cm in an area which can be biopsied repeatedly. * Men must agree to avoid impregnating a woman while on this study. * Women are eligible to participate in the study if they meet one of the following criteria: * Women who are postmenopausal (>1 year), sterile, or hysterectomized * Women of childbearing potential must undergo monthly pregnancy testing during the study and agree to use two of the following methods of contraception throughout and for 60 days after the last dose of study drug: * Oral contraceptives * Transdermal contraceptives * Injectable or implantable methods * Intrauterine devices * Barrier methods (diaphragm or condom with spermicide) * Abstinence and Tubal Ligation are also considered a form of Birth control Exclusion Criteria: * Patients <18 or >85 years old * Absence of a psoriatic plaque >2cm in diameter * Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit * Evidence of skin conditions at screening (e.g. eczema) that would interfere with evaluations of the effect of study medication * Inability to understand the consent process * Receipt of any investigational drugs, psoralen+ultraviolet A or oral systemic treatments within 4 weeks of study drug initiation * Biologics within 3 months of study initiation * Topical steroids, topical vitamin A or D analog preparations, Ultraviolet B therapy or anthralin within 2 weeks of study drug initiation. (Exception-stable regimen of class I-II topical steroids on scalp, axillae, and groin) * Methotrexate within 6 weeks of study initiation * History of treatment with adalimumab * History of primary non-response to methotrexate, infliximab or etanercept * History of discontinuation of methotrexate or tumor necrosis factor (TNF) blocker for a safety-related reason that makes it unwise to restart either type of drug * Any internal malignancy within 5 years (excluding fully excised cutaneous basal cell or squamous cell carcinoma) * Pregnancy, not practicing effective birth control, or inability to practice safe sex during the length of the study * Lactation * Subjects who have known hypersensitivity to adalimumab or methotrexate or any of its components or who is known to have antibodies to etanercept * History of alcohol or drug abuse one year before and during the study * Known HIV-positive status or any other immune-suppressing disease * Presence of a grade 3 or 4 infection <30 days prior to the screening visit, between the screening visit and the first day of treatment on study, or any time during the study that in the opinion of the PI would preclude participation in the study * Any grade 3 or 4 adverse event, or laboratory toxicity, at the time of the screening visit or at any time during the study, which in the opinion of the PI would, preclude participation in the study * Serum creatinine >3.0 mg/dL (265 micromoles/L) * Serum potassium <3.5 mmol/L or > 5.5 mmol/L * Serum alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of normal for the lab * Platelet count <100,000/mm3 * White blood cell count <3,000/mm3 * Hgb, Hct, or red blood cell outside 30% of the upper or lower limits of normal for the Lab * Receipt of live vaccines 1 month prior to or while on study * History of tuberculosis, and/or a positive PPD skin test/chest x-ray at screening without appropriate treatment-treatment of latent tuberculosis (for those with positive PPD tests) must be initiated prior to therapy with adalimumab or methotrexate * Chronic hepatitis B or C infection, history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy

Study Objectives This is a multicenter, open-label, Phase 1/2 study to determine the recommended dose and regimen of durvalumab in combination with lenalidomide (LEN) with and without dexamethasone (dex) in adults with newly diagnosed multiple myeloma (NDMM). The study will consist of a dose-finding phase as well as a parallel dose-expansion phase to determine the optimal regimen. \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\* The study was placed on full clinical hold by the United States (US) Food and Drug Administration (FDA) on 05 Sep 2017. The decision by the FDA was based on data from non-Celgene-sponsored studies related to risks of anti-programmed cell death 1 (PD-1), pembrolizumab, in combination with immunomodulatory agents. As the result, the study was closed for further enrollment, and all subjects were discontinued from all study treatments (durvalumab, lenalidomide and dexamethasone). All subjects are being followed for second primary malignancies (SPMs), every 6 months for 5 years after the last subject has been enrolled as per protocol. After stopping data collection in the clinical database, any SPM events will continue to be recorded in the subject's source documents, and reported to Celgene Drug Safety. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Durvalumab, DRUG: Lenalidomide, DRUG: Dexamethasone Location: Finland, Germany, Canada, Italy, Netherlands, Spain, Denmark, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Subjects must satisfy the following criteria to be enrolled into the study: 1. Subject is >= 18 years of age at the time of signing the informed consent form (ICF) 2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements 4. Subject must have documented diagnosis with previously untreated (for cohort C, the induction and consolidation treatment along with the first autologous stem cell transplantation (ASCT) are allowed), symptomatic multiple myeloma (MM) as defined by the criteria below: MM diagnostic criteria (all 3 required); * Monoclonal protein present in the serum and/or urine * Clonal bone marrow plasma cells >=10% or biopsy-proven bony or extramedullary plasmacytoma * Any one or more of the following myeloma defining events: 1. one or more of the following Myeloma-related organ dysfunction (at least one of the following); * (C) Calcium elevation (serum calcium >11.5 mg/dl )(>2.65 mmol/L) * (R) Renal insufficiency (serum creatinine >2 mg/dl)(177 µmol/L or more) or creatinine clearance < 40 ml/min * (A) Anemia (hemoglobin <10 g/dL or >2 g/dL below the lower limit of laboratory normal) * (B) Bone lesions (lytic or osteopenic) one or more bone lesions on skeletal radiography, computed tomography (CT), or positron emission tomography-computed tomography (PET-CT) 2. one or more of the following biomarkers of malignancy: * Clonal bone marrow plasma cell percentage >=60% * Abnormal serum free light-chain ratio >=100 (involved kappa) or < 0.01 (involved lambda) * >1 focal lesions detected by functional imaging including PET/CT and/or whole body magnetic resonance imaging (MRI) AND have measurable disease by protein electrophoresis analyses as defined by the following: * Immunoglobulin G (IgG) MM: Serum monoclonal paraprotein (M-protein) level >= 1.0 g/dl or urine Mprotein level >= 200 mg/24 hours * Immunoglobulin A (IgA) MM: Serum M-protein level >= 0.5 g/dl or urine M-protein level >= 200 mg/24 hours * Immunoglobulin M (IgM) MM (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level >= 1.0 g/dl or urine M-protein level >= 200 mg/24 hours * Immunoglobulin D (IgD) MM: Serum M-protein level >= 0.05 g/dl or urine M-protein level >= 200 mg/24 hours * Light chain MM: Serum M-protein level >= 1.0 g/dl or urine M-protein level >= 200 mg/24 hours 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 6. Females of childbearing potential (FCBP) must: a. Have two negative pregnancy tests as verified by the investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact. b. She must either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and be source documented) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study treatment, during the study therapy (including dose interruptions), and for 90 days after discontinuation of study treatment. c. Refrain from egg cell and blood donation for 90 days after the final dose of durvalumab. 7. Male subjects must : a. Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions and for at least 90 days following study treatment discontinuation, even if he has undergone a successful vasectomy. b. Refrain from sperm and blood donation for at least 90 days after the final dose of durvalumab. 8. For Cohort A subject must be transplant non-eligible (TNE) and meet at least one of the following high risk factors: a. Cytogenetic abnormalities finding in malignant myeloma clone with t(4; 14); and / or del(17p); and / or 1q amplification; and / or t(14:16); or b. International Staging System (ISS) Stage III; or c. Serum lactate dehydrogenase (LDH) > 2*ULN (upper limit of normal). 9. For Cohort B subject must be >= 65 years of age at the time of signing the informed consent form (ICF) and transplant non-eligible (TNE); excluding the subjects who meet the Cohort A criteria. 10. For Cohort C subject must be after first autologous stem cell transplantation (ASCT) for NDMM and meet the following criteria: 1. Have a post-transplant response as Partial response (PR) or better at the time of enrollment to this study; 2. Have one of the following high risk factors at the time of NDMM diagnosis; * Cytogenetic abnormalities finding in malignant myeloma clone with t(4; 14); and / or del(17p); and / or 1q amplification; and / or t(14; 16); or * ISS stage III; or * Serum LDH > 2*ULN; c. Minimal residual disease (MRD) positive (defined as more than 1 malignant cell in 105 cells) measured by ClonoSIGHT™NGS assay of a BMA sample) at the time of enrollment to this study; BMA sample collected at the time of multiple myeloma diagnosis, prior to induction therapy available for central MRD assessment by ClonoSIGHT™NGS assay Exclusion Criteria: * The presence of any of the following will exclude a subject from enrollment: 1. Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid (ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of Cycle 1 Day 1), for Cohort C, the induction and consolidation treatment along with the first Autologous stem cell transplantation (ASCT) are allowed) 2. Any of the following laboratory abnormalities: 1. Absolute neutrophil count (ANC) < 1,000/μL 2. Untransfused platelet count < 75,000 cells/μL 3. Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (SGOT/AST) or alanine aminotransferase (SGPT/ALT) > 2.5*upper limit of normal (ULN) 4. Serum total bilirubin > 1.5*ULN or > 3.0 mg/dL for subjects with documented Gilbert's syndrome 5. Corrected serum calcium >13.5 mg/dL (> 3.4 mmol/L) 3. Renal failure requiring hemodialysis or peritoneal dialysis 4. Any serious medical condition that places the subject at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, subject with unstable cardiac disease as defined by: cardiac events such as myocardial infarction (MI) within the past 6 months, NYHA (New York Heart Association) heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment 5. Peripheral neuropathy >= Grade 2 6. Primary AL (immunoglobulin light-chain) amyloidosis and myeloma complicated by amyloidosis 7. Prior history of malignancies, other than MM, unless the subject has been free of the disease for >= 5 years with the exception of the following non-invasive malignancies: 1. Basal cell carcinoma of the skin 2. Squamous cell carcinoma of the skin 3. Carcinoma in situ of the cervix 4. Carcinoma in situ of the breast 5. Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative 8. Subjects is positive for human immunodeficiency virus (HIV); chronic or active hepatitis B or active hepatitis A, or C 9. Subject had prior exposure to immunotherapy, including, but not limited to, other anti- CTLA-4,anti-PD-1, anti-PD-L1 monoclonal antibody or inhibitor, cell-based therapies, or cancer vaccines 10. Subjects has history of organ or allogeneic stem cell transplantation 11. Subjects who have had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma, or plasma cell leukemia 12. Known or suspected hypersensitivity to the excipients contained in the formulation of durvalumab, lenalidomide, or dexamethasone 13. Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment 14. Received prior treatment (for any reason)with a monoclonal antibody within 5 half-lives of initiating study treatment 15. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of initiating study treatment 16. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment. The following are exceptions to this criterion: 1. Intranasal, inhaled, topical or local steroid injections (eg, intra-articular injection); 2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent; 3. Steroids as premedication for hypersensitivity reactions (eg, computed tomography (CT) scan premedication); 17. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (eg, colitis, Crohn's disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis); myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: 1. Subjects with vitiligo or alopecia; 2. Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or 3. Subjects with psoriasis not requiring systemic treatment; 18. History of primary immunodeficiency 19. Subject has incidence of gastrointestinal disease that may significantly alter the absorption of LEN 20. Receipt of live, attenuated vaccine within 30 days prior to the first dose of durvalumab 21. Unable or unwilling to undergo protocol required thromboembolism prophylaxis(for Cohort C, this will be only for the subjects who have a history of VTE) 22. Females who are pregnant, nursing or breastfeeding, or intend to become pregnant during the participation to the study 23. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 24. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study 25. Any condition that confounds the ability to interpret data from the study

Study Objectives The purpose of this study to evaluate the feasibility of lenalidomide maintenance therapy in patients with relapsed Hodgkin lymphoma after autologous transplant Conditions: Hodgkin Disease Intervention / Treatment: DRUG: Lenalidomide 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: * Patient must have histologically documented classical Hodgkin lymphoma that is recurrent or refractory to standard chemotherapy. * Core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping. If the original diagnostic specimen is not available, relapsed or refractory specimens may be used. Bone marrow biopsies as the sole means of diagnosis are not acceptable; however, they may be used in conjunction with nodal biopsies. Fine needle aspirates (FNA) are not acceptable. Pathology reports must be submitted with the appropriate CRFs, and the actual biopsy specimens are not requested for central review. Patients with cHL have one of the following WHO subtypes: * Nodular sclerosis Hodgkin lymphoma * Lymphocyte-rich Hodgkin lymphoma * Mixed cellularity Hodgkin lymphoma * Lymphocyte-deplete Hodgkin lymphoma cHL patients without one of these subtypes designated cHL not otherwise specified are also eligible. NOTE: Patients with nodular lymphocyte-predominant HL are not eligible. * Patient must have undergone autologous stem cell transplant (ASCT) between 60 and 90 days prior to study registration. * Patient must be >= 18 years old. * Patient must have an ECOG performance status of <= 2 at study entry. * Patient must have adequate hematologic, renal, and hepatic function as defined by: * Absolute neutrophil count >= 1000 / μL * Platelets >= 30,000 / μL * Serum creatinine <= 1.5 X institution upper limit of normal (ULN) * Total bilirubin <= 1.5 mg/dL * AST (SGOT) and ALT (SGPT) <= 3 x ULN (if not attributed to cHL) * Patient must be disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. * Patient must understand and voluntarily sign an informed consent form. * Patient must be able to adhere to the study visit schedule and other protocol requirements. * If a female of childbearing potential (FCBP), patient must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed * A FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). * A FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to prescribing the study drug. The subject may not receive study drug until the Investigator has verified that the results of these pregnancy tests are negative. * If male, patient must agree to use a latex condom during sexual contact with FCBP while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy. * Patient must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin). * Patient must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of Revlimid REMS®. Exclusion Criteria: * Patient who has undergone allogeneic stem cell transplantation. * Patient who shows evidence of progressive disease during salvage chemotherapy or following ASCT. * Patient has any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent him/her from signing the informed consent form. * Patient has any condition, including the presence of laboratory abnormalities, which places him/her at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Patient has used any other anti-cancer drug or therapy, including experimental, within 30 days of initiation of lenalidomide treatment (radiation therapy is allowed within 30 days). * Patient has known hypersensitivity to thalidomide. * Patient developed erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. * Patient has any prior use of lenalidomide. * Patient is known to be positive for HIV or infectious hepatitis, type A, B, or C. * Patient is pregnant or breastfeeding. * Patient has concurrent use of other anti-cancer agents or treatments.

Study Objectives The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma. Conditions: Prostate Cancer Intervention / Treatment: DRUG: ET 743 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * Radiographically documented metastatic disease * Surgical or chemical castration * Prostate specific antigen (PSA) > 5 ng/ml * Castration resistant prostate cancer (CRPC) * One previous taxane-based chemotherapy regimen * Eastern Cooperative Group (ECOG) performance status 0,1 or 2 * Neutrophil count > 1,500/ul * Platelet count > 100,000/ul * Serum bilirubin < 1.0 x upper limit normal (ULN) * Serum alkaline phosphatase < 1.5 x ULN * Asparate aminotransferase/Alanine aminotransferase < 2.5 x ULN * Albumin > 2.5 g/dl * Serum creatinine < 1.5 x ULN * Prior hormonal therapy Exclusion Criteria: * Chemotherapy treatment within 4 weeks of study entry * Patient not employing adequate contraception * Serious illness or medical conditions, specifically: uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within 6 months; active infectious process; chronic active liver disease, including chronic hepatitis B, C or cirrhosis * Current anti-cancer treatment with any non-FDA approved investigational drug

Study Objectives This phase 1-2 trial studies the side effects and best dose of ipilimumab in combination with toll-like receptor 9 (TLR9) agonist SD-101 and radiation therapy in treating patients with recurrent low-grade B-cell lymphoma. Conditions: Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma Intervention / Treatment: BIOLOGICAL: Ipilimumab, DRUG: SD-101, RADIATION: Radiation therapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria * Biopsy-confirmed low-grade B-cell lymphoma, specifically, follicular grade 1 or 2, or 3A marginal zone or small lymphocytic lymphoma; patients must have relapsed from or are refractory to prior therapy * Patients must have at least one site of disease that is accessible for intratumoral injection of SD-101 and of ipilimumab (diameter >= 10mm), percutaneously * Tumor specimens must be available for immunological studies either from a previous biopsy or a new biopsy obtained before the initiation of the study * Patients must have measurable disease other than the injection site or biopsy site * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 [corresponds to Karnofsky Performance Status (KPS) of >= 70] * White blood cell count (WBC) >= 2000/µL (2 x 10^9/L) * Absolute neutrophil count (ANC) >= 1000/µL (0.5 x 10^9/L) * Platelets >= 75 x 10^3/µL (75 x 10^9/L) * Hemoglobin >= 8 g/dL (may be transfused) * Creatinine <= 2.0 x upper limit of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <= 2.5 x ULN for subjects without liver metastasis; <= 5 times for liver metastases * Bilirubin <= 2.0 x ULN (except for subjects with Gilbert's Syndrome, who must have a total bilirubin of less than 3.0 mg/dL) * No active or chronic infection with human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C * Must be at least 4 weeks since treatment with standard or investigational chemotherapy, biochemotherapy, surgery, radiation, cytokine therapy, and 8 weeks since any monoclonal antibodies or immunotherapy, and recovered from any clinically significant toxicity experienced during treatment * Patients of reproductive potential must agree to use an effective (> 90% reliability) form of contraception during the study and for 6 months following the last study drug administration * Women of reproductive potential must have negative urine pregnancy test * Life expectancy greater than 4 months * Able to comply with the treatment schedule * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria * Pre-existing autoimmune or antibody mediated disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, Addison's disease, but excluding the presence of auto-antibodies without clinical autoimmune disease * History of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any origin * Any history of diverticulitis, or evidence of diverticulitis at baseline, including evidence limited to computed tomography (CT) scan only (note diverticulosis is not an exclusion criterion) * Severe psoriasis * Active thyroiditis * History of uveitis * Known history of HIV; patients with Acquired Immunodeficiency Syndrome (AIDS) are excluded * Patients with active infection or with a fever > 38.5 degrees C within 3 days prior to the first scheduled treatment * Central nervous system (CNS) lymphoma * Prior malignancy (active within 5 years of screening) except basal cell or completely excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix * History of allergic reactions attributed to compounds of similar composition to SD-101 or ipilimumab (anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA4] antibodies) * Current anticoagulant therapy (EXCEPTION acetylsalicylic acid <= 325 mg per day allowed) * Treatment with an immunosuppressive regimen of corticosteroids or other immunosuppressive medication (eg, methotrexate, rapamycin) within 30 days of study treatment; note patients with adrenal insufficiency may take up to 5 mg of prednisone or equivalent daily; topical and inhaled corticosteroids in standard doses are allowed * Significant cardiovascular disease [ie, New York Heart Association (NYHA) class 3 congestive heart failure; myocardial infarction with the past 6 months; unstable angina; coronary angioplasty with the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias] * Pregnant or lactating * Any other medical history, including laboratory results, deemed by the investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the results.

Study Objectives The purpose of this study is to examine the feasibility and preliminary efficacy of patient navigation to promote linkage to smoking cessation treatments in cancer patients. Conditions: Tobacco Use Intervention / Treatment: OTHER: Patient navigation-based tobacco harm reduction intervention Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age: >= 18 years of age * Diagnosis of cancer * Current cigarette smoker (smoked cigarettes in last 30 days) * Be able to read and speak English Exclusion Criteria: * Age: < 18 years of age * Unable to read and speak English * Actively using evidence-based smoking cessation treatments * Known decisional impairment

Study Objectives It is expected that RAD001 works in gastric cancer by inhibiting PI3K/AKT/mTOR pathway and Hif1A (hypoxia inducible factor 1, alpha subunit), a key player in angiogenesis and the growth of tumors like renal cell carcinoma.However, RAD001 alone looks not enough to control gastric cancer. By the mechanisms above, RAD001 can show additive or synergistic effect in combination with conventional chemotherapy. In this study, XELOX was selected as a conventional combination chemotherapy because it was proven very active and safe in gastric cancer. Combination of XELOX and RAD001 has been never tried for the treatment of cancer patients yet. So, the optimal dose will be first determined in this phase I study Conditions: Advanced Gastric Cancer Intervention / Treatment: DRUG: RAD001, Capecitabine, Oxaliplatin Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically documented unresectable or metastatic adenocarcinoma of stomach or gastroesophageal junction * No history of chemotherapy or radiation * Age 18 to 70 years old * Estimated life expectancy of at least 3 months * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Adequate bone marrow function (white blood cell counts >3,000/uL, absolute neutrophil count>1,500/uL, Platelets>100,000/uL, Hgb>8 g/dL) * Adequate kidney function (creatinine<1.5 mg/dL) * Adequate liver function (bilirubin<1.5 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level <3 times the upper normal limit (5 times for patients with liver metastasis)) * Signed written informed consent Exclusion Criteria: * Past or concurrent history of neoplasm other than gastric adenocarcinoma except for curatively treated basal cell carcinoma of skin or in situ carcinoma of the cervix uteri * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start * Presence of central nervous system metastasis * Bowel obstruction * Evidence of serious gastrointestinal bleeding * Peripheral neuropathy (NCI CTC AE version 3.0 > Grade I) * History of significant neurologic or psychiatric disorders * Pregnant or lactating women, women of childbearing potential not employing adequate contraception * Other serious illness or medical conditions * Patients with known history of ischemic heart disease and/or with myocardial infarction * Known allergy to study drugs * Administration of drugs showing interaction with RAD001

Study Objectives The purpose of this study is to collect information about the antitumor activity and the safety of capecitabine and thalidomide in patients with colorectal cancer. Conditions: Colorectal Adenocarcinoma Intervention / Treatment: DRUG: Capecitabine, DRUG: Thalidomide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologic proof of colorectal adenocarcinoma with radiological or cytological evidence of stage IV (metastatic) disease * Measurable tumor * Serum creatinine < 1.5 mg/dl * Total bilirubin < 2.0 mg/dl * AST < 5 x ULN * ANC > 1,500/mm3 * Platelets > 100,000/mm3 * Hemoglobin > 9.0 gm/dl * Must have received at least one prior chemotherapy regimen for metastatic colorectal cancer. At least 3 weeks must have passed since the last chemotherapy treatment * 18 years of age or older * ECOG performance status of less than or equal to 2 * Life expectancy of greater than 12 weeks Exclusion Criteria: * Prior treatment with mitomycin C or nitrosourea compounds * Prior treatment with capecitabine or thalidomide * Clinically apparent central nervous system metastases or carcinomatous meningitis * Peripheral neuropathy of grade 2 or greater severity * Myocardial infarction in the past 6 months * Major surgery in the past 2 weeks * Uncontrolled serious medical or psychiatric illness * Pregnant or lactating women * Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. * Known allergy to 5-FU

Study Objectives This phase I trial is studying the side effects and best dose of bevacizumab and sunitinib in treating patients with solid tumors. 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. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sunitinib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with sunitinib may kill more tumor cells. Conditions: Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: sunitinib malate, BIOLOGICAL: bevacizumab, OTHER: pharmacological study, OTHER: laboratory biomarker analysis 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: * Histologically proven metastatic/unresectable adrenocortical carcinoma or melanoma not amenable to curative surgical or radiation therapy. * Accrual closed as of 5/27/2009 to patients with renal cell carcinoma * No squamous cell histology * No histology in close proximity to a major blood vessel * No history of or known brain metastases, spinal cord compression, or carcinomatous meningitis * No new evidence of brain or leptomeningeal disease on screening CT scan or MRI * ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100% * AST and ALT <= 2.5 times upper limit of normal (ULN) * Bilirubin <= 1.5 times ULN * Creatinine <= 1.5 times ULN * Absolute neutrophil count >= 1,500/mm³ * Platelet count >=100,000/mm³ * Hemoglobin >= 10.0 g/dL * Calcium <= 12.0 mg/dL * Urine protein:creatinine ratio <= 0.5 by urinalysis * Patients with urine protein:creatinine ratio > 0.5 must have proteinuria < 1,000 mg by 24-hour urine collection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for >= 6 months after completion of study therapy * None of the following within the past 12 months: * Myocardial infarction * Severe/unstable angina * Severe peripheral vascular disease (claudication) or procedure on peripheral vasculature * Coronary/peripheral artery bypass graft * New York Heart Association (NYHA) grade III-IV congestive heart failure * Cerebrovascular accident or transient ischemic attack * Clinically significant bleeding * Deep venous thrombosis * Pulmonary embolism * No ongoing cardiac dysrhythmias of NCI CTCAE >= grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval to > 450 msec (males) or > 470 msec (females) * No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation >= 3 beats in a row) * No condition classified as NYHA grade III or IV * No hypertension that cannot be controlled by medications * Blood pressure < 140/90 mm Hg * No evidence of bleeding diathesis or coagulopathy * No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days * No history of or known brain metastases, spinal cord compression or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT or MRI scan unless without progression on * MRI or CT for 3 months." * No significant traumatic injury within the past 28 days * No serious, non-healing wound, ulcer, or bone fracture * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * No known HIV or AIDS-related illness * No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation. * Recovered from prior radiation therapy, surgery, or other prior therapy * No prior bevacizumab or sunitinib malate (SU11248) * Other antiangiogenic therapies allowed * No prior tyrosine kinase inhibitor of the VEGF receptor or bevacizumab for patients with metastatic renal cell carcinoma * No major surgical procedures or open biopsy within the past 28 days * No core biopsy within the past 7 days * No radiation therapy or systemic therapy within the past 4 weeks * No concurrent full-dose anticoagulants (e.g., warfarin) * Concurrent low-dose anticoagulation (e.g., prophylactic port patency) allowed * No concurrent treatment on another clinical trial * No other concurrent investigational drugs * No concurrent major surgery * No other concurrent anticancer agents or therapies, including chemotherapy, biological response modifiers, hormonal therapy, surgery, palliative radiation therapy, or immunotherapy

Study Objectives The purpose of the study is to assessed the efficiency of treatment based on the objective response rate (RECIST 1.1) Conditions: Colorectal Neoplasms Intervention / Treatment: DRUG: Bevacizumab, DRUG: Capecitabine, DRUG: Irinotecan Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Liver metastases of colon cancer or rectal predominant (histological evidence obtained on the primary tumor or liver metastases) * Isolated (no extra-hepatic metastasis, primary tumor resected) * No access to curative hepatectomy (R0 resection foreseeable or not leaving less than 30% residual non-tumor liver normally vascularized), or requiring complex hepatectomy, very large (5 or more segments) and / or risked (class II CPP) * which at least one measurable by RECIST (>2 cm, or >1 cm if Computed tomography (CT) spiraled) * Or extra-hepatic disease of small size potentially accessible to a resection (one or two lung metastases, lymphadenopathy localized accessible to curative resection) * colon or rectal primary tumor : resected or asymptomatic * Progression after first line chemotherapy to treat the metastatic disease, all types of treatment allowed except intra-arterial Bevacizumab * Age >18 years <75 years * Performance status WHO 0 or 1 * Life expectancy >3 months * Bilirubin <1.5 times the upper limit of normal (N), ASAT and ALAT <5N, creatinine <1.5 N neutrophils >1.5 x 10^9/L, platelets >=100 x 10^9/L, hemoglobin >9g/dL. Patients may be included even if they were transfused * CT (or MRI) reference for the measurement of metastases performed within 28 days before the first treatment cycle * Information of the patient or legal representative signing the informed consent * Affiliated to a social security system Exclusion Criteria: * Symptomatic colon or rectal primary tumor (sub-occlusion, significant hemorrhage, major rectal syndrome) * Extra-hepatic metastases other than small size disease potentially accessible after resection * Grade 3-4 allergy to one of the treatment compounds * Two lines of prior chemotherapy. One line is allowed for metastatic disease but must have been started more than 6 months after completion of adjuvant treatment. * Participation during or within 30 days before study to another therapeutic trial with an experimental molecule * Concomitant cancer systemic treatment using immunotherapy, chemotherapy or hormone * Symptomatic CHD or myocardial infarction within 6 months prior entry into the study, cardiac arrhythmia uncontrolled despite treatment * Uncontrolled hypertension (blood pressure >150/100 mm Hg despite hypertensive treatment) * Heart Failure >Grade II of the New York Heart Association (NYHA) (class II-III-IV)severe renal failure * History and / or presence of bleeding disorders and/or thrombotic <6 months * Uncontrolled Serious illness, uncontrolled active infection or other serious underlying condition which may prevent the patient to receive treatment * Pregnancy (or positive pregnancy test at baseline), lactation or no contraception effective for men or women of childbearing age * Occlusion or sub-bowel obstruction or history of inflammatory bowel disease * Other cancer within 5 years prior to entry into the trial or concomitant (except in situ cancer of the cervix or skin basal-cell carcinoma properly treated) * Legal inability (persons deprived of liberty or under guardianship) * Inability to sign the consent or submit to medical test for geographical, social or psychological reasons.

Study Objectives Primary Objective: To evaluate dose limiting toxicity and to determine the recommended phase 2 dose (RP2D) of pentamidine in combination with salvage chemotherapy with ifosfamide, carboplatin and etoposide (ICE) on a 3-weeks schedule in relapsed/refractory classical Hodgkin lymphoma (cHL). Secondary Objective: * To estimate the overall best treatment response at 5- and 16-weeks from study enrollment. Although the clinical benefit of these drugs in combination has not been established, offering this treatment may provide a therapeutic benefit. The patients will be carefully monitored for tumor response and symptom relief, in addition to safety and tolerability. * To estimate the duration of response to the proposed combined therapy. * To measure the protein of regenerating liver-3 (PRL-3) level of expression in patients at time of relapse. * To measure circulating biomarkers of response (soluble CD30 (sCD30), and thymus and activation-related chemokine (TARC)) in serum samples collected throughout treatment and inhibition of (pSTAT, pAKT) in peripheral blood mononucleated cells (PBMC). Exploratory Objective: * To measure cell-free messenger RNA (cfmRNA) in peripheral blood. * To measure cell-free DNA in peripheral blood Conditions: Hodgkin Lymphoma, Refractory Hodgkin Lymphoma Intervention / Treatment: DRUG: Pentamidine 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: * Age 18 years old or older * Eastern Cooperative Oncology Group (ECOG) performance status <=2 * Subjects with histologically confirmed relapse or refractory cHL who had received a front-line anthracycline-containing regimen. * Subjects must have at least one measurable lesion >1.5cm as defined by the lymphoma response criteria. * Subjects must have recovered from their last prior chemotherapy; if they have received an investigational agent, at least 5 half-lives must have expired to assure clearance of prior therapy. * Prior radiation should have been completed at least 4 weeks prior to study Day 1. * Toxicities related to prior therapy must have returned to Grade 1 or less except for alopecia. Peripheral neuropathy must be grade 2 or less. * Adequate bone marrow function defined as: 1) Absolute neutrophil count >= 1000/µl and 2) Platelet count >= 50,000/µl * Adequate organ function: 1) Creatinine Clearance (CrCl) >60 mL/min and 2) Aspartate Aminotransferase (AST) <= 3 upper limit normal (ULN), and Alanine Aminotransferase (ALT) <=3 ULN, and Bilirubin <= 1.5 ULN (Unless they have Gillbert's disease) * Ability to comply with the treatment, evaluations and required study follow-up. Exclusion Criteria: * Subjects with central nervous system involvement. * Subjects with concomitant second malignancy (except adequately treated non-melanoma skin cancer, ductal carcinoma in-situ, superficial bladder cancer, prostate cancer or in situ cervical cancer) are excluded unless a complete remission was achieved at least 3 years prior to study entry and no additional therapy is required or anticipated. * A serious uncontrolled medical disorder or active infection which impairs the ability of the subject to receive protocol therapy or whose control is jeopardized by the complication of this therapy. * Prior organ allograft or allogeneic bone marrow transplantation. * Positive for HIV (1/2) or known acquired immunodeficiency syndrome. * Positive for hepatitis B Surface Ag, or antibody to hepatitis B core ag, or hepatitis C antibody or hepatitis C RNA in serum. * Ejection fraction less than 45% in subjects with prior anthracycline therapy (measurement of ejection fraction is mandatory). * Corrected QT interval (QTc) prolongation of more than 500. * Women of reproductive age who are unwilling or unable to use an acceptable method to minimize the risk of pregnancy for the entire study period and for at least 18 weeks after the last dose of pentamidine. * Women who are pregnant or breast-feeding. * Women with a positive pregnancy test (serum assay) on enrollment or prior to pentamidine administration. * Sexually active men not using birth control if their partners are women of reproductive age. * Prisoner or subjects who are involuntarily incarcerated. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to pentamidine and/or ifosfamide, carboplatin and etoposide. * No investigational or commercial agents or therapies other than those specified by the protocol may be administered with the intent to treat the patient's malignancy.

Study Objectives The purpose of this pilot study is to determine whether Maraviroc is effective in the treatment of Kaposi's Sarcoma (KS), when it does not remit with standard antiretroviral drug therapy. Conditions: Kaposi's Sarcoma Intervention / Treatment: DRUG: Maraviroc 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: * HIV-1 infected, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test. * Active biopsy confirmed KS * Screening plasma HIV RNA < 75 copies/mL * Patients have unremitting KS. Unremitting is defined as having active biopsy confirmed KS in spite of having had sustained HIV RNA < 75 copies/mL for 24 prior months. Isolated values that are detectable but < 500 copies will be allowed as long as the plasma HIV RNA levels before and after this time point are undetectable. * >90% adherence to therapy within the preceding 30 days, as determined by self-report. * Both male and female subjects are eligible. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period. * Ability and willingness of subject or legal guardian/representative to provide informed consent Exclusion Criteria: * Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason. * Serious illness requiring hospitalization or parental antibiotics within preceding 3 months. * Concurrent treatment with immunomodulatory drugs or therapies, or exposure to any immunomodulatory drug or therapy in past 16 weeks. * Prior exposure to CCR5 inhibitors * Screening absolute neutrophil count <1,000 cells/mm3, platelet count <50,000 cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <40 mL/minute. * Elevated transaminases greater than 2.5 times the upper limit of normal. * Evidence of cirrhosis * Pregnant or breastfeeding women * Use of both Tenofovir and Didanosine in current antiretroviral therapy regimen. * Local therapy for any KS index lesion in preceding 60 days, unless lesion has clearly progressed with enlargement since the local therapy

Study Objectives Acute Myeloid Leukemia (AML) is a diverse disease that is fatal in the majority of patients. Acute promyelocytic leukemia (APL) however, a subtype of AML accounting for 5% of all cases, is very curable. APL cells are highly sensitive to the retinoid all-trans-retinoic acid (ATRA), which effectively differentiates the leukemic clone. Over 80% of APL patients can be cured with ATRA based therapies. For patients with non-APL AML, ATRA has little effect. Consequently, 85% of these patients will succumb to their disease despite conventional approaches. Little is known about mechanisms of resistance to ATRA in non-APL AML. This knowledge gap limits the use of ATRA in a disease that already has few effective therapies. The investigators' preliminary data suggest that non-APL AML cells can be re-sensitized to ATRA when combined with lysine-specific demethylase 1 (LSD 1) inhibitors. The investigators' publication in Nature Medicine showed that LSD1 inhibition with tranylcypromine (TCP), unlocked the ATRA-driven therapeutic response in non-APL AML. Notably, treatment with ATRA and TCP markedly diminished the engraftment of primary human AML cells in murine models, indicating that the combination may target leukemia-initiating cells (LIC). The investigators' data identify LSD1 as a therapeutic target and strongly suggest that it may contribute to ATRA resistance in non-APL AML. The investigators' central hypothesis is that ATRA combined with TCP will be safe and effective in a clinical population, and that this approach will suppress LICs and restore myeloid differentiation programs in patients with non-APL AML. Testing this hypothesis with the phase I clinical trial outlined in this protocol, will establish a new treatment paradigm in AML and extend the important anti-cancer effects of ATRA to all AML subtypes. Conditions: Acute Myelogenous Leukemia, Myelodysplastic Syndromes, Leukemia Intervention / Treatment: DRUG: Tranylcypromine, DRUG: Tretinoin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Confirmed diagnosis of one of the following: * Relapsed/refractory Acute Myelogenous Leukemia (AML) as defined by the World Health Organization (WHO) criteria [therapy-related AML and/or secondary AML from an antecedent hematologic disorder not excluded]. * Relapsed/refractory Myelodysplasic Syndrome (MDS) as defined by the World Health Organization (WHO) criteria. * Adult patients 18 years of age or older. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2. * Adequate organ function as defined as: * Total bilirubin <= 1.5 x upper limited of normal (ULN) * ALT and AST must be <= 3 × ULN * Creatinine <= 1.5 x ULN or calculated creatinine clearance > 50ml/min or * PT and aPTT <= 1.5 × ULN * Patients with total bilirubin, Alanine transaminase (ALT), Aspartate transaminase (AST), Creatinine, prothrombin time (PT), and activated partial thromboplastin time (aPTT) levels outside the permitted range are eligible if, in the judgment of the Principal Investigator, the levels are related to the patient's AML or MDS. * Suitable venous access to allow for all study related blood sampling (safety and research). * Estimated life expectancy, in the judgment of the Investigator, which will permit receipt of at least 6 weeks of treatment. * Able to understand and willing to signed the written informed consent and HIPAA document/s. Exclusion Criteria: * Therapy with moderate or strong CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to Cycle1 Day1. * Therapy with Monoamine Oxidase Inhibitors (MAOIs), dibenzazepine derivatives, sympathomimetics, or Selective Serotonin Reuptake Inhibitors (SSRIs) within 14 days prior to Cycle1 Day1. (Patients actively receiving a safe substitute in the judgment of the Principal Investigator are eligible and may continue to receive the safe substitute during protocol treatment) * Therapy with any investigational products, antineoplastic therapy, or radiotherapy within 14 days prior to Cycle1 Day1. Patients actively receiving hydroxyurea are eligible and may continue to receive hydroxyurea during protocol treatment. * Candidates for standard and/or potentially curative treatments. (Candidate defined as a patient that is both eligible and willing) * Major surgery within 28 days prior to Cycle1 Day1. * Grade 2 or higher diarrhea as defined by NCI CTCAE Version 4.03 despite optimal antidiarrheal supportive care within 7 days prior to Cycle1, Day1. * Myocardial infarction within 6 months (24 weeks) prior to Cycle1, Day1. * Class III or IV heart failure as defined by the New York Heart Association (NYHA), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. (Any ECG abnormality at screening has to be documented by the investigator as not medically relevant and confirmed by the Principal Investigator) * Active and uncontrolled infection. * Known human immunodeficiency virus (HIV) positive. * Known hepatitis B surface antigen-positive. * Known or suspected active hepatitis C infections (Patients who are hepatitis C surface antigen-positive are eligible). * Female patients who are pregnant women or breast feeding. Confirmation that the patient is not pregnant will require a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women. * Females of child bearing potential who refused to either practice 2 effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 30 days after the last dose of study drug. * Males of child bearing potential who refuse to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (includes males surgically sterilized - i.e. status post vasectomy). * Serious medical or psychiatric illness/condition likely in the judgment of the Investigator to interfere with compliance to protocol treatment/research. * Known history of allergic reaction to TCP or ATRA. * Symptomatic central nervous system (CNS) involvement. * A concurrent second active and non-stable malignancy (Patients with a concurrent second active but stable malignancy are eligible). * Patients with proliferative AML will be excluded defined by a white blood cell count (WBC) > 5 x ULN UNLESS, the white count has been suppressed to < 5 x ULN with hydroxurea and has remained below this level for at least 2 weeks prior to enrollment on study.

Study Objectives In this study the effect of substituting clemastine IV to cetirizine PO on the occurence of hypersensitivity reactions during paclitaxel chemotherapy will be investigated. Conditions: Solid Tumor Intervention / Treatment: DRUG: Cetirizine Location: Netherlands Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Age >= 18 years; * Planned treatment with regular paclitaxel-based chemotherapy for any indication and with any dose Exclusion Criteria: * Prior treatment with a paclitaxel-based regimen; * Inability to orally ingest cetirizine

Study Objectives To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing Escherichia coli and Klebsiella pneumoniae in hematology and oncology units Conditions: Gram-Positive Bacterial Infections, Escherichia Coli Infections, Klebsiella Infections Intervention / Treatment: DRUG: piperacillin-tazobactam Location: Korea, Republic of Study Design and Phases Study Type: OBSERVATIONAL

Inclusion Criteria: * Eligible patients of either sex, 15 years of age or older * Patients who are admitted to the department of hematology and oncology * Provide written informed consent Exclusion Criteria: * Patients who have hypersensitivity to β-lactam antibiotics * Female who are pregnant or breast-feeding * Any underlying conditions or non-infectious diseases that will be ultimately fatal within 30 days

Study Objectives Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors. Conditions: Solid Tumors Intervention / Treatment: DRUG: BIIB022 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: * Age >= 18 years at the time of informed consent * Relapsed or refractory solid tumors following standard therapy. * ECOG Performance Status 0 or 1. Exclusion Criteria: * History of insulin-dependent diabetes, type 2 diabetes, or hemoglobin A1c >6% at screening. * History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure. * Known central nervous system or brain metastases. * Prior anti-IGF-1R therapy of any kind. Other protocol-defined inclusion/exclusion criteria may apply.

Study Objectives This is a Phase 1, single-site, interventional clinical trial evaluating the safety and efficacy of IS-002 intravenous (IV) injection for fluorescent identification and delineation of the positive cancer margins and metastatic lymph nodes during prostatectomy surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging. Conditions: Prostate Cancer Intervention / Treatment: DRUG: IS-002 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NA Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Subject is between the ages of 18 and 75. * Subject has a confirmed adenocarcinoma by histology of the prostate. * Subject has CAPRA > 6, or T3 a or b disease on imaging (TRUS and/or MRI), or regional lymphadenopathy suspicious for nodal metastases * Subject is scheduled to undergo robotic prostatectomy with extended pelvic lymph node dissection (ePLND) using an da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging. * Subject is willing and able to provide informed consent * Subject is considered capable of complying with study procedures and of understanding a written informed consent document. * Subject must be treatment naïve (not having received neo-adjuvant therapy, radiation therapy, hormonal therapy, androgen deprivation therapy within the last 4 months excluding Finasteride, Dutasteride, or other 5 alpha reductase inhibitors, or focal ablation techniques) Exclusion Criteria: * Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection * Subject is currently participating in and receiving study therapy or has participated in a study of an investigational agent within the past 6 months; is receiving study therapy or is involved in a significant risk investigational device study within the past 6 months * Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile * Subject has a known history of bone metastasis documented on the basis of bone scans and/or biopsy * Subject has a known history of acute or chronic liver or kidney disease

Study Objectives This study will assess the efficacy of AUY922, when administered weekly at 70 mg/m2, in adult patients with advanced Non-small-cell Lung Cancer (NSCLC), who have received at least two prior lines of chemotherapy. Patients will be retrospectively, and prospectively, stratified based on their molecular tumor etiology. The following strata was assigned: Patients with Epidermal growth factor receptor (EGFR) activating mutations, Patients with Kirstin Raus sarcoma virus (KRAS) activating mutations, Patients with EML4-ALK (anaplastic lymphoma kinase) translocations and patients that were both EGFR and Kras wild type. Conditions: Non-small-cell Lung Cancer Intervention / Treatment: DRUG: AUY922 Location: Norway, Germany, Canada, Korea, Republic of, Turkey, Netherlands, Spain, United States, Singapore, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histologically or cytologically confirmed advanced (stage IIIB or stage IV) NSCLC who have received at least two prior lines of treatment. Patients who, in the investigators opinion, are deemed unsuitable for the standard 2nd line chemotherapy will be eligible for protocol participation. One of the prior lines must have included a platinum agent. Prior treatment with a platinum agent is not a requirement for EGFR mutant patients and patients with EML4-ALK translocations * Patients enrolled to the fifth stratum, modified EGFR mutant, must have documented prior response to EGFR TKI as defined by CR, PR or SD for 6 months or greater unless patient has de novo resistance to EGFR TKI (e.g. exon 20 insertions.) * All patients must have at least one measurable lesion as defined by RECIST criteria. Previously irradiated lesions are not measurable unless the lesion is new or has demonstrated clear progression after radiation * World Health Organization (WHO) performance status <= 2. For patients enrolled to the fifth stratum, modified EGFR mutant, World Health Organization (WHO) performance status <= 1 * Patients enrolled to the fifth stratum, modified EGFR mutant, must be willing and suitable to undergo fresh baseline biopsy prior to study treatment (unless patient had recent biopsy after EGFR TKI progression that concluded resistance to EGFR TKI.) * Hematologic: * Absolute Neutrophil Count (ANC) >= 1.5 x 109/L. * Hemoglobin (Hgb) >= 9 g/dl. * Platelets (plt) >= 100 x 109/L. Biochemistry: * Total calcium (corrected for serum albumin) within normal limits or correctable with supplements. * Magnesium within lower normal limits or correctable with supplements. Adequate liver function defined as: * AST/SGOT and ALT/SGPT <= 3.0 x Upper limit of Normal (ULN) or <= 5.0 x ULN if liver metastasis are present. * Serum bilirubin <= 1.5 x ULN. * Serum albumin > 2.5 g/dL. * Serum creatinine <= 1.5 x ULN or 24 hour clearance >= 50 mL/min. Exclusion Criteria: * Patients who have received more than four lines of prior treatment. Exception: Patients enrolled to the fifth stratum, modified EGFR mutant, must not have received more than two prior lines of therapy. Chemotherapy administered as adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study. * Patients with a history of CNS metastasis. Note: Patients without clinical signs and symptoms of CNS involvement are not required to have MRI of the brain. Exception: Patients with treated brain metastases who are asymptomatic, who has discontinued corticosteroids, and who have been clinically stable for one month will be eligible for protocol participation. This exception is not valid for patients enrolled to the fifth stratum, modified EGFR mutant. These patients must not have CNS involvement. * Prior anti-neoplastic treatment with any HSP90 or HDAC inhibitor compound. * Patients must not have received: * any systemic anti-cancer treatment or radiotherapy within 4 weeks prior to first dose of study treatment and should have recovered to baseline or less than Grade 1 from toxicities of such therapy prior to the first dose of study treatment * 2 weeks for palliative radiotherapy to bones, 6 weeks for nitrosoureas and mitomycin * 4 weeks for monoclonal antibodies * and <=5 half-life of the agent or active metabolites [if any] for continuous systemic anti-cancer treatment or investigational * Patients who do not have either an archival tumor sample available or are unwilling to have a fresh tumor sample collected at baseline. Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of eflornithine may be an effective way to prevent the recurrence of or further development of cervical cancer. PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in preventing cervical cancer in patients who have cervical intraepithelial neoplasia. Conditions: Cervical Cancer, Precancerous Condition Intervention / Treatment: DRUG: Eflornithine, OTHER: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: TRIPLE

Inclusion Criteria: 1) Women with newly diagnosed or recurrent CIN grade 2-3, involving an area 3times larger than the biopsy site. Patients must be > 18 years old, with a performance status less than or equal to 2 (Zubrod Scale) and a predicted life expectancy of greater than or equal to 12 months. Patients must have a medically safe form of contraception for the duration of the study. All patients must complete the of pretreatment evaluation, consent to colposcopy and cervical biopsy for histologic evaluation Exclusion Criteria: 1) Patients may not have had a prior malignancy.

Study Objectives Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus \[Types 6, 11, 16, 18\] Recombinant Vaccine), when administered concomitantly with a combined diphtheria, tetanus, pertussis, and poliomyelitis vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines. Conditions: Neoplasms, Glandular and Epithelial, Diphtheria, Tetanus, Whooping Cough, Poliomyelitis Intervention / Treatment: BIOLOGICAL: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF), BIOLOGICAL: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF), BIOLOGICAL: Comparator: REPEVAX™ (Concomitant), BIOLOGICAL: Comparator: REPEVAX™ (Non-Concomitant) Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Must be healthy boys or girls, 11-17 years of age * Must be a virgin with no intention of becoming sexually active during the study period * Must have been properly vaccinated against diphtheria, tetanus, pertussis and polio Exclusion Criteria: * Must not have received a vaccine against diphtheria, tetanus, pertussis and polio in the past 5 years * Must not have received any prior human papillomavirus (HPV) vaccine

Study Objectives The goal of this clinical research study is to learn if it is possible to collect stem cells after ofatumumab and chemotherapy treatment. This study will also evaluate side-effects, number of stem cells collected, and the number of procedures that are needed to collect enough stem cells. Conditions: Lymphoma Intervention / Treatment: DRUG: Ofatumumab, DRUG: Ifosfamide, DRUG: Etoposide, DRUG: Mesna, DRUG: G-CSF, PROCEDURE: Stem Cell Collection 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 confirmed CD20 positive B-cell NHL who are candidates for autologous SCT. * Patients must have PR to salvage chemotherapy. * Age 18-70 years. * Platelet count >= 100,00 mm³ independent of transfusion support. * Absolute neutrophil count >= 1500/mm³. * Zubrod performance status (PS) 2 or less. * Negative serum pregnancy test in women of childbearing potential. This is a female who has not been postmenopausal for at least 12 consecutive months or who has not undergone previous surgical sterilization. * Less than 5% marrow involvement with NHL within 4 weeks of study as defined by unilateral bone marrow aspiration and biopsy. * Seronegativity for HIV, HTLV1, Hepatitis . Exclusion Criteria: * Subjects who have current active hepatic ( (HbsAg, HbcAb, and positive viral load by PCR) or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) with ALT > 2x upper limit of normal or bilirubin > 1.5. (Consult with a physician experienced in care and management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive.) * Active CNS disease. * Severe concomitant medical or psychiatric illness. * Lactating or breast feeding females. * Serum creatinine >1.6 mg/dl. * History of pelvic radiation. * Fludarabine-based chemotherapy within 6 months.

Study Objectives A multicentre, 2-part study to assess the safety and tolerability of once daily oral doses of AZD2171 when administered with various anticancer regimens (part A) and to confirm the tolerability of its combination with FOLFOX (part B). Conditions: Advanced Solid Tumor Intervention / Treatment: DRUG: AZD2171, DRUG: FOLFOX, DRUG: Pemetrexed, DRUG: Irinotecan (administered with & without Cetuximab), DRUG: Docetaxel 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 metastatic cancer that is not amenable to surgery or radiation therapy with curative intent * measurable lesion by CT or other techniques according to RECIST Exclusion Criteria: * Inadequate bone marrow reserve * history of poorly controlled hypertension