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Study Objectives This is an open-label, multicenter, Phase 1/2 study of the CTLA-4 antibody, tremelimumab, and the PD-L1 antibody, durvalumab (MEDI4736), in combination with the tumor microenvironment (TME) modulator poly-ICLC, a TLR3 agonist, in subjects with advanced, measurable, biopsy-accessible cancers. Conditions: Head and Neck Squamous Cell Carcinoma, Breast Cancer, Sarcoma, Merkel Cell Carcinoma, Cutaneous T-Cell Lymphoma, Melanoma, Renal Cancer, Bladder Cancer, Prostate Cancer, Testicular Cancer, Solid Tumor Intervention / Treatment: DRUG: Durvalumab, DRUG: Tremelimumab, DRUG: Poly-ICLC Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: 1. Subjects must have histologic confirmation of advanced, biopsy-accessible, measurable cancers of the following histologies: * Non-viral-associated head and neck squamous cell carcinoma (HNSCC) or human papillomavirus (HPV)-associated HNSCC after failure of prior therapy * Locally recurrent or metastatic breast cancer * Sarcoma * Merkel Cell Carcinoma (MCC) * Cutaneous T cell Lymphoma (CTCL) * Melanoma after failure of available therapies * Genitourinary (GU) cancers with accessible metastases (e.g., bladder, renal) * Any solid tumors with masses that are accessible 2. Subjects with measurable disease, must have at least 2 lesions (1 measurable lesion and 1 biopsy/injectable lesion, which does not need to be measurable). 3. Any number of prior systemic therapies. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 5. Laboratory parameters for vital functions should be in the normal range or not clinically significant. Exclusion Criteria: 1. Prior treatment with combination CTLA-4 and PD-1/PD-L1 blockade, with the exception of subjects with melanoma. 2. Participants may not have been treated intratumorally with poly-ICLC. 3. Subjects with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any active brain metastases, or, within 6 months of the first date of treatment on this study, history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage. 4. Active, suspected or prior documented autoimmune disease, clinically significant cardiovascular disease or clinically uncontrolled hypertension. 5. History of pneumonitis or interstitial lung disease or any unresolved immune-related adverse events following prior biological therapy. 6. Other malignancy within 2 years prior to entry into the study, except for those treated with surgical therapy only (e.g., localized low-grade cervical or prostate cancers). 7. Subjects with clinical symptoms or signs of gastrointestinal obstruction and/or who require drainage gastrostomy tube and/or parenteral hydration or nutrition. 8. Known immunodeficiency or HIV, Hepatitis B, or Hepatitis C positivity. Antibody to Hepatitis B or C without evidence of active infection may be allowed. 9. History of severe allergic reactions to any unknown allergens or any components of the study drugs. 10. Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders). 11. History of allogeneic organ transplant.

Study Objectives The investigators are prospectively validating a prognostic clinical tool that uses a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin to predict survival, post-treatment morbidity, and functional outcomes in patients with metastatic disease involving the spine. Conditions: Spinal Metastases Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: 1. ≥ 18 years of age 2. Confirmed diagnosis of cancer with metastatic spread to the mobile spine or sacrum 3. Able to consent for themselves at the time of the intake evaluation 4. Speaks English Exclusion Criteria: 5. Primary bone tumors or leukemia 6. Metastases to other visceral or skeletal locations, without involvement of the spine or sacrum 7. History of prior spine surgery for metastatic disease

Study Objectives This study is aimed to determine the maximum tolerated dose of ensartinib, an oral ALK inhibitor in Chinese patients with ALK-positive non-small cell lung cancer Conditions: Solid Tumor, Non-Small Cell Lung Cancer Metastatic Intervention / Treatment: DRUG: Ensartinib Location: China 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 confirmed diagnosis of advanced solid tumor malignancy * For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations positive by FISH or IHC * Eastern Cooperative Group ECOG) Performance Status score of 0 or 1 * Adequate organ system function * Male patients willing to use adequate contraceptive measures; female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures * Measurable disease per RECIST * Willingness and ability to comply with the trial and follow-up procedures * Written informed consents are required to indicate that the patients are aware of the investigational nature of the study Exclusion Criteria: * Current use of anticancer therapy. * Use of an investigational drug within 14 days or 5 half-lives (whichever is shorter) prior to the first dose of ensartinib * Any major surgery, radiotherapy, or immunotherapy within the last 21 days. * Chemotherapy regimens with delayed toxicity within the last 4 weeks. * Chemotherapy regimens given continuously or on a weekly basis with limited potential for delayed toxicity within the last 2 weeks. * Prior stem cell transplant * Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically related to ensartinib or to the active ingredient of ensartinib * Prior use of ALK TKIs with the exception of crizotinib * Primary CNS tumors or meningeal metastasis * Pregnant or breastfeeding female * Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of ensartinib * Clinically significant cardiovascular disease. * Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol * Concurrent condition evaluated by investigator would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled * Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol

Study Objectives RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have metastatic bladder cancer. Conditions: Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter Intervention / Treatment: DRUG: oxaliplatin Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic urothelial carcinoma Bidimensionally measurable disease Platinum sensitive OR platinum resistant Platinum sensitive disease: No prior platinum containing regimen OR Progressive or recurrent disease more than 6 months after responding to a platinum containing regimen Platinum resistant disease: Progressive or recurrent disease within 6 months of a platinum containing regimen (cisplatin or carboplatin) No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 30 mL/min Cardiovascular: No uncontrolled concurrent illness including, but not limited to: Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Other: No clinical evidence of neuropathy worse than grade 1 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No allergy to platinum compounds or antiemetics No uncontrolled concurrent illness including, but not limited to, an active infection PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors during the first course of study therapy Chemotherapy: See Disease Characteristics One prior chemotherapy regimen for metastatic disease allowed Prior neoadjuvant or adjuvant chemotherapy regimen allowed if the interval between this therapy and the first therapy for metastatic disease was at least 6 months At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents No HIV positive patients receiving antiretroviral therapy

Study Objectives Lung cancer is a malignant tumor that has transformed from a single cancer disease into one of the most striking global health problems. Lung cancer has an insidious onset, and most patients are first diagnosed with the middle and advanced stage. Cancer related fatigue is the most common and distressing symptom reported by lung cancer patients. For cancer patients, fatigue has lasting impact on physical, psychological and social functions, interferes with activities and participating in life events, thereby worsening the health-related quality of life. Acceptance and Commitment Therapy (ACT) is the third-wave cognitive behavioral therapy to improve functioning and health-related quality of life by increasing psychological flexibility. The study aims to examine the effectiveness of ACT on fatigue interference and health-related quality of life in patients with advanced lung cancer. Conditions: Lung Cancer, Advanced Cancer Intervention / Treatment: BEHAVIORAL: Acceptance and Commitment Therapy (ACT), OTHER: Usual care Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: 1. aged 18 or over; 2. diagnosed with stage III or stage IV lung cancer by pathological section or cytology; 3. experienced unexplained fatigue syndrome: the score of 3 or more on the Fatigue Symptom Inventory (FSI); and 4. able to provide informed consent and effectively collect data. Exclusion Criteria: 1. diagnosed with cognitive dysfunction or other mental illnesses that may interfere with their completion of treatment; 2. who are with a life expectancy \<3 months, or whose physical conditions are considered ineligible for the present study based on the physician's judgment; and 3. who are receiving or have just completed other lung cancer-related intervention programs within the last six months

Study Objectives It is the hypothesis of this project that the Mesenteric Traction Syndrome (MTS) is a common event during upper gastrointestinal cancer surgery (UGC surgery) and that the induction of the syndrome is an important factor in provoking further peri- and postoperative complications and in worsening the surgical stress response (SSR). The characteristics of MTS is hypotension, tachycardia, and flushing. In order to uncover the role of MTS in cancer surgery and the effects on the oncological patients, the aim of the project is: 1. To characterize MTS in patients undergoing three common forms of UGC surgery using a new objective methodology and by recording biomarkers suspected of playing a role in the pathophysiology of MTS and postoperative complication development. Three different interventions will be examined during this prospective trial: 1. Continuous measurement of microcirculation on the forehead using Laser Speckle Contrast Imaging during surgery. 2. Analyses of plasma samples obtained pre-, intra-, and one day postoperatively. 3. Continuous measurements of haemodynamic variables during surgery. Conditions: Gastrointestinal Neoplasms, Mesenteric Traction Syndrome Intervention / Treatment: OTHER: Blood samples, OTHER: Measurement of microcirculation, OTHER: Head down tilt Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: - patients under going either whipple's procedure, liver resection, or gastric resection. Exclusion Criteria: * Robotic assisted procedures * Lack of informed consent

Study Objectives This proposed study is unique in that patients will not undergo computed tomography (CT) simulation at any point during their treatment course and will instead have same-session magnetic resonance (MR)-only simulation and treatment planning, on-table, using the adaptive radiotherapy (ART) workflow. In this manner, patients requiring urgent treatment could initiate treatment as early as the day of initial radiation oncology consultation. Conditions: Malignancy, Metastasis, Hemoptysis, Gastrointestinal Bleeding, Pelvic Bleeding, Superior Vena Cava Syndrome, Mediastinal Disease Intervention / Treatment: DEVICE: Volumetric MR imaging, RADIATION: Radiation therapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosis of malignancy (biopsy proven or high clinical suspicion with urgent/emergent clinical indications for palliative RT) * Requires delivery of palliative radiation therapy for the treatment of painful metastasis, hemoptysis, gastrointestinal bleeding, pelvic bleeding, or superior vena cava syndrome/bulky mediastinal disease. * At least 18 years of age. * Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: * Pregnant. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry. * Medical contraindication to undergoing MR imaging.

Study Objectives This study is being performed to document the outcomes of subjects using our MaxAn Anterior Cervical Plate and assess them for Adjacent level Disease. All subjects will be followed for 2 years. Conditions: DDD, Deformity, Tumor, Fracture Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Subject is scheduled to undergo a one to three-level primary spinal fusion surgery between the levels of C2-T1 (Cervical 2 to Thoracic 1) using the MaxAn® Anterior Cervical Plate System. * Subject has agreed to participate in this study, sign the informed consent and have agreed to return for the 6, 12 and 24 month follow-up visits. * Subjects or their representative must be willing and able to give informed consent. Exclusion Criteria: * Subject has spinal infection or inflammation at any level. * Subject is morbidly obese, defined as a BMI greater than 40. * Subject has a mental illness, alcoholism or drug abuse. * Subject has a metal sensitivity/foreign body sensitivity. * Subject has inadequate tissue coverage over the operative site. * Subject has an open wound local to the operative area, or rapid joint disease, bone absorption, osteopenia and/or osteoporosis. * Female subjects who are pregnant or plan to become pregnant in the next 24 months or who are lactating. * Subject who does not meet the specific indications for use of the MaxAn® Anterior Cervical Plate System. * Subjects participating in another clinical research study. * Any previous cervical spinal surgery.

Study Objectives The primary objectives are to determine feasibility and the acute toxicity profile of proton therapy with concurrent continuous infusion 5-FU chemotherapy. Secondary objectives are to determine late toxicities and to generate preliminary data on clinical efficacy. Conditions: Gastrointestinal Cancer Intervention / Treatment: RADIATION: Proton therapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with histologic diagnosis of adenocarcinoma of the upper gastrointestinal tract, including patients with any of the following diagnoses and settings who are candidates to receive radiation which concurrent continuous infusion 5-FU chemotherapy: Pancreatic adenocarcinoma (unresected and adjuvant), Duodenal adenocarcinoma (unresected or adjuvant), Cholangiocarcinoma (unresected or adjuvant), Gastric adenocarcinoma (unresected or adjuvant), Gastroesophageal junction adeno carcinoma (adjuvant) * Patient must be \>18 years of age. * Patient must have an ECOG Performance Status of 0-2, and a life expectancy of greater than or equal to 3 months. * Patient must be able to provide informed consent. * Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented. Exclusion Criteria: * Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) * Pregnant women, women planning to become pregnant and women that are nursing. * Patients who experience surgical complications which prevent radiation from starting for 3 months or more.

Study Objectives RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to determine the effectiveness of mafosfamide in treating patients who have progressive or refractory meningeal tumors. Conditions: Brain and Central Nervous System Tumors Intervention / Treatment: DRUG: mafosfamide Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: * Diagnosis of leukemia or lymphoma with meningeal involvement defined as cerebrospinal fluid cell count at least 5/mm\^3 AND evidence of blast cells on cytospin preparation or by cytology OR * Diagnosis of other solid tumor with meningeal involvement defined as presence of tumor cells on cytospin preparation or cytology OR presence of measurable meningeal disease on CT or MRI scan * Meningeal malignancy must be progressive or refractory to conventional therapy * Meningeal malignancies secondary to an underlying solid tumor are allowed at initial diagnosis provided there is no conventional therapy * No concurrent bone marrow relapse in leukemia or lymphoma patients * No clinical evidence of obstructive hydrocephalus or compartmentalization of the cerebrospinal fluid flow as documented by a radioisotope indium In 111 or technetium Te 99-DTPA flow study * Patients demonstrating restored flow after focal radiotherapy are allowed PATIENT CHARACTERISTICS: Age: * Over 3 Performance status: * ECOG 0-2 Life expectancy: * At least 8 weeks Hematopoietic: * Not specified Hepatic: * No clinically significant liver function abnormalities Renal: * No clinically significant renal function abnormalities Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study * No clinically significant metabolic parameter abnormalities (e.g., electrolytes, calcium, and phosphorus) * No significant systemic illness (e.g., infection) PRIOR CONCURRENT THERAPY: Biologic therapy: * Recovered from prior immunotherapy Chemotherapy: * At least 1 week since prior intrathecal chemotherapy (2 weeks for cytarabine (liposomal)) and recovered * Concurrent systemic chemotherapy to control systemic or bulk CNS disease allowed with the following exceptions: * No phase I agent * No agent that significantly penetrates the CNS (e.g., high-dose systemic methotrexate (more than 1 g/m\^2), high-dose cytarabine (more than 2 g/m\^2), IV mercaptopurine, fluorouracil, topotecan, or thiotepa) * No agent known to have serious unpredictable CNS side effects Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * Recovered from prior radiotherapy * At least 8 weeks since prior craniospinal irradiation * Local radiotherapy for symptomatic or bulky CNS disease must be given prior to induction therapy * No concurrent whole brain or craniospinal irradiation * Concurrent partial brain (e.g., base of brain) or limited-field spinal radiotherapy for asymptomatic bulky (radiographically visible) CNS disease allowed * Total CNS radiotherapy dose must not exceed accepted safe tissue tolerances Surgery: * Not specified Other: * At least 1 week since any prior CNS therapy * At least 7 days since prior intrathecal investigational agent * At least 14 days since prior systemic investigational agent * No other concurrent intrathecal or systemic investigational agent * No other concurrent intrathecal or systemic therapy to treat meningeal malignancy * No other concurrent intrathecal therapy or agent that significantly penetrates the blood-brain barrier * No concurrent agent known to have serious unpredictable CNS side effects

Study Objectives The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures. Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured using attached thermistor probes. Following baseline measurements, the study gel is applied, the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored for the next two hours. Each patient will receive multiple doses on different days so that each can serve as his/her own control in interpreting the response. Conditions: Raynaud Disease, Raynaud Disease Secondary to Scleroderma, Raynaud Secondary to Other Autoimmune Disease Intervention / Treatment: DRUG: topical organogel with nitroglycerin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: DOUBLE

Inclusion Criteria: * clinical diagnosis of Raynaud's phenomenon * outpoatients * agree to apply gel as per protocol * willing to discontinue current vasodilator therapy * agree to stop other investigational medication for Raynaud's * negative pregnancy test is fertile females * able to give written informed consent and comply with study requirements Exclusion Criteria: * current use of ay nitrate medication or medications that interact with nitroglycerin * patients with a known allergy to nitroglycerin or topical gel ingredients * patients with a history of migraine headaches * patients with unstable medical problems * patients with cognitive or language difficulties * patients with screening lab values more than 20% outside of normal * patients with open lesions at site of application * women of child-bearing potential who are unwilling to comply with contraceptive requirements.

Study Objectives The purpose of this study is to assess the performance and safety of Biology-Guided Radiotherapy (BgRT) using the RefleXion Medical Radiotherapy System (RMRS) via optimizing F18-Fluorodeoxyglucose (FDG) dosing, assessing the performance of the Positron Emission Tomography (PET) imaging subsystem for BgRT treatment planning and delivery, including its role as an interlock, and validating the dose delivery performance of the end-to-end BgRT workflow. Conditions: Cancer, Tumor, Solid, Cancer, Lung, Cancer, Bone, Metastasis to Lung, Metastasis to Bone Intervention / Treatment: DEVICE: RMRS IDE Device Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: 1. Age greater than 21 years 2. A new or prior diagnosis of biopsy-proven cancer with a solid tumor (non-hematologic, non-lymphoma) 3. At least one active tumor in the bone or lung which is either the primary tumor or metastatic lesion determined either by biopsy or imaging suspicious of active disease 4. Target tumor size ≥2cm and ≤5cm 5. Target lesion in the bone or lung that is discrete and assessed by the investigator to be FDG-avid (i.e. SUVmax≥6 on third-party diagnostic PET/CT performed within 60 days with no intervening oncologic therapies) 6. ECOG Performance Status 0-3 7. Must have completed any other oncologic therapies at least 15 days prior to planned start of study procedures (preferably 30 days) and must have no plans to initiate systemic therapy until after study follow up is complete -OR- must be recorded by physician to have an active candidate lesion that is unresponsive to ongoing systemic therapy. 8. Females of childbearing potential should have negative urine or serum pregnancy test within 14 days prior to initiation of study scans. 9. Demonstrate adequate organ function: determined by ANC, platelets, hemoglobin, with no gross hematuria 10. For Cohort II only: Patient is dispositioned to undergo SBRT to a bone or lung tumor Exclusion Criteria: 1. Clinically significant blood glucose abnormalities that preclude a satisfactory FDG PET/CT scan. 2. Previous history of external radiotherapy where prior radiotherapy fields are anticipated to overlap with the radiotherapy fields required for the present study 3. Diffuse metastatic process (leptomeningeal disease, peritoneal carcinomatosis, diffuse bone marrow involvement, etc.) 4. PET-avid structures not intended for radiation are within 2cm from target on third-party diagnostic PET/CT as assessed by investigator 5. Known allergy to FDG 6. Known psychiatric or substance abuse disorder that would interfere with conduct of the study 7. Pregnant, breast-feeding or expecting to conceive during the study 8. Patient weight exceeding the weight limit outlined per IFU. 9. For Cohort II only: Patients with pacemakers and other implantable devices who are deemed to be at high risk by the treating physician for complications secondary to radiotherapy. 10. For Cohort II only: Patients with bone lesions who are determined to be high risk by the treating physician for pathologic fracture prior to beginning radiotherapy. 11. For Cohort II only: Active inflammatory bowel disease, scleroderma, or other disorder deemed to be a risk factor for excess toxicity in the area of treatment by the treating physician.

Study Objectives The goal of the study is to provide a detailed description of treatments for CRPC (Castrate Resistant Prostate Cancer) patients with bone metastases and the resource utilization and costs associated with that diagnosis and subsequent treatments. Conditions: Prostate Cancer Intervention / Treatment: DRUG: Radium-223 dichloride (Xofigo, BAY88-8223) Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * First diagnosis for bone metastases for members diagnosed with prostate cancer found in the claims data during the identification period * Members age ≥ 55 to 89 years at index * Medicare members with medical and pharmacy coverage; and * Continuously enrolled during the pre- and post-index periods. Exclusion Criteria: * Member with diagnosis of any other cancer (excluding melanoma (ICD-9 172.x) and other metastases (ICD-9 198.x)) before the index date; and * Members age ≥ 89 years of age at index date

Study Objectives The purpose of this study is to test the safety of enzalutamide with or without sorafenib at different doses. Enzalutamide is approved by the Food and Drug Administration (FDA) for the treatment of advanced prostate cancer. Enzalutamide blocks a protein called the androgen receptor. Experiments on liver cancer cells and animal models show that blocking the androgen receptor causes liver cancer to stop growing. Enzalutamide has not been approved to treat liver cancer. The investigators want to see if enzalutamide is safe for patients with liver cancer who have had their tumors grow on sorafenib. The investigators also want to see how safe and effective sorafenib and enzalutamide are for liver cancer patients that have never been treated with sorafenib. This is the first time enzalutamide and sorafenib are being used together. This treatment may not help treat the participant's cancer. Conditions: Hepatocellular Carcinoma Intervention / Treatment: DRUG: Enzalutamide, DRUG: Enzalutamide with Sorafenib 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: * Histologic proof of HCC reviewed and confirmed at per the local standard of care. * Advanced unresectable or metastatic disease * Measurable disease as defined by RECIST version 1.1 * Tissue available for the evaluation of AR by IHC on pretreatment HCC samples. If tissue is not available, a pretreatment biopsy will not be necessary for eligibility * Age ≥ 18 years-old * ECOG performance status ≤ 2 * Child-Pugh category A * Adequate hepatic function defined by: * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5.0 x upper limit of normal (ULN) * Total Bilirubin ≤ 1.5 x ULN * Adequate hematologic function defined by: * Absolute neutrophil count (ANC) ≥ 1200/mm3 (≥ 1.2 x 10\^9/L) * Platelets ≥ 75,000/mm3 (≥ 75 x 10\^9/L) * Hemoglobin ≥ 8 g/dL (≥ 80 g/L) * Adequate renal function defined by: * Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 40 mL/min (using the Cockcroft-Gault equation) * Patients must be on antiviral therapy per the local standard of care if active or occult hepatitis B (HBV) infection. * Patients with active hepatitis C (HCV) may not be antiviral therapy. * Patients with a history of hypertension should be well controlled (BP ≤ 140/90) on a regimen of antihypertensive therapy. * Gastrointestinal disorders in the opinion of the treating physician that would impair absorption. * Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study. * Patients with history of liver transplantation may be eligible for the dose expansion cohorts (Parts 2A and 2B) of this study provided all eligibility criteria are met and provided the subject has not had any episodes of acute rejection or serious opportunistic infection within 3 months from enrollment. * Female subjects of childbearing potential must not be pregnant or lactating at screening. * Participants must be capable of understanding and complying with the protocol requirements and signing informed consent. * Certain immunosuppressive agents such as tacrolimus and sirolimus are prohibited due to drug interaction risk thus liver transplant patients who require these medications for immunosuppression are not eligible. * Patients receiving everolimus at immunosuppressive dosages are eligible since the everolimus doses used are lower than standard anti-neoplastic dosages and this agent does not demonstrate anti-cancer activity in HCC. Everolimus does not interact adversely like other immunosuppressive agents. Exclusion Criteria: * Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma * For patients who will receive enzalutamide monotherapy, failure or intolerance of prior sorafenib is required for enrollment. For patients who will receive combination therapy, prior sorafenib is excluded. * Patients may not have received cytotoxic, biologic or small molecule kinase inhibitor systemic therapy f or at least 3 weeks prior to the first dose of study treatment. * Patients must not have received prior regional therapy such as ablation, embolization, or radiation therapy for at least 2 weeks prior to the first dose of study treatment. Patients who receive such therapy should have evidence of radiologic progression at this site or other progressing measurable disease. * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before study enrollment. Eligible subjects must be without corticosteroid treatment at the time of study enrollment. * History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization). Also, current or prior treatment with antiepileptic medications for the treatment of seizures or history of loss of consciousness or transient ischemic attack within 12 months of enrollment. * Clinically significant cardiovascular disease including: * Myocardial infarction within six months prior to Screening; * Uncontrolled angina within three months prior to Screening; * Congestive heart failure NYHA class 3 or 4, or subjects with history of congestive heart * failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or MUGA scan * performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%; * History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes); * History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place; * Anticoagulation with warfarin * Inability to swallow tablets * Subjects with history of another primary cancer, with the exception of: * curatively resected non-melanoma skin cancer; * curatively treated cervical carcinoma in situ; * other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC. * Patients who are on strong inhibitors of CYP2C8, strong or moderate inducers of CY3A4 and CYP2C8 should discontinue these medications 2 weeks prior to the start of treatment

Study Objectives Heart rate variability biofeedback (HRV-B) is a complementary, non-pharmacologic therapy that is being tested to see if it can help cancer survivors reduce their symptoms of pain, stress, insomnia, fatigue, or depression. HRV-B is an interactive procedure in which participants relax and breathe regularly while watching the a computer screen. The computer screen provides feedback that helps people increase their heart rate variability. Conditions: Cancer Intervention / Treatment: BEHAVIORAL: Biofeedback Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * histopathologically confirmed diagnosis of cancer having completed radiation or chemotherapy * 18 years of age or older * English literate Exclusion Criteria: * patients receiving concurrent treatment for cancer except hormonal or biologic therapy * patients with cardiovascular disorders that affect HRV parameters (paroxysmal supraventricular tachycardia, atrial fibrillation, myocardial infarction within 12 months, unstable angina) * patients receiving medications that affect cardiac rhythm (angiotensin converting enzyme, calcium channel, or beta-adrenergic inhibitors) * patients with a pacemaker or defibrillator * patients who have had a heart transplant or by-pass surgery within 1 year * patients with any active seizure disorder or use of antiseizure or anticonvulsant medication prescribed specifically for seizure disorder * patients with a pre-existing dementia prior to cancer diagnosis * patients with a moderate (without good recovery) or severe head injury or stroke in last 6 months * patients with evidence of active substance abuse or dependence * patients with a history of any major psychiatric disorder * patients with a history of brain metastases, primary brain cancer, or altered cognitive abilities * patients with any use of long acting (extended release) opioid medications

Study Objectives This is a Phase I/II study to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics following daily oral doses of 50 to 200 mg of BMS-754807 in combination with trastuzumab (Herceptin®) in subjects with advanced or metastatic Her-2-positive breast cancer. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with trastuzumab for Phase II studies and provide preliminary evidence of anti-tumor activity in Her-2-positive breast cancer subjects after trastuzumab failure Conditions: Breast Cancer Intervention / Treatment: DRUG: BMS-754807, DRUG: trastuzumab (Herceptin®) Location: Belgium, Hungary, Canada, Australia, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

For additional information on this trial, please call (910) 558-2913 Inclusion Criteria: * Subjects with locally advanced or metastatic Her-2-positive breast cancer who have failed at least one trastuzumab containing regimen. Prior treatment with other Her-2-targeted agents (e.g. lapatinib, pertuzumab, trastuzumab DM-1 etc.) is allowed * Histologic or cytologic diagnosis of Her-2-positive breast cancer * ECOG status 0 - 1 Exclusion Criteria: * Symptomatic brain metastasis * Any condition requiring chronic use of steroids * Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms * History of glucose intolerance * Women of child-bearing potential unwilling or unable to use acceptable contraception methods

Study Objectives This behavioral clinical trial assesses the efficacy of a educational intervention to increase shared decision making about prostate-specific antigen (PSA)-based screening for prostate cancer among African American males. Half of participants will receive a multimedia educational intervention, while the other half will receive usual care. Conditions: Prostate Cancer Intervention / Treatment: BEHAVIORAL: Educational Shared Decision-Making Intervention Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Patient Inclusion Criteria: * Receiving care at the clinical sites * Identify as African American male * Ages 40-69 years old Patient Exclusion Criteria: * Personal history of prostate cancer at the time of consent * Cognitive impairment that would interfere with participation in the study * Unable to complete any aspect of the intervention within the specified time limit

Study Objectives RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Phenethyl isothiocyanate may be effective in preventing lung cancer in smokers. PURPOSE: Phase I trial of phenethyl isothiocyanate in preventing lung cancer in people who smoke. Conditions: Lung Cancer Intervention / Treatment: DRUG: phenethyl isothiocyanate Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: PREVENTION Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: Asymptomatic smokers who either refuse to or cannot stop smoking Urinary cotinine levels greater than 100 ng/mL Willing to adhere to certain dietary restrictions limiting intake of cruciferous vegetables (watercress, broccoli, radishes, mustard, brussels sprouts) while on study PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.6 mg/dL Transaminases less than 2 times normal Renal: Creatinine less than 1.6 mg/dL Urinary RBC levels 0-2 Urinary WBC levels at least 0-2 Pulmonary: No dyspnea at rest Other: No concurrent illness, condition, or symptom that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Not specified

Study Objectives RATIONALE: Computer-assisted stop-smoking plans and telephone counseling may help people stop smoking. It is not yet known which computer-based smoking cessation program is more effective with or without telephone counseling in helping smokers quit smoking. PURPOSE: This randomized clinical trial is studying two different computer-based smoking cessation programs to compare how well they work with or without telephone counseling in helping smokers quit smoking. Conditions: Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: BEHAVIORAL: Basic Internet, BEHAVIORAL: Enhanced Internet, BEHAVIORAL: Enhanced Internet + phone Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: SINGLE

DISEASE CHARACTERISTICS: * Smokes at least 5 cigarettes a day * No prior use of QuitNet website * Must have access to the internet and a telephone at home or work PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Study Objectives This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA) (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys\[Ahx\]) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying prostate cancer that may have returned after a period of improvement (biochemical recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer receptor, which can then be imaged by the PET/CT or PET/MRI scanner. Conditions: Recurrent Prostate Carcinoma Intervention / Treatment: PROCEDURE: Computed Tomography, DRUG: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx), PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Provides written informed consent * Known diagnosis of prostate cancer * Patient has suspected recurrence based on biochemical data (prostate specific antigen \[PSA\] \> 2 ng/mL) * Able to remain still for duration of each imaging procedure (about one hour) Exclusion Criteria: * Unable to provide informed consent * Inability to lie still for the entire imaging time * Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

Study Objectives RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from the toxic effects of chemotherapy. PURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system toxic effects in patients given an accidental overdose of intrathecal methotrexate. Conditions: Neurotoxicity, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: glucarpidase Location: Canada, Australia, United States, Switzerland Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: Interventional Model: Masking: NONE

DISEASE CHARACTERISTICS: * Patients who received an intrathecal overdose of methotrexate of 100 mg or more PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No prior anaphylactic reaction to carboxypeptidase-G2 administration PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * Concurrent therapy allowed

Study Objectives The purpose of the study is to determine if outcome for patients with mantle cell lymphoma is improved by adding radioimmunotherapy to high-dose regimen before auto-transplant in patients who are not in CR after induction therapy. Conditions: Mantle Cell Lymphoma Intervention / Treatment: DRUG: 90Y-ibritumomab tiuxetan (Zevalin) Location: Norway Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion criteria: 1. Age 18 - 65 years. 2. Histologically confirmed (according to the WHO classification) mantle cell lymphoma stage II-IV at time point of diagnosis. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin-D1 and most cases will have t(11;14) translocation. 3. No previous treatment for lymphoma except radiotherapy or one cycle of any regimen and except patients treated in the previous phase II study who can be transferred to NLG-MCL-III before evaluation at week 15. 4. WHO performance status of 0 - 3. 5. Life expectancy of more than 3 months. 6. Written informed consent. Exclusion Criteria: 1. Severe cardiac disease: cardiac function grade 3-4 (Appendix 1). 2. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment. 3. Pregnancy/lactation 4. Men or woman of reproductive potential not agreeing to use acceptable method of birth control during treatment and for six moths after completion of treatment. 5. Known HIV positivity 6. Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma. 7. Known seropositivity for HCV, HbsAg or other active infection uncontrolled by treatment. 8. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.

Study Objectives This will be a prospective randomized controlled trial comparing CO2 insufflation and WE in terms of right colon combined adenoma miss rate (AMR) and hyperplastic polyp miss rate (HPMR) by tandem inspection. It will be a single-site study conducted in Taiwan. Conditions: Right Colon Adenoma Miss Rate, Right Colon Hyperplastic Polyp Miss Rate Intervention / Treatment: PROCEDURE: Colon polypectomy Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Consecutive patients aged 45 years or older undergoing colonoscopy for screening, surveillance, and positive FIT will be considered for enrollment. Exclusion Criteria: * familial adenomatous polyposis and hereditary non-polyposis CRC syndrome, personal history of CRC or inflammatory bowel disease, previous colonic resection, obstructive lesions of the colon, gastrointestinal bleeding, allergy to fentanyl, midazolam or propofol, American Society of Anesthesiology (ASA) classification of physical status grade 3 or higher, mental retardation, pregnancy, and refusal to provide a written informed consent.

Study Objectives Mesenchymal stem cells (MSCs) have been used in the treatment and prevention of graft-versus host disease (GVHD). In this study the investigators aim to present the efficacy of mesenchymal stem cells in graft versus host disease prophylaxis and effect of engraftment in haploidentical recipients. Forty patients aged older than 18 who have indications for haploidentical hematopoietic stem cell transplantation will be included to the study. MSCs will be isolated from donor bone marrows and infused to the patient after conditioning regimen on day +6. If the haploidentical transplantation results improve with MSCs treatment it would be possible to ameliorate the problem of HLA-matched donor paucity in Turkey and prefer haploidentical donors. Conditions: Hematopoietic Stem Cell Transplantation Intervention / Treatment: BIOLOGICAL: mesenchymal stem cells, DRUG: cyclophosphamide administration Location: Turkey Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosed with haematological malignancy * Indication of haploidentical hematopoietic stem cell transplantation * No restrictions for transplantation Exclusion Criteria: * Any restriction for transplantation * No indication of haploidentical hematopoietic stem cell transplantation

Study Objectives This study, sponsored by NCI and the Gynecologic Oncology Group (GOG), will collect tissue samples from women with cancer of the endometrium (lining of the uterus). Researchers will use the samples to learn more about endometrial cancer and develop new treatments and methods of prevention. Women with endometrial cancer who are suitable candidates for surgery and who have not had prior retroperitoneal surgery or pelvic or abdominal radiation therapy may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, and endometrial biopsy (surgical removal of a small tissue sample) or dilation and curettage (D \& C). Participants will undergo hysterectomy (surgery to remove the uterus) along with removal of both fallopian tubes and ovaries. This is the standard surgical treatment for endometrial cancer. Lymph nodes in the pelvis near the main blood vessel in the abdomen are also removed to determine if the disease has spread to these nodes. If cancer is found involving other sites, the cancer in those areas may also be removed; examination of the tissues will determine if further therapy beyond surgery is needed. Before surgery, patients will complete a 20-minute questionnaire that includes questions about their background, reproductive history, menstruation and menopause, certain surgeries, birth control pills and hormone replacement therapy, other drugs and medicines, weight and height, smoking, medical history, and family history of cancer. Some of the tissue removed during surgery, plus a urine sample collected from a catheter bag during surgery, and blood drawn before surgery and at follow-up visits 6 weeks and 3 years after surgery, will be sent to the GOG Tissue Bank in Columbus, Ohio. This bank stores, processes, and distributes biological specimens from patients that agree to participate in studies conducted by the GOG. Patients will have follow-up visits 6 weeks after surgery, then every 6 months for the next 2 years, followed annually for the next 7 years, for a total 10-year follow-up. The visits will include an examination and questions about health status and treatments received between visits. Patients whose cancer returns or worsens will undergo another tumor biopsy, if possible, at that time. Conditions: Endometrial Cancer Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

* INCLUSION CRITERIA: * Patients with endometrial carcinoma diagnosed by an endometrial biopsy or dilation and curettage who will undergo full surgical staging; all stages, grades and histologic subtypes will be eligible. * Patients must be suitable candidates for surgery. Patients may also be entered on GOG-2222 (LAP2). * Patients who have signed an approved Informed Consent. * Patients who have met the pre-entry requirements specified in the Study Parameters. * Patients with a prior malignancy (at least 5 years since diagnosis) with no current evidence of disease. EXCLUSION CRITERIA: * Patients not considered suitable candidates for surgery. * Patients who have had prior retroperitoneal surgery. * Patients who have received prior pelvic or abdominal radiation therapy. * Patients who are pregnant.

Study Objectives The purpose of this study is to assess the 2-year progression-free survival rate. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Bortezomib, DRUG: Melphalan, DRUG: Prednisone Location: Korea, Republic of Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Participants who are naïve to chemotherapy for multiple myeloma and not eligible for autologous stem cell transplantation * Participants with symptomatic multiple myeloma: a) Intramedullary monoclonal plasma cells greater than or equal to (\>=) 10% or histologically confirmed plasmacytoma; b) Presence of monoclonal protein in the serum or urine; c) Myeloma-related organ impairment as defined in protocol * Participants with presence of an illness that is detectable by definitions as defined in protocol * Postmenopausal, sterilized or sexually inactive women, including women of childbearing potential who exercise effective contraceptive measures before and during the clinical trial Exclusion Criteria: * Participants with previous experience of receiving a therapy for multiple myeloma (excluding radiotherapy and dexamethasone \< 160mg in total) * Participants with severe peripheral neuropathy (Grade \>= 2 by NCI CTC version 4.0) * Pregnant or breastfeeding mothers * Participants with mental illness that can interfere with his/her cooperation with the therapy or the monitoring conditions of the clinical trial * Participants with other serious medical conditions (such as uncontrolled hypertension, diabetes mellitus and active infections)

Study Objectives Screening colonoscopy has been established as the most effective means of colorectal cancer prevention. This is based on the fact that colonoscopy detects and removes colonic polyps (adenomas) which are known to progress to cancer if left untreated. The present study examines the question whether case volume (i.e., the number of colonoscopies performed per year) correlates with colonoscopy quality, i.e., adenoma detection rate. Conditions: Colorectal Cancer Intervention / Treatment: Location: Germany Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * all persons willing and able to undergo screening colonoscopy over the age of 55 years Exclusion Criteria: * any condition not compatible with the definition of screening colonoscopy

Study Objectives To ascertain the possibilities to isolate the breast cancer olfactive signature. Conditions: Breast Cancer, Surgery Intervention / Treatment: DIAGNOSTIC_TEST: Sorbstar®, DIAGNOSTIC_TEST: Odour sampling Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: TRIPLE

Inclusion Criteria: 1. Patient received in surgery consultation for an invasive non metastatic breast cancer treated by breast-conserving surgery with axillary or sentinel node dissection 2. Of-Age female patient (over 18 years old) 3. Life expectancy \> to 1 year at the inclusion 4. Performance status: 0 or 1 or 2 5. Patient benefiting from the social security 6. Signature informed consent of the study Exclusion Criteria: 1. Neoplasia in progress or neoplasia history of cancer other than breast to be treated. 2. Wound presence on breasts 3. Male subjects 4. Specified metastatic breast cancer 5. Concomitant medication taken one month before the surgical act (antibiotics, corticoids, anti-diabetics) 6. Persons under guardianship or deprived of liberty 7. Impossibility to submit to the medical monitoring expected by the study for geographical, social or psychological reasons.

Study Objectives RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. PURPOSE: This randomized phase II trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer. Conditions: Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition, Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: BIOLOGICAL: epoetin alfa Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

DISEASE CHARACTERISTICS: * Histologically confirmed nonmyeloid cancer * No history of myelodysplasia * Baseline hemoglobin 11-12 g/dL * No anemia due to factors other than cancer or chemotherapy (e.g., iron, cyanocobalamin \[vitamin B_12\], or folate deficiencies, hemolysis, or gastrointestinal bleeding) * Receiving chemotherapy that meets the following criteria: * Administered weekly OR every 3 weeks * Must begin chemotherapy on or before the first day of study treatment * No known, untreated CNS metastases PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * At least 6 months Hematopoietic * See Disease Characteristics * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 (transfusion independent) * Iron transferrin saturation \> 20% * No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency) Hepatic * Bilirubin \< 2.0 mg/dL * SGPT ≤ 3 times upper limit of normal Renal * Creatinine ≤ 1.5 mg/dL * No significant, uncontrolled genitourinary disease or dysfunction Cardiovascular * No uncontrolled cardiac arrhythmia in the past 6 months * No uncontrolled hypertension * No deep vein thrombosis, ischemic stroke, or other arterial or venous thrombotic events * Superficial thromboses allowed * No other significant, uncontrolled cardiovascular disease or dysfunction Pulmonary * No significant, uncontrolled pulmonary disease or dysfunction * No pulmonary emboli Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No infection requiring hospitalization or antibiotics in the past 14 days * No known hypersensitivity to mammalian cell-derived products or to human albumin * No new onset (in the past 3 months) poorly controlled seizures * No other active malignancy except basal cell carcinoma or carcinoma in situ * Not an employee of the investigator or study center or family members of the employee or the investigator * No significant, uncontrolled neurological, endocrine, or gastrointestinal disease or dysfunction PRIOR CONCURRENT THERAPY: Biologic therapy * See Chemotherapy * More than 3 months since prior erythropoietic agent (e.g., epoetin alfa, darbepoetin alfa, or gene-activated erythropoietin) * More than 4 weeks since prior packed red blood cell transfusion * No concurrent stem cell harvest of bone marrow * No concurrent interleukin-11 * No other concurrent erythropoietic agent Chemotherapy * See Disease Characteristics * No concurrent high-dose chemotherapy with stem cell transplantation Radiotherapy * No concurrent nonpalliative radiotherapy Surgery * More than 2 weeks since prior major surgery Other * At least 1 month since prior investigational agents or devices * No concurrent high-dose IV iron supplementation

Study Objectives This study will determine whether a new diagnostic test called the Cell Search Assay can detect circulating colon cancer cells in patients who have had surgery for colon cancer and had visible cancer removed. Other parts of the study will look at whether the presence of the circulating tumor cells in blood predicts whether a patient will have their colon cancer return. Conditions: Colon Cancer Intervention / Treatment: PROCEDURE: Cell Search Assay Location: Canada Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * stage II or III colon cancer Exclusion Criteria: * none

Study Objectives * Rationale: The optimal preoperative medical management for patients with a pheochromocytoma is currently unknown. In particular, there is no agreement with respect to whether phenoxybenzamine or doxazosin is the optimal alfa-adrenoreceptor antagonist to be administered before surgical resection of a pheochromocytoma. We hypothesized that the competitive alfa1-antagonist doxazosin is superior to the non-competitive alfa1- and alfa2-antagonist phenoxybenzamine. * Objective: comparing effects of preoperative treatment with either phenoxybenzamine or doxazosin on intraoperative hemodynamic control in patients undergoing surgical resection of a pheochromocytoma. * Study design: Randomised controlled open-label trial. * Study population: 18 - 55 yr old. Adult patients with a recently diagnosed benign pheochromocytoma. * Intervention: Patients are randomised to receive oral treatment with either phenoxybenzamine or doxazosin preoperatively. * Main study parameters/endpoints: The main study parameter is defined as the percentage of intraoperative time that blood pressure is outside the predefined target range after pretreatment with either phenoxybenzamine or doxazosin. In this multicenter trial, we compare the effects of two commonly used drugs in patients being medically prepared for resection of a benign pheochromocytoma. Participants are not subjected to an experimental treatment of any kind, as we merely aim to describe in detail the perioperative course in general and, in particular, the intraoperative hemodynamic control in patients treated preoperatively with either phenoxybenzamine or doxazosin. A routine diagnostic work-up for pheochromocytoma will be performed in all participants. One extra blood sample (volume: 48,5 mL) is drawn before start of the study medication, and participants need to record their symptoms in a diary. In addition, patients who are pretreated in the outpatient clinic monitor their blood pressure and pulse rate at home with an automated device. Treatment with an alfa-adrenoreceptor antagonist is initiated at least 2 - 3 weeks prior to surgery. Patients who are admitted to the hospital for pretreatment with an alfa-adrenoreceptor antagonist have their blood pressure and pulse rate measured by the nursing staff. The final site visit is planned at 30 days after surgery, in line with current practice. Conditions: Pheochromocytoma Intervention / Treatment: DRUG: Phenoxybenzamine, DRUG: Doxazosin Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * age \> 18 years * diagnosis of benign Pheochromocytoma (adrenal or extra-adrenal, sporadic or hereditary: * hypertension * elevated plasma and/or urinary (nor)metanephrines. From each patient, a blood sample is collected for measurement of plasma (nor)metanephrines with the reference laboratory assay (i.e. XLC-MS/MS) at the Department of Laboratory Medicine of the UMCG. * localisation of PCC by anatomical (MRI/CT) and functional imaging (I123-MIBG scintigraphy or 18F-DOPA PET) * planned for surgical removal of the PCC Exclusion Criteria: * age \< 18 years * malignant PCC, i.e. presence of lesions on imaging studies suggestive of distant metastases * severe hemodynamic instability before surgery necessitating admission to intensive care unit * pregnancy * incapability to adhere to the study protocol

Study Objectives This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase inhibitor (TKI) agent. Part A will assess the effect of osimertinib on the pharmacokinetic (PK) parameters of fexofenadine, following single and multiple oral dosing of osimertinib in a fasted state. Continuous Access will allow patients further access to osimertinib after the PK phase (Part A). All patients from Part A who completed treatment may continue to receive osimertinib 80 mg once daily until: they are no longer deriving clinical benefit; or any other reason Conditions: Non Small Cell Lung Cancer Intervention / Treatment: DRUG: Fexofenadine tablet dosing, DRUG: Osimertininb tablet dosing Location: Korea, Republic of, Spain, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female, ≥18 years * Histological or cytological confirmation diagnosis of NSCLC * Radiological documentation of disease progression while receiving previous continuous treatment with an EGFR-TKI. * Confirmation that the tumour harbours an EGFR mutation known to be associated with EGFR-TKI sensitivity * ECOG performance status 0 to 1, with no deterioration over the previous 2 weeks. * Patients must have a life expectancy of 12 weeks or longer * Females should be using adequate contraceptive measures and must have a negative serum pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child bearing potential. * Male patients should be willing to use barrier contraception ie, condoms until 6 months after the last study drug is taken. * For inclusion in optional genetic research, patients must provide separate informed consent. Exclusion Criteria: * Treatment with any of the following: * A 1st or 2nd generation EGFR-TKI within 8 days or approximately 5 half-lives, of the first dose of study treatment * Osimertinib in the present study \[ie, dosing with osimertinib previously initiated in this study\] or has previously received a 3rd generation EGFR-TKI \[eg, CO 1686\]. * Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment. * Major surgery \[excluding placement of vascular access\] within 4 weeks of the first dose of study treatment. * Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment * Patients currently receiving \[or unable to stop at least 3 weeks prior to first dose of osimertinib\] medications or herbal supplements known to be potent inducers of CYP3A4 or inducers/inhibitors of P-gp. * Spinal cord compression or brain metastases, unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment. * Any of the following cardiac criteria: * Mean resting corrected QT interval corrected for heart rate using Fridericia's correction factor \[QTcF\] greater than 470 msec, obtained from 3 ECGs. * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG \[eg, complete left bundle branch block, third degree heart block, second degree heart block, PR interval greater than 250 msec\] * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval * Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease. * Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: * Absolute neutrophil count \[ANC\] less than 1.5 × 109/L * Platelet count less than 100 × 109/L * Haemoglobin less than 90 g/L * ALT greater than 2.5 times ULN if no demonstrable liver metastases or greater than 5 times ULN in the presence of liver metastases * AST greater than 2.5 times ULN if no demonstrable liver metastases or greater than 5 times ULN in the presence of liver metastases * Total bilirubin greater than 1.5 times ULN if no liver metastases or greater than 3 times ULN in the presence of liver metastases * Creatinine greater than 1.5 times institutional ULN concurrent with creatinine clearance less than 50 mL/min \[measured or calculated by Cockcroft-Gault formula\] * Patients unable to swallow orally administered medication or with gastrointestinal disorders or significant gastrointestinal resection likely to interfere with the absorption of the study drugs.

Study Objectives Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery). Patients included have a non resectable, recurrent gynaecologic or digestive pelvic cancer. The aim of the study is to show a 25% increase in 1 year overall survival rate with isolated pelvic perfusion. Conditions: Gynaecologic or Digestive Pelvic Cancer Intervention / Treatment: DRUG: Isolated pelvis perfusion, RADIATION: radiotherapy, PROCEDURE: Surgery Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically proved locally advanced gynaecologic or digestive tumours (epidermoid carcinomas, adenocarcinomas, neuroendocrine tumours, sarcomas or melanomas), (cervix, vagina, rectal, anal). * Locally recurrent tumours for which surgical treatment will be mutilating or marginal (R1 or R2) and/or for cervix cancer, primary tumours non accessible for standard treatment (radiotherapy- chemotherapy - brachytherapy and surgery). * Surgically resectable tumour (R0 type) but for which patient does not agree with surgery. * Patients aged over 18 and under 76 ans * Performance OMS Index ≤ 2 * Normal biologic parameters * Good general and cardiac state (ASA I or II and NYHA I or II) Exclusion Criteria: * Surgically resectable tumour (RO) or peritoneal tumour extension or distant metastasis. * Cardiac or vascular pathology * Pulmonary disease * Uncontrolled Sepsis disease * Pregnancy

Study Objectives RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ. Conditions: Breast Cancer Intervention / Treatment: DRUG: tamoxifen citrate, PROCEDURE: adjuvant therapy, RADIATION: radiation therapy Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

DISEASE CHARACTERISTICS: * Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis * Unicentric * Lesions ≤ 2.5 cm * Low nuclei grade (NG1) or intermediate nuclei grade (NG2) with necrosis in \< one third of the involved ducts * Inked margins ≥ 3 mm * Clinically node negative * Non-palpable * No suspicious areas on post-operative mammogram taken within 12 weeks after final surgery * No bloody nipple discharge * No more than 12 weeks since prior final surgery (arm II only) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 26 and over Sex: * Female Menopausal status: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant or nursing * No active connective tissue disorders (e.g., lupus or scleroderma) * No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * No other concurrent hormonal therapy (e.g., raloxifene, hormone replacement therapy, or birth control pills) Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics

Study Objectives Patients with metastatic renal cell carcinoma (mRCC) who failed first-line therapy with sunitinib or pazopanib was treated with everolimus. Efficacy and safety of everolimus was evaluated in these patients. Conditions: Metastatic Renal Cell Carcinoma (mRCC) Intervention / Treatment: DRUG: Everolimus (RAD001) Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with advanced renal cell carcinoma of a histological or cytological confirmation of clear cell renal carcinoma. * Progression during or after a treatment with sunitinib or pazopanib given in a 1st line treatment situation for mRCC. * Patients scheduled for treatment with everolimus. * Patients with at least one measurable lesion at baseline as per RECIST v1.1. Exclusion Criteria: * Patients who have received \>1 prior systemic treatment for their metastatic RCC. Prior systemic treatment in an adjuvant setting is allowed. * Patients who have previously received systemic mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus). * Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start. * Patients unwilling or unable to comply with the protocol.

Study Objectives In various common cancers, the skeleton is a preferred site of metastasis. These bone metastases are the most common cause of cancer-related pain, which significantly impair quality of life. It is postulated that the clinical target volume (CTV) of painful bone metastases consists of cancer cells and tumor-associated host cells: the tumor-host ecosystem. Advances in biological imaging (positron emitting tomography PET) might allow us to selectively identify the tumor-host ecosystem within the anatomical boundaries of a bone metastasis. These findings suggest the potential of intentionally non-homogenous dose escalation (dose painting by numbers) to improve pain control. The hypothesis is that fluorodeoxyglucose positron emitting tomography (FDG-PET) can detect the intra-bone metastasis regions confined with tumor-associated host-cell compartments responsible for metastasis-related pain. The primary objective is to improve pain control with biological image-guided stereotactic body radiotherapy compared to conventional radiotherapy. Conditions: Bone Metastases Intervention / Treatment: RADIATION: Conventional Radiotherapy, RADIATION: Biological image-guided radiotherapy with conventional dose., RADIATION: Biological image-guided SBRT with dose-escalation. Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2, PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: SINGLE

Inclusion Criteria: * Painful bone metastasis of solid tumors * Pain score minimum of 2 on a scale of 10 * A maximum number of painful bone metastases: 3 or more * Life expectancy \> 3 months * Age minimum 18 years old * Signed informed consent Exclusion Criteria: * Tumor histology (renal cell and melanoma vs. other solid tumors) * VAS pain score (\<5 vs. 6-10). * Bisphosphonate use (yes vs. no) * Opioid analgesics (yes vs. no) * Corticosteroid use (yes vs. no) * Spine vs non-spine localisation

Study Objectives Bevacizumab might influence the dynamic vessel function after being administered intravenously. Conditions: Cancer Intervention / Treatment: DRUG: bevacizumab treatment Location: Germany Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * patients who wish and need bevacizumab treatment for underlying disease Exclusion Criteria: * previous bevacizumab treatment * known eye disease, eye surgery or eye trauma in history * myopia \>-2.0 dpt * hyperopia \> +2.0 dpt. * relevant media opacity of the lens * acute heart disease, ischemic insult, proven coronary heart disease * cardiac arrhythmia or vessel anomalies * seizure disorder or episode in history * migraine * treatment with corticosteroids within 4 weeks before study inclusion * intake of vasoactive drugs like AT-1 or glitazone * pregnancy

Study Objectives The purpose of this study is to collect blood samples and study cancer cells found in these blood samples from patients with pancreatic cancer. Prior research has discovered that tumor cells can be collected from the blood of patients with pancreatic and other cancers. The physicians have developed techniques for isolating and analyzing cancer cells using a simple blood test. They will study how these cells relate to how chemotherapy works. They hope to use this information to guide choices of treatment for patients in the future. Conditions: Pancreatic Adenocarcinoma Intervention / Treatment: OTHER: Blood draw Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC. * Patient eligible for chemotherapy treatment. * Prior surgery, chemotherapy and/or radiation therapy for pancreatic adenocarcinoma is permitted. * ECOG performance status 0-2. * A minimum age of 18 years old. Exclusion Criteria: * Known to be HIV positive on antiretroviral therapy * Prior organ allograft * Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures

Study Objectives This study is a primary investigation to determine the usefulness and safety of a short course of a relatively high dose of letrozole (a medication used to decrease the female hormone estrogen which is produced locally inside the breast after menopause) in improving the performance of of breast MRI (Magnetic Resonance Imaging). The inhibition of estrogen in the breast by letrozole might help better identifying of suspicious areas in the breast and could assist radiologists in distinguishing between benign breast areas and cancer tissue. This might help reducing the rate of call backs and unnecessary biopsies for patients. We expect to enroll 20 healthy postmenopausal women in this study. Conditions: Breast Cancer Intervention / Treatment: DRUG: letrozole Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Women are eligible to participate if they are 40 years or older and have been menopausal (had no menstrual bleeding during the past 12 months) Exclusion Criteria: * History of bilateral mastectomy, osteoporosis or renal impairment.

Study Objectives This study is to collect current information on complications rates of subjects undergoing chemotherapy administration through Ports and peripheral IVs. Conditions: PORTs/Peripheral IVs Complication Rates Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Male or female, age ≥ 21 years * Subject is currently undergoing or has had infusional cancer therapy (solid tumor or hematologic) through a Bard PORT with a distally-valved catheter/open-ended catheter or infusion through a PIV * Subject had a chemotherapy regimen consisting of a vesicant and/or irritant * Subject has signed an Informed Consent Form (ICF) or has had an ICF signed by the subject's legally authorized representative Exclusion Criteria: * Subject has/had an implanted non Bard PORT

Study Objectives The principal hypothesis of this study is that HPV testing and/or p16 testing, either alone or in combination or associated with a Pap smear, will demonstrate greater specificity for clinically significant precancerous disease than will a Pap smear alone and that these tests will be of comparable or superior sensitivity than the Pap smear. Conditions: Cervical Cancer Intervention / Treatment: OTHER: Diagnostic cervical cancer screening tests (Pap smear, HPV and/or p16) Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * 18 years and older * Ability to speak and clearly understand English * Female patients Exclusion Criteria: * No previous history of Cervical Cancer Treatment(LEEP,Laser,Cone etc.) * Women who have had Pap smears within the previous 10 months * Women under the age of 18. * Women who are pregnant. * Inability to give informed consent in English

Study Objectives The purpose of this study is to test whether it is safe to treat your cancer with 3 drugs instead of 2 drugs. After surgery, your cancer is typically treated with 2 drugs called cisplatin and paclitaxel (also known as Taxol). Cisplatin is given through a port in your belly, and Taxol is given both through the belly port and through the vein (IV). Large clinical studies have shown that this treatment gives the best results for women with your cancer. This treatment, however, also causes many side effects, especially belly pain, nerve injury, lowering of the immune system, and infection risk. In the study you are being asked to join, the dose of Cisplatin will be lower in order to try to lessen these problems. This study will also test the safety of adding a 3rd drug called bevacizumab (also known as Avastin). This drug has been shown to shrink ovarian, peritoneal, or fallopian tube cancer in some patients who have advanced disease, despite having received prior treatment for their cancer. Therefore, it may also be effective in patients, like you, who have a new diagnosis. Unfortunately, Avastin can cause some dangerous side effects in women with advanced cancer. For instance, it can cause a hole in the intestines, and can increase the risk of blood clots and strokes. Avastin has not been given at the same time as IP therapy, so it is not known if this is a safe or effective combination. In this study, IV Avastin will be given in addition to IP cisplatin, IP Taxol, and IV Taxol, to patients like you who have not had any chemotherapy before. This study aims to find out what effects, good and/or bad, that this combination of drugs has on your body and on your type of cancer. Conditions: Ovarian Cancer, Primary PERITONEUM, Fallopian Tube Cancer Intervention / Treatment: DRUG: Paclitaxel,Cisplatin, Bevacizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subjects must have signed an approved informed consent. * Subjects with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma, Stage II or III, with optimal (≤ or equal to 1 cm residual disease) residual disease following initial surgery. All subjects must have had appropriate surgery for ovarian, primary peritoneal, or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage. Pathology must be verified at Memorial Sloan-Kettering Cancer Center. * Subjects with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S. * Subjects must have a Karnofsky Performance Status (KPS) of ≥ or equal to 70%. * Subjects must be entered no more than 12 weeks postoperatively. * Bone marrow function: * Absolute neutrophil count (ANC) ≥ than or equal to 1,500/µl (equivalent to Common Toxicity Criteria (CTC) Grade 1) * Platelets ≥ than or equal to 100,000/µl (CTC Grade 0-1) * Renal function: Creatinine ≤ than or equal to 1.5 mg/dl * Hepatic function: Bilirubin ≤ than or equal to 1.5 x ULN (CTC Grade 1) AST ≤ than or equal to 2.5 x ULN (CTC Grade 1) * Neurologic function:Neuropathy (sensory) ≤ than CTC Grade 1 * Urine Protein Creatinine: Urine protein creatinine (UPC) ratio must be \< than 1.0 gm. If UPC ratio \> than or equal to 1, collection of 24-hour urine measurement of urine protein is recommended as part of the patient's medical management off-study. \* * UPC ratio of spot urine is an estimation of the 24 urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm. UPC ratio is calculated using one of the following formulas: * \[urine protein\]/\[urine creatinine\] - if both protein and creatinine are reported in mg/dL * \[(urine protein) x0.088\]/\[urine creatinine\] - if urine creatinine is reported in mmol/L * The UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection. Specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24 hour urine collection. Obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24 hour urine). Send sample to lab with request for urine protein and creatinine levels \[separate requests\]. The lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL). The UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL). Patients must have a UPCR \< 1.0 to allow participation in the study. * Blood coagulation parameters: PT such that international normalized ratio (INR) is \< than or equal to 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a PTT \< 1.2 times the upper limit of normal. * Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception during the study and for at least 6 months after receiving the final treatment of bevacizumab. * Patients must have an Intraperitoneal (IP) port in place. If a patient does not have an IP port, she must be willing to undergo surgical placement of one. Exclusion Criteria: * Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible. Subjects with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for any ovarian tumor. * Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than 3 years prior to enrollment, and the subject remains free of recurrent or metastatic disease. * Subjects who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Subjects may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than 3 years prior to enrollment, and that the subject remains free of recurrent or metastatic disease. * Patients with synchronous primary endometrial cancer, or a history of primary endometrial cancer, are excluded unless all of the following conditions are met: 1. Stage not greater than IB. 2. Less than 3 mm invasion without vascular or lymphatic invasion 3. No poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions * Patients with suboptimal (\> 1 cm) residual disease, as determined by the operative surgeon. * Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their ovarian, peritoneal primary, or fallopian tube cancer. * With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded. * Subjects with acute hepatitis. * Subjects with active infection that requires parenteral antibiotics. * Patients with serious, non-healing wound, ulcer, or bone fracture are not eligible. This includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days. Patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations. * Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels. * Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study. * Patients with clinically significant cardiovascular disease. This includes: 1. Uncontrolled hypertension, defined as systolic \>150 mm Hg or diastolic \> 90 mm Hg 2. Myocardial infarction or unstable angina \< 6 months prior to registration 3. New York Heart Association (NYHA) Grade II or greater congestive heart failure 4. Serious cardiac arrhythmia requiring medication 5. CTCAE grade 2 or greater peripheral vascular disease * Patients with major surgical procedure, open biopsy, laparoscopy (including intraperitoneal port placement) or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy. Major surgical procedure anticipated during the course of the study. Minor surgical procedures, fine needle aspirates, or core biopsies within 7 days prior to the first date of bevacizumab therapy. * Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies. * Patients under the age of 18. * Patients who are pregnant or nursing. * Evidence of extensive intraperitoneal adhesions at the time of surgery, as determined by the operative surgeon.

Study Objectives Female breast cancer is still the most frequent type of cancer in Europe with 21 per 100,000 women .The EORTC QLQ-BR23 was one of the first modules developed to be used in conjunction with the core questionnaire EORTC QLQ-C30 and was published in 1996. Since the beginning of the work on the EORTC QLQ-BR23 some 20 years ago, much knowledge has been gathered about the epidemiology of breast cancer, and major advances have been made with regard to diagnostic and therapeutic options. Therefore, the EORTC Quality of life group decided to update the BC23. A phase 1 to 3 module development project has been completed. This resulted in a 45 item module, retaining 23 of the original items and adding 22 new items, particularly tapping into the side effects of new systemic and local therapies. The aim of the Phase 4 study is to test the scale structure, reliability, responsiveness to change, and validity of the EORTC QLQ-BC45 in conjunction with the EORTC QLQ-C30 in patients diagnosed with breast cancer. Participants will be enrolled in four groups according to their disease stage (1. local/locally advanced disease, 2. metastatic disease, 3. follow up. Various combinations of therapies are permissible. According to sample size calculations, we will include a total of N =490 patients from 12 countries. Participants will be invited to complete the QLQ-C30 and the QLQ-BC45, followed by the Debriefing Questionnaire. Data of all patients will be used to evaluate the scale structure, internal consistency, convergent and discriminant validity. A subgroup of follow up patients with no evidence of disease (no change in health status) will be invited to complete the QLQ-C30 and the QLQ-BC45 for a second time one to two weeks later for the test-retest analysis. A subgroup of patients from the local/ locally advanced breast cancer group (who have had change in disease or treatment status after the first assessment) will be invited to complete a second set of questionnaires for the response to change analysis. Sociodemographic and clinical data will be recorded using standardized case report forms (CRF). Conditions: Cancer, Breast Cancer Intervention / Treatment: OTHER: EORTC QLQ-BR45 questionnaire Location: United Kingdom Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Adult females aged 18 years or over * Histologically confirmed diagnosis of breast cancer (any type) with no previous primary or recurrent tumour * Receiving or have previously received curative or palliative treatment. * Able to understand/speak English and complete the questionaires * Have the capacity/mental fitness to give written informed consent and complete the questionnaires. Exclusion Criteria: * Male gender or transgender * Inability to understand/speak English and complete the questionnaire * Patients with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper participation.

Study Objectives A Phase 1, Open-label, One-sequence Crossover Study to Investigate the Effect of a Breast Cancer Resistance Protein Inhibitor on the Single-dose Pharmacokinetics of Adagrasib in Healthy Adult Subjects Conditions: Healthy Adults Intervention / Treatment: DRUG: Adagrasib, DRUG: Eltrombopag + adagrasib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: OTHER Allocation: NON_RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: 1. Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening. 2. Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening. 3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, or clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator. 4. Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at Screening and Check-in. Females of childbearing potential must agree to use contraception. 5. Male subjects must agree to use contraception. 6. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions. Exclusion Criteria: 1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, thrombotic, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator. 2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the investigational product (IP), or other substance (not including seasonal allergies). 3. History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome). 4. Significant history or clinical manifestation of any hepatic disease, as determined by laboratory abnormalities. 5. History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study. 6. Ventricular dysfunction or history of risk factors for Torsades de Pointes. 7. History of drug abuse within 2 years prior to Screening. 8. History of alcohol abuse within 12 months prior to Screening. 9. Positive serology test results for hepatitis B surface antigen, hepatitis C antibody, and/or human immunodeficiency virus (HIV) 1/2. 10. Use of tobacco- or nicotine-containing products within 3 months prior to Check-in. 11. Use of any drugs or substances known or suspected to alter drug absorption, distribution, metabolism, or elimination. 12. Use or intend to use any prescription medications/products within 14 days prior to Check-in. 13. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations. 14. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days. 15. Subjects who, in the opinion of the Investigator, should not participate in this study.

Study Objectives The goal of this clinical research study is to learn if magnetic resonance imaging with magnetic resonance spectroscopy ("MRI/MRS" scanning) can measure any extra growth in the tumor that does not show up on regular MRI images. This study procedure will be performed on patients with recurrent glioblastoma who are either being treated with chemotherapy that blocks blood vessel growth, or will soon begin this type of chemotherapy. Conditions: Brain Tumor, Glioblastoma Intervention / Treatment: PROCEDURE: MRI/MRS Scan Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: 1. Patients with histologically proven intracranial glioblastoma or gliosarcoma will be eligible for this protocol 2. Patients with recurrent glioblastoma or gliosarcoma who are scheduled to start systemic chemotherapy with bevacizumab. 3. Patients tumor must be located in an area that is amenable to the proposed imaging sequences. 4. Patients must be age 18 or older. 5. Karnofsky Performance Status Scale (KPS) \>/= 70. 6. Inclusion of Women and Minorities: Both men and women and members of all races and ethnic groups are eligible for this trial. 7. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol. Exclusion Criteria: 1. Patients with histologically proven intracranial glioblastoma or gliosarcoma will be eligible for this protocol 2. Patients with recurrent glioblastoma or gliosarcoma who are scheduled to start systemic chemotherapy with bevacizumab. 3. Patients tumor must be located in an area that is amenable to the proposed imaging sequences. 4. Patients must be age 18 or older. 5. KPS \>/= 70. 6. Inclusion of Women and Minorities: Both men and women and members of all races and ethnic groups are eligible for this trial. 7. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policies of the hospital.

Study Objectives Tumours continually shed DNA into the circulation, where it can be accessed. This circulating tumour DNA (ctDNA) directly reflects tumour burden and has great potential to be a sensitive biomarker for treatment recurrence. These "liquid biopsies" could give a more real-time picture of the genomic status and evolution of a tumour and can be easily assessed for measurement of different biomarkers. However, in head and neck squamous cell carcinoma (HNSCC) patients treated with primary curative radiotherapy, data regarding ctDNA kinetics and its correlation with outcome are scarce. A new or additional tool for response evaluation next to or instead of conventional imaging after treatment would be beneficial to detect recurrences in an earlier stage, thereby increasing the chances of success of salvage therapy. More importantly, an early response parameter during treatment could help to identify patients that have a good treatment response and might benefit from treatment adaptation. With this study, we aim to reveal ctDNA as an effective tool for future dose (de)-escalation trials in HNSCC. Conditions: Carcinoma, Squamous Cell of Head and Neck Intervention / Treatment: OTHER: Blood draw Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * ≥ 18 years of age * Stage II-IV carcinoma of the larynx, hypopharynx, oral cavity or HPV negative oropharynx or stage II-III HPV positive oropharyngeal carcinoma, histologically confirmed according to the American Joint Committee on Cancer (AJCC) staging manual 8th edition * Indication for primary curative radiotherapy with or without concurrent radio sensitizer * WHO performance status 0-2 * Signed written IC Exclusion Criteria: * Metastatic disease * Radiotherapy with palliative intent * Diagnosis of any other malignancy within 5 years prior to start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason 6 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g. surgery, radiation or castration).

Study Objectives The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 150 mg may prevent the use of morphine during the first day after laparoscopic ovarian cyst surgery. Conditions: Ovarian Cysts Intervention / Treatment: DRUG: Ropivacaine nebulization, DRUG: Ropivacaine instillation Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Females 18-65 years old * ASA Score I-III * Scheduled for ovarian cyst laparoscopic surgery * Free from pain in preoperative period * Not using analgesic drugs before surgery * Without cognitive impairment or mental retardation * Written informed consent Exclusion Criteria: * Emergency/urgency surgery * Postoperative admission in an intensive care unit * Cognitive impairment or mental retardation * Progressive degenerative diseases of the CNS * Seizures or chronic therapy with antiepileptic drugs * Severe hepatic or renal impairment * Pregnancy or lactation * Allergy to one of the specific drugs under study * Acute infection or inflammatory chronic disease * Alcohol or drug addiction

Study Objectives RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients with sarcoma. Conditions: Ovarian Cancer, Sarcoma Intervention / Treatment: DRUG: cyclophosphamide, DRUG: doxorubicin hydrochloride, DRUG: etoposide, DRUG: ifosfamide, DRUG: vincristine sulfate, PROCEDURE: adjuvant therapy, PROCEDURE: neoadjuvant therapy, PROCEDURE: therapeutic conventional surgery, RADIATION: brachytherapy, RADIATION: intraoperative radiation therapy, RADIATION: radiation therapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking:

DISEASE CHARACTERISTICS: * Diagnosis of any of the following: * High-grade nonmetastatic, nonrhabdomyosarcomatous soft tissue sarcomas (excluding undifferentiated sarcoma and Ewing sarcoma) * Small round cell sarcomas (excluding primitive neuroectodermal tumors of soft tissue) (closed to accrual) * Undifferentiated sarcomas (closed to accrual) * Rhabdomyosarcomas (excluding non-parameningeal head tumors, vaginal or stage I paratesticular) (closed to accrual) * All alveolar rhabdomyosarcomas (closed to accrual) * No evidence distant metastatic disease (i.e., lung, bone, bone marrow) * Local or regional nodal disease allowed * No spindle cell tumors of bone * Primary lesions do not have to be resectable PATIENT CHARACTERISTICS: * Creatinine ≤1.5 mg/dL OR creatinine clearance \> 60 mL/min/ * AST/ALT \< 2 times upper limit of normal (ULN) * Total bilirubin \< 2 times ULN * LVEF ≥ 45% * No prior history of cancer * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: * Patients who have undergone radiation therapy after initial surgery are eligible but must have evaluation for metastatic disease within 2 weeks of starting chemotherapy * No prior chemotherapy

Study Objectives RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in tissue samples from patients with recurrent and/or metastatic squamous cell cancer of the head and neck previously treated with cisplatin with or without cetuximab. Conditions: Head and Neck Cancer Intervention / Treatment: OTHER: immunohistochemistry staining method, OTHER: laboratory biomarker analysis, OTHER: medical chart review Location: Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: * Diagnosis of squamous cell carcinoma of the head and neck * Recurrent and/or metastatic disease * Received cisplatin with or without cetuximab on clinical trial ECOG-E5397 * Slides and blocks of tumor specimens available PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Study Objectives Breast cancer survivors, from diagnosis until the end of life, go through many transitions. One major transition is the significant decrease of physical activity immediately after diagnosis. Despite the known benefits of physical activity-speeding recovery time and reduced cancer recurrence risk-only 1 in 3 survivors met physical activity recommendations of 150 minutes of moderate-intensity activity per week. Physical activity interventions have shown effectiveness in helping breast cancer survivors increase physical activity during treatment, but limited evidence-based physical activity interventions have been incorporated into the clinic and community. To address this limitation, the investigators are partnering with the UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink Warrior. The goal of this study is to compare an intervention that uses active games versus an intervention uses pedometer to encourage physical activity such as walking within breast cancer survivors in active cancer treatment. The study will include breast cancer survivor between the ages of 18 - 70 whom currently gets less than 150 minutes of planned physical activity per week and received a breast cancer diagnosis within 0 to 6 months. Participants will be randomized to participate in the support group using the active video game-based physical activity intervention (Wii and Xbox active games) or to participate in the existing UTMB breast cancer support group with pedometers (Digi-Walker CW-700/701). The investigators hypothesize that by engaging in active video gaming, breast cancer survivors will be motivated to initiate and maintain physical activity during treatment. This will ultimately increase functional capacity and prevent functional disability in breast cancer survivors. Conditions: Breast Cancer, Physical Activity Intervention / Treatment: BEHAVIORAL: Active video game teleconference support group, BEHAVIORAL: Standard support group + pedometer Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: 1. Provide informed consent 2. Diagnosed with primary female breast cancer 3. 55 years to 79 4. Able to speak, read, and write in English 5. Able to travel to UTMB locations and/or MD Anderson Victory Lakes 6. Able to move arms and les as well as ambulate 7. Has a smartphone, tablet or computer and daily access to a reliable internet Exclusion Criteria: 1. Pregnancy 2. Diagnosed dementia 3. Currently engage in 150 minutes or more of planned moderate intensity physical activity 4. Currently involved in another physical activity intervention

Study Objectives CENTRIC is a Phase 3 clinical trial assessing efficacy and safety of the investigational integrin inhibitor, cilengitide, in combination with standard treatment versus standard treatment alone in newly diagnosed glioblastoma subjects with a methylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue. The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to be a predictive marker for benefit from temozolomide (TMZ) treatment. Conditions: Glioblastoma Intervention / Treatment: DRUG: Cilengitide, DRUG: Temozolomide, RADIATION: Radiotherapy Location: Germany, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: 1. Tumor tissue specimens from the glioblastoma surgery or open biopsy (formalin-fixed, paraffin-embedded block; stereotactic biopsy not allowed) must be available for MGMT status analysis and central pathology review 2. Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization \[WHO\] Grade IV) 3. Proven methylated MGMT gene promoter methylation status 4. Available post-operative gadolinium-enhanced magnetic resonance imaging (Gd-MRI) performed within less than (\<) 48 hours after surgery (in case it was not possible to obtain a Gd-MRI within \<48 hours post surgery, a Gd-MRI is to be performed prior to randomization) 5. Stable or decreasing dose of steroids for greater than or equal to (\>=) 5 days prior to randomization 6. Eastern Cooperative Oncology Group performance score (ECOG PS) of 0-1 7. Meets 1 of the following recursive partitioning analysis (RPA) classifications: Class III (Age \< 50 years and ECOG PS 0). Class IV (meeting one of the following criteria: a) Age \< 50 years and ECOG PS 1 or b) Age \>= 50 years, underwent prior partial or total tumor resection, mini mental state examination \[MMSE\] \>= 27). Class V (meeting one of the following criteria: a) Age \>= 50 years and underwent prior partial or total tumor resection, MMSE \< 27 or b) Age \>= 50 years and underwent prior tumor biopsy only) 8. Other protocol defined inclusion criteria could apply Exclusion Criteria: 1. Prior chemotherapy within the last 5 years 2. Prior RTX of the head 3. Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of cilengitide 4. Prior systemic antiangiogenic therapy 5. Placement of Gliadel® wafer at surgery 6. Inability to undergo Gd-MRI. 7. Planned surgery for other diseases 8. History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment 9. History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for \>= 5 years are eligible for this study 10. History of coagulation disorder associated with bleeding or recurrent thrombotic events 11. Clinically manifest myocardial insufficiency (New York Heart Association \[NYHA\] III, IV) or history of myocardial infarction during the past 6 months; uncontrolled arterial hypertension 12. Other protocol defined exclusion criteria could apply

Study Objectives In spite of long-standing hypothesis relating diet and physical activity to several cancers, diet and physical activity-cancer associations have been modest at best and often inconsistent in epidemiologic studies. Investigators around the world have become increasingly concerned that error in the measurement of both diet and physical activity is compromising our ability to detect these important but modest associations. Most commonly used diet and physical activity assessment methods have been based on a relatively small set of questions (e.g. 124 food items consumed or 5-10 physical activities in the past 12 months). Recent developments in computer technology provide an opportunity to use internet-based instruments to assess an individual s diet and physical activity more accurately and cost effectively. Conditions: Cancer Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

* We will recruit 5,000 subjects from the existing NIH-AARP study participants who are currently 62 to 83 years old. To include individuals who are at least 50 years old, we will expand our recruitment effort to 10,000 new AARP members who are at least 50 years old and not currently NIH-AARP study cohort members. We will target individuals residing in one of the following states: Florida; Pennsylvania; New Jersey; Louisiana; North Carolina; California; Detroit; Michigan; and Atlanta, Georgia, Nevada, Arizona, Texas, Illinois, Washington, Wisconsin, Colorado, Connecticut, Kentucky, Utah and Massachusetts (subject to change due to availability of high-quality state cancer registries). The names and addresses of new AARP members will be provided by AARP.

Study Objectives In this study it was the rationale to evaluate the safety and tolerability of the combined administration of nilotinib and increasing dose of ruxolitinib in patients with chronic myeloid leukemia and patients with Philadelphia positive acute lymphoblastic leukemia. Conditions: Chronic Myeloid Leukemia Intervention / Treatment: DRUG: Nilotinib, DRUG: Ruxolitinib Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Patients of the first stratum must have chronic myeloid leukemia receiving nilotinib first-line therapy or receiving second-line or subsequent-line treatment with nilotinib. Patients of the second stratum must have CML in AP/BC or relapsed/refractory Ph+ ALL, or be Ph+ ALL patients with MRD with or without prior nilotinib pretreatment; Patients must have adequate end organ function, as defined by: * Creatinine \< 2.0 x upper limit of normal (ULN) * Total bilirubin \< 1.5 x ULN (\< 3.0 x ULN if related to disease or polymorphism, such as Mb. Gilbert) * ALT and AST \< 2.5 x ULN (\< 5.0 x ULN if related to disease) * Serum lipase ≤ 1.5 x ULN * Alkaline phosphatase ≤ 2.5 x ULN (\< 5.0 x ULN if related to disease); Patients must have the following electrolyte values within normal limits or corrected to within normal limits with supplements prior to the first dose of study medication: * Potassium * Magnesium * Phosphate * Total calcium (corrected for serum albumin); Female patients of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days before initiation of study drug. All WOCBP must use highly effective contraceptive methods throughout and during 3 months after study; Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 for patients in CP, ≤ 2 for patients in AP/BC or with relapsed/refractory Ph+ ALL or with Ph+ ALL with MRD; Patient has the following laboratory values within 7 days of starting study drug: - For CML and Ph+ ALL patients: platelet count \> 75 x 109/L and ANC \> 1.0 x 109/L Exclusion Criteria: Patient must not have evidence of active malignancy other than the existing CML or ALL Patient must not receive drugs that interfere with coagulation or inhibits platelet function, with the exception of aspirin ≤ 150 mg per day or low molecular weight heparin. Patient must not have history of platelet dysfunction, bleeding diathesis, and/or coagulopathy in the 6 months prior to screening; Patient must not require treatment with any strong CYP3A4 inducer or inhibitor Patient must not have history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes and their excipients; Patients must not take other investigational drugs within 28 days prior to screening; Patient must not be pregnant or lactating at screening and/or baseline; Patient must not have impaired cardiac functions Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives This study will look at caregiver burden and the coping behavior of caregivers of patients with cancer. Through this study, the investigators will identify the relationship between cognitive dysfunction (measured as a proxy rating by the caregiver), resilience, social support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression among family caregivers of patients with cancer. Conditions: Caregivers, Cancer Intervention / Treatment: OTHER: Questionnaire Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Age ≥ 18 years * Self-identified primary caregiver of patients with cancer * Co-residence with the patient * Providing a minimum of 4 hours of direct care for at least 3 days per week * Able to speak, read, and understand English * Willing to participate in completion of surveys Exclusion Criteria: * Professional or paid caregivers

Study Objectives An open-label, single center study with 99mTc-ADAPT6 and 99mTc-DARPinG3 SPECT and biopsies of primary tumour in HER2-positive Breast Cancer before system (chemo/targeted) therapy, where the primary endpoint of the study is to compare imaging properties of 99mTc-ADAPT6 and 99mTc-DARPin G3 SPECT in HER2-positive breast cancer patients. Conditions: Breast Cancer Female Intervention / Treatment: DRUG: 99mTc-ADAPT6, DRUG: 99mTc-DARPinG3 Location: Russian Federation Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: 1. Subject is \> 18 years of age; 2. Diagnosis of primary breast cancer with possible lymph node metastases before system (chemo+targeted therapy); 3. Availability of results from HER2 status previously determined on material from the primary tumor: HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive; 4. Sequential injection of 99mTc-ADAPT6 and 99mTc-DARPinG3 in the interval of 3-4 days in each HER2-positive breast cancer patient; 5. Hematological, liver and renal function test results within the following limits: * White blood cell count: \> 2.0 x 109/L * Hemoglobin: \> 80 g/L * Platelets: \> 50.0 x 109/L * ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal * Bilirubin =\< 2.0 times Upper Limit of Normal * Serum creatinine: Within Normal Limits 6. A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination; 7. Subject is capable to undergo the diagnostic investigations to be performed in the study; 8. Informed consent Exclusion Criteria: 1. Second, non-breast malignancy 2. Active current autoimmune disease or history of autoimmune disease 3. Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. Known HIV positive or chronically active hepatitis B or C 5. Administration of other investigational medicinal product within 30 days of screening 6. Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's -

Study Objectives RATIONALE: Video-assisted surgery followed by radiation therapy may be an effective treatment in patients whose poor heart and lung function make them high risk for standard surgery. PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery followed by radiation therapy in treating patients with stage I non-small cell lung cancer and poor heart and lung function. Conditions: Lung Cancer Intervention / Treatment: PROCEDURE: adjuvant therapy, PROCEDURE: diagnostic thoracoscopy, PROCEDURE: therapeutic thoracoscopy, PROCEDURE: video-assisted surgery, RADIATION: radiation therapy Location: Australia, United States, Puerto Rico, Peru Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: * Known or suspected, single, peripheral, stage T1 N0 M0 lung tumor * Tumor must not be identifiable by bronchoscopy * Bronchoscopically visible cancer or bronchial distortions considered related to tumor * Positive cytology by bronchoscopy allowed if no gross abnormality visible * Mediastinoscopy required for nodes greater than 1 cm * No pleural effusions * No metastatic or N2 disease on CT scan * Lesion must be accessible for video-assisted thoracoscopic wedge resection * High cardiopulmonary risk for thoracotomy with at least 1 of the following criteria: * FEV1 less than 40% predicted * DLCO less than 50% predicted * Supplemental oxygen requirement * Chronic PaCO2 greater than 45 mm Hg * Maximum oxygen consumption (VO2 max) less than 15 mL/kg/min * Patients who appear at high risk for non-pulmonary reasons (e.g., patients who are elderly or with renal or cardiac failure) may be eligible only if VO2 max or other criteria above are met * Eligible for radiotherapy after completion of wedge resection if histologic documentation of non-small cell lung cancer, including any of the following subtypes: * Squamous cell carcinoma * Adenocarcinoma * Bronchoalveolar cell * Large cell anaplastic carcinoma * Cytology from bronchial washings and transthoracic needle aspiration not acceptable PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * 0-2 Other: * No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix * Weight loss no greater than 10% within the past 6 months PRIOR CONCURRENT THERAPY: Radiotherapy * No prior thoracic irradiation

Study Objectives The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases. Conditions: Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer, Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma Intervention / Treatment: GENETIC: AMG 162 180 mg (SC) q 12 weeks, DRUG: IV Bisphosphonate q 4 weeks, GENETIC: AMG 162- 180 mg q 4 weeks Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients at least 18 years of age with histologically confirmed solid tumor carcinomas (except lung) or multiple myeloma * Radiographic evidence of 1 or more bone lesions or lytic lesion in myeloma * Currently receiving IV bisphosphonates * Urinary N-Telopeptide (uNTx) greater than 50 nM BCE/mM creatinine * Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 Exclusion Criteria: * More than 2 prior skeletal related events (SRE) * Known brain metastases * Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw * Active dental or jaw conditions which requires oral surgery * Non-healed dental/oral surgery * Prior administration of AMG 162 * Evidence of impending fracture in weight bearing bones * Pregnancy or breastfeeding. Subjects must be surgically sterile, postmenopausal, or must agree to use effective contraception during the study.

Study Objectives RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Drugs such as mesna may be effective in preventing some of the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of etoposide and ifosfamide given with mesna, and cisplatin in treating patients who have metastatic breast cancer. Conditions: Breast Cancer Intervention / Treatment: DRUG: cisplatin, DRUG: etoposide, DRUG: ifosfamide, DRUG: Mesna Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: * Histologically proven progressive metastatic breast cancer * Measurable disease * Any lesion measurable in 2 dimensions * Hepatic metastases if the sum of the measurements below the costal margin in the midclavicular line and the tip to the xiphoid process is greater than 5 cm during quiet respiration * Hepatic defects that are clearly measurable by radionuclide, CAT, or MRI scans * Bone metastases are not considered measurable disease * Evaluable disease allowed if measurable disease also present * No brain metastases, carcinomatous meningitis, or spinal cord compression * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * Not specified Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Hemoglobin at least 10 g/dL * WBC at least 4,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 2.0 mg/dL Renal: * Creatinine no greater than 1.5 mg/dL * No bladder outlet obstruction Cardiovascular: * No symptomatic cardiovascular disease (e.g., congestive heart disease) or inability to tolerate a fluid load Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection * No prior malignancies except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No greater than 1 prior biologic response modifier treatment for metastatic disease Chemotherapy: * No greater than 1 prior chemotherapy regimen for metastatic disease allowed * Patients who relapsed during or within 6 months after adjuvant chemotherapy are considered to have failed 1 regimen * Patients who relapsed more than 6 months after adjuvant chemotherapy are considered to not have had a prior regimen * Greater than 4 weeks since prior chemotherapy (greater than 6 weeks for mitomycin or nitrosoureas) and recovered * No prior cisplatin, etoposide, or ifosfamide Endocrine therapy: * Prior medical or surgical hormonal therapy allowed Radiotherapy: * Prior radiation therapy to areas of measurable disease allowed if indicator lesion increased in size by greater than 25% after treatment * Recovered from effects of prior radiotherapy Surgery: * Recovered from effects of major surgery Other: * At least 7 days since prior nephrotoxic drugs (e.g., aminoglycosides, diuretics, lithium, intravenous contrast, or nonsteroidal antiinflammatory drugs)

Study Objectives Informal caregivers provide a majority of care for patients during serious illness. Lack of preparation and completion may leave caregivers less capable of caring for a loved one or making crucial decisions influencing care. This study will examine whether a preparation and completion intervention reduces caregiver anxiety, depression, anticipatory grief, and burden and improves patient quality of life and health care use. Conditions: Heart Failure, Pulmonary Disease, Cancer Intervention / Treatment: OTHER: Preparation and life completion, OTHER: Attention Control Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Patients with advanced cancer/Congestive heart failure/COPD/End stage renal disease who have a primary caregiver. Caregivers of Durham VAMC patients with advanced disease. Exclusion Criteria: * No caregiver present. * Caregiver with Cognitive impairment/inability to speak on phone/non-English speaking

Study Objectives This study is being done to see whether Avmacol®, a dietary supplement made from broccoli sprout and seed extract powder, induces changes in inner cheek cells that may be protective against environmental toxins such as tobacco. There are three main goals of the study: 1. To learn whether the dietary supplement, Avmacol®, can stimulate cheek cells to repair damage from environmental toxins; 2. to learn how the body metabolizes Avmacol®, by measuring its byproducts in the participant's urine and blood; 3. to learn whether the immune system can be stimulated by Avmacol®, by studying the natural killer cells and T cells in the participant's blood. Conditions: HNSCC, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Tobacco-Related Carcinoma, Carcinoma in Situ, Dysplasia, Hyperplasia, Premalignant Lesion Intervention / Treatment: DRUG: Avmacol® Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

Inclusion Criteria: * Patients must have completed curative-intent therapy (including surgery, radiation, and/or chemotherapy) for a first tobacco-related oral premalignant lesion (OPL) or HNSCC of any stage (eligible lesions include high grade dysplasia; carcinoma in situ; or stage I-IVa HNSCC). * Primary site may include oral cavity, pharynx, or larynx. Oropharynx primaries must be human papillomavirus (HPV) negative as defined by routine p16 IHC at the local site. * Patients may be enrolled between 3 months and 5 years AFTER completion of curative-intent therapy (including surgery, radiotherapy, and/or chemotherapy). * Patients may have untreated OPLs (i.e., hyperplasia, dysplasia, carcinoma in situ) at the time of study entry, provided the index OPL or HNSCC was definitively treated. * Patients must have a Karnofsky Performance Status of 80% or higher or an Eastern Cooperative Oncology Group (ECOG) of 0-1 * Current and former tobacco users are eligible. * Able to perform written, informed consent. * Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 Days prior to the first study intervention. * WCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation. Exclusion Criteria: * Patient has a history of another malignancy within 2 years prior to starting study treatment, except for excised and cured carcinoma-in-situ of breast or cervix; non-melanomatous skin cancer; T1-2, N0, M0 differentiated thyroid carcinoma either resected or under active surveillance; superficial bladder cancer; T1a or T1b prostate cancer comprising \< 5% of resected tissue with normal prostate specific antigen (PSA) since resection, or status post external beam radiation or brachytherapy with normal PSA since radiation. * Primary oropharyngeal HNSCC which is HPV (+) as defined by p16 immunohistochemistry. * Participants with acute intercurrent illness or those who had major surgery within the preceding 4 weeks unless they have fully recovered. * Participants who have a positive pregnancy test, are pregnant, or breast feeding. * Patients who are not practicing adequate contraception are ineligible if they are of child bearing potential. * Patients currently using anti-neoplastic or anti-tumor agents, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy. * Chronic anticoagulation with warfarin. Patients on low molecular weight heparin or fondaparinux may be enrolled. * Use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4 * Chronic use of steroids at immunosuppressive doses. * History of severe food intolerance to broccoli.

Study Objectives RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking at a biomarker, 11-dh-TXB2, in blood and urine samples from patients with prostate cancer and healthy volunteers. Conditions: Prostate Cancer Intervention / Treatment: OTHER: high performance liquid chromatography, OTHER: laboratory biomarker analysis, OTHER: mass spectrometry Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: * Meets one of the following criteria: * Histopathologically confirmed prostate cancer meeting 1 of the following criteria: * Newly diagnosed untreated disease * Received prior local therapy (prostatectomy, definitive radiotherapy, brachytherapy, or cryotherapy) with no evidence of disease activity (defined as serum PSA \< 0.4 ng/mL post therapy) and by imaging studies * Experienced biochemical failure (defined as rise in serum PSA ≥ 0.4 ng/mL post therapy) * Healthy volunteer (clinic patient with no history of clinically significant malignancies within the past 6 months) PATIENT CHARACTERISTICS: * No clinical evidence of liver cirrhosis or chronic liver disease (i.e., evidence of ascites or severe coagulopathy) * No active prostatitis PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 30 days since prior and no concurrent regular antiplatelet agents (including aspirin, anagrelide, cilastazole, clopidogrel, dipyridamole, pentoxiphylline, sulfinpyrazone, or ticlopidine) * More than 7 days since prior and no concurrent NSAIDs (including ibuprofen, celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, indomethacin, ketoprofen, meclofenamate, mefenamic acid, nabumetone, naproxen, oxaprozin, piroxicam, sulindac, or tolmetin)

Study Objectives Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who underwent leukapheresis. These cells were processed based on a novel method for ex vivo activation and expansion using an irradiated and activated autologous feeder cell system. MG4101 has anti-tumor activities against various tumors including malignant lymphomas in vitro as well as in vivo tumor model. Conditions: Malignant Lymphomas, Solid Tumors Intervention / Treatment: BIOLOGICAL: Allogeneic NK cells Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Age 18 years or older * Histologically or cytologically confirmed malignant lymphoma or solid tumor * After the failure of standard treatment * KPS \>70 or ECOG PS 0-2 * Adequate bone marrow, renal, and liver functions * Expected survival at least 3 months * Informed consent Exclusion Criteria: * Pregnancy or lactating woman * HIV patients * Prior exposure to cell-based therapy * Hypersensitivity to interleukin-2 * Patients with autoimmune disease

Study Objectives We aimed to investigate visceral adiposity index (VAI) in patients with different phenotype of policystic ovary syndrome (PCOS) and to compare healthy controls. Conditions: Visceral Adiposity Index, Polycystic Ovary Syndrome Intervention / Treatment: Location: Turkey Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: 1. Patients who applied for reasons such as hair growth, acne, menstrual irregularity or infertility and were diagnosed with PCOS after examination, biochemical, hormonal and sonographic tests, 2. Female patients between the ages of 18-35, 3. Patients without known cancer, liver or kidney failure, 4. Patients who do not take medications that will affect HDL, TG levels and insulin resistance, 5. Female patients without active infection will be included. - Exclusion Criteria: 1. Female patients under eighteen years of age and \&gt;35 years of age, 2. Patients with known cancer, liver and kidney failure, 3. Patients taking medications that will affect HDL, TG levels and insulin resistance, 4. Patients with active infection will not be included in the study. -

Study Objectives More than 5 years ago the DVT FREE Registry was conceived. Its database consists of 5,451 ultrasound-confirmed DVT patients from 183 institutions. This database is rich in information of critical importance to health care providers. The information contained within the database will be revisited to provide more detailed analyses which will be used for risk factor assessment and for decision-making regarding the implementation of VTE Prophylaxis. Conditions: Venous Thromboembolism, Pulmonary Embolism, Cancer, Deep Vein Thrombosis, COPD Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Ultrasound-confirmed DVT patients from 183 institutions.

Study Objectives Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety and efficacy of distinct temozolomide treatment regimens for patients with AML and poor prognosis Conditions: Leukemia, Myeloid Intervention / Treatment: DRUG: Temozolomide 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: 1. Patients must have histologically or cytologically confirmed Acute Myeloid Leukemia, as defined by the WHO classification. 2. Patients must be considered unfit for conventional induction chemotherapy, unwilling to receive such treatment or have evidence of disease relapse or refractory disease. 3. For patients who have received no prior conventional chemotherapy, one of the following must be present: * Poor risk cytogenetics (complex abnormalities, deletions of chromosome 7 or 5, 11q23 abnormalities, inv\[3\]) * Secondary leukemia (prior hematologic disorder or therapy-related leukemia). 4. Age \> 60 years of age. 5. Life expectancy of greater than 3 months. 6. ECOG performance status greater than 2. 7. Patients must have normal organ and marrow function as defined below: 8. Adequate hepatic function: Total bilirubin 1.5mg/dL, AST(SGOT)/ALT(SGPT) 2.5 X institutional upper limit of normal. 9. Adequate renal function: serum creatinine within normal institutional limits or Calculated creatinine clearance \> 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. 10. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. 2. Patients may not be receiving any other investigational agents. 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or DTIC 4. History of gastrointestinal disease or significant bowel resection that could interfere with drug absorption. 5. 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. 6. Prior allogeneic stem cell transplantation. 7. Inability to swallow tablets 8. Prior radiation up to more than 25% of bone marrow.

Study Objectives The primary objective of this study is to compare the diagnostic accuracy of Digital Breast Tomosynthesis (DBT) versus that of Contrast Enhanced Magnetic Resonance Imaging (CEMRI) in determining the size of breast cancer preoperatively. Secondary objectives include: 1. Comparing the operating characteristics of each combined imaging protocol with respect to the reference standard, i.e. histopathologic assessment, of additional non-index lesions. 2. Comparison of re-excision rates based on estimated disease extent from adjunctive CEMRI vs. adjunctive DBT. 3. Evaluation of patient satisfaction with regard to the adjunctive modality (DBT vs. CEMRI). Conditions: Ductal Carcinoma In Situ, Invasive Breast Cancer Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Subject is female of any race and ethnicity * Subject is at least 30 years old * Subject has histologically proven DCIS or invasive breast carcinoma. * Subject is able to undergo CEMRI at DHMC-Lebanon Exclusion Criteria: * Patients who are pregnant or think they may be pregnant * Patients who are breast-feeding. * Patients who have significant existing breast trauma * Subjects unable or unwilling to undergo informed consent * Absolute contraindication to CEMRI, including: 1. presence of implanted electrical device (pacemaker or neurostimulator),aneurysm clip, or metallic foreign body in or near the eyes 2. life threatening allergy to gadolinium contrast * CEMRI performed at institution other than DHMC Lebanon * Patients undergoing neoadjuvant therapy * Patients with maximum tumor diameter \>5cm * Patients presenting with Inflammatory Breast Cancer * Patients with gross axillary lymphadenopathy on clinical exam or by imaging * Maximum breast size limitation: i.e. breast size that exceeds the size of the large format image receptor (24cm x 29cm) on any view

Study Objectives RATIONALE: Tyrosine kinase inhibitors may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer cells. GM-CSF may help cells that are involved in the body's immune response work better. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. PURPOSE: This randomized phase II trial is studying tyrosine kinase inhibitors, interferon alfa, and GM-CSF to see how well they work compared to tyrosine kinase inhibitors and vaccine therapy in treating patients with chronic phase chronic myelogenous leukemia. Conditions: Leukemia Intervention / Treatment: BIOLOGICAL: GM-K562 cell vaccine, BIOLOGICAL: Interferon alfa, BIOLOGICAL: Sargramostim Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: NONE

DISEASE CHARACTERISTICS: * Diagnosis of chronic myelogenous leukemia (CML) in chronic phase based on cytogenetic detection of the Philadelphia chromosome and/or detection of the BCR-ABL rearrangement by any of the following molecular methods: * Recombinant DNA analysis of the BCR-ABL fusion gene * Fluorescence in situ hybridization (FISH) * Polymerase chain reaction detection of the BCR-ABL hybrid mRNA * Documentation of complete cytogenetic response by conventional cytogenetic or FISH analysis while on a stable dose of tyrosine kinase inhibitor * No other phase of CML PATIENT CHARACTERISTICS: * ECG performance status 0-2 * Life expectancy \> 24 months * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * Creatinine ≤ 2.0 mg/dL * Bilirubin ≤ 2.0 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * No other malignancy within the past 5 years except in situ cervical carcinoma or adequately treated nonmelanoma skin cancer * No other disease requiring long-term corticosteroids or immunosuppressants PRIOR CONCURRENT THERAPY: * At least 28 days since prior investigational agents * No prior bone marrow transplant or other transplant * No concurrent immunosuppressants (e.g., steroids, cyclosporine, azathioprine, mycophenolate mofetil, sirolimus, or tacrolimus) * No concurrent hydroxyurea, busulfan, or cytoreductive agents (other than frontline TKI) * No other concurrent anticancer agents or therapies

Study Objectives An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500 µg was based on antibody response and dose tolerability. Conditions: Gastric Cancer Intervention / Treatment: BIOLOGICAL: G17DT Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed UICC Stage I, II or III gastric adenocarcinoma. Must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial * Male or female and over 18 years of age * Must have a life expectancy of at least three months * World Health Organization Performance Status of 0 to 1 * Given written conformed consent Exclusion Criteria: * Gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated in the period of the study * History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix * Previous use within the last four weeks, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies * Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids * Females who pregnant, planning to become pregnant or lactating * Taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study * Previously received G17DT treatment * Haemoglobin (Hb) \< 10.0 g/dL White blood cell count (WBC) \< 4.0 x 10\^9/L Platelets \< 100 x 10\^9/L

Study Objectives RATIONALE: Bortezomib and pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with pemetrexed disodium may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of two different schedules of bortezomib when given together with pemetrexed disodium and to see how well they work in treating patients with advanced non-small cell lung cancer or other solid tumors. Conditions: Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: bortezomib, DRUG: pemetrexed disodium, GENETIC: gene expression analysis, GENETIC: mutation analysis, GENETIC: protein expression analysis, GENETIC: reverse transcriptase-polymerase chain reaction, OTHER: flow cytometry, OTHER: immunoenzyme technique, OTHER: immunohistochemistry staining method Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: * Cytologically or histologically confirmed diagnosis of 1 of the following: * Advanced solid tumor that progressed after standard therapy or for which no effective curative therapy exists (phase I) * Stage IIIB (pleural effusion) or IV non-small cell lung cancer (NSCLC) (phase II) * Disease must have progressed or recurred after 1 platinum-based therapy regimen * NSCLC that has progressed or recurred after first-line therapy for stage IIIA or IIIB disease allowed * Measurable disease * Disease in previously irradiated sites is considered measurable if there is clear disease progression following radiotherapy * Evaluable disease (bone metastases, pleural fluid, ascites) allowed (phase I) * No symptomatic brain metastasis or disease requiring steroids and anticonvulsants * Asymptomatic, previously treated (surgical resection or radiotherapy) brain metastases allowed provided patient is neurologically stable and has been off steroids and anticonvulsants for ≥ 4 weeks PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 (phase I) or 0-1 (phase II) * Life expectancy ≥ 3 months * Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min * Bilirubin normal * AST ≤ 2.5 times upper limit of normal * Granulocyte count ≥ 1,500/mm³ * Platelet count of ≥ 100,000/mm³ * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No pre-existing neuropathy ≥ grade 2 * No other prior malignancy except for the following (phase II): * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Adequately treated stage I or II cancer currently in complete remission * Any other cancer from which the patient has been disease free for \> 5 years * No hypersensitivity to bortezomib, boron, or mannitol * No cardiovascular complications, including any of the following: * Myocardial infarction within the past 6 months * New York Heart Association class III-IV heart failure * Uncontrolled angina * Severe uncontrolled ventricular arrhythmias * Electrocardiographic (ECG) evidence of acute ischemia or active conduction system abnormalities * Any ECG abnormality at screening must be documented as not medically relevant PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior bortezomib or pemetrexed disodium * Any number of prior chemotherapy regimens allowed (phase I) * More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C) and recovered * More than 2 weeks since prior radiotherapy and recovered * No nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates 2 days prior and 2 days after (5 days pre and post for long-acting NSAIDs) administration of pemetrexed disodium * No concurrent anticonvulsants that are metabolized by the cytochrome P450 pathway

Study Objectives The purpose of this study is to determine whether nab-Paclitaxel (Abraxane®) and ramucirumab (Cyramza®) are effective when used in combination for treating patients with metastatic gastroesophageal cancer who have either progressed or not responded to prior therapy. Conditions: Gastroesophageal Cancer Intervention / Treatment: DRUG: nab-paclitaxel, BIOLOGICAL: ramucirumab 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: 1. Patients with histologically confirmed metastatic adenocarcinoma of the esophagus, GE junction, or stomach who progressed on one prior line of chemotherapy in the metastatic setting. 2. Measurable disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 4. Adequate hematologic, renal, and hepatic functions 5. Patients must have \< Grade 2 pre-existing peripheral neuropathy (per National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v 4.03) 6. Life expectancy \> 3 months Exclusion Criteria: 1. Patients who have received any other investigational agents, chemotherapy, biologic therapy, or radiation therapy within the 28 days prior to Day 1 of the study. For investigational, chemotherapy, or biologic therapy, patients will be allowed on study if five half-lives or greater have elapsed since last dose of drug or 28 days, whichever is shorter. 2. Patients with prior taxane chemotherapy or agents which act by primary anti-angiogenic mechanisms. 3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit safety or compliance with study requirements or may interfere with the interpretation of the results. 4. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study initiation, or anticipation of need for major surgical procedure during the course of the study. 5. Evidence or history of uncontrolled hypertension, proteinuria, non-healing wound, ulcer, bone fracture, hemoptysis, valvular disease, abdominal fistula, GI perforation, intra-abdominal abscess, bleeding diathesis or coagulopathy that would exclude patients from treatment with anti-angiogenesis agents. 6. Therapeutic anticoagulation with coumarin-derivatives will not be permitted. However, a maximum daily dose of 1 mg will be permitted for port line patency. Anticoagulation with low molecular weight heparin or anti-Factor Xa agents will be allowed. 7. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise safety of treatment as so judged by treating physician (i.e., severely impaired lung function, severe infection, ventricular arrhythmias active ischemic heart disease, known active vasculitis of any cause, chronic liver or renal disease).

Study Objectives The purpose of this study was to examine the relationship between indices of overall diet quality and incident breast cancer risk in a large prospective cohort of women. Conditions: Invasive Breast Cancer, Incident Breast Cancer Intervention / Treatment: Location: Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Participants with no history of cancer diagnosis prior to baseline. * Participants with no history of myocardial infarction prior to baseline. * Participants with no history of stroke prior to baseline. * Participants with no history of diabetes prior to baseline. * Participants who are not missing excessive dietary data. * Participants with energy intake values at ≥1% and ≤99% of the population distribution.

Study Objectives The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy (pembrolizumab/chemotherapy) is safe and useful for patients with lung cancer. The study also will assess if the NEO-PV-01 vaccine, when given together with pembrolizumab and chemotherapy, can improve your response compared with pembrolizumab and chemotherapy treatment alone. All eligible patients will receive NEO-PV-01 + Adjuvant, pembrolizumab and chemotherapy while on this trial. Conditions: Carcinoma, Non-Small-Cell Lung, Lung Cancer, Nonsquamous Nonsmall Cell Neoplasm of Lung Intervention / Treatment: BIOLOGICAL: NEO-PV-01, BIOLOGICAL: Pembrolizumab, OTHER: Adjuvant, DRUG: Carboplatin, DRUG: Pemetrexed 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: * Willing and able to give written informed consent. * Have histologically confirmed unresectable or metastatic nonsquamous NSCLC and having received no prior systemic therapy for metastatic disease. * Have at least 1 site of disease measurable by RECIST v1.1 that has not been treated with local therapy within 6 months of study treatment. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. * At least 1 site of disease must be accessible to provide repeat biopsies for tumor tissue for sequence and immunological analysis. This site may be a target lesion as long as it will not be made unmeasurable by the biopsy procedure. * Have ECOG PS of 0 or 1 with an anticipated life expectancy of \> 6 months. * Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicities see below limits for inclusion) or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, Grade of 0 or 1, except for toxicities not considered a safety risk (eg, alopecia or vitiligo). * Screening laboratory values must meet the following criteria and should be obtained within 30 days (or 45 days if a biopsy is repeated) prior to study treatment: 1. White blood cell (WBC) count ≥ 3 × 10e3/µL 2. Absolute neutrophil count (ANC) ≥ 1.5 × 10e3/µL 3. Platelet count ≥ 100 × 10e3/µL 4. Hemoglobin \> 9 g/dL 5. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 40 mL/min/1.73 m2 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN for patients with liver metastases 7. Total bilirubin ≤ 1.5 × ULN (except in patients with Gilbert Syndrome who can have total bilirubin \< 3.0 mg/dL). Direct bilirubin ≤ ULN for patients with total bilirubin levels \>1.5 × ULN. 8. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants 9. Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants * Female patients of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Female patients of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 6.4.5.3, for the course of the study through 120 days after the last dose of study medication. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient. * Male patients of childbearing potential must agree to use an adequate method of contraception as outlined in Section 6.4.5.3, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient. Exclusion Criteria: * Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of first dose of treatment. * Received any systemic therapy for cancer treatment including immunotherapeutic agents such as anti-PD1 or anti-PD-L1 antibody therapy. * Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. * Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 30 days prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. 1. Note: Subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study. 2. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy * Patients may not receive or have received any radiation therapy at the biopsy sites. * Received radiation therapy to the lung \> 30 Gy within 6 months of first dose of study treatment. * Received prior tyrosine kinase inhibitor therapy or palliative radiation within 7 days of first dose of study treatment. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging (using the identical imaging modality for each assessment, either MRI or CT scan) for at least 4 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. * Patients may not receive any non-oncology vaccine therapy during the period of NEO PV-01 or pembrolizumab administration and until at least 8 weeks after the last dose of the booster vaccine. Seasonal influenza vaccines are allowed but may not be administered between the first dose of pembrolizumab and the last booster dose of NEO-PV-01 * Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 4 weeks prior to study Day 1. * Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor. * Received a live-virus vaccination within 30 days of planned treatment start. * Have symptomatic ascites or pleural effusion. * Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Has a history of interstitial lung disease. * Has an active infection requiring systemic therapy. * Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). * Have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia. * Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs. * Have a planned major surgery. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. * Nursing women are excluded from this study because there is an unknown but potential risk of AEs in nursing infants secondary to treatment of the mother with pembrolizumab, personalized neoantigen peptides, and adjuvant. * Have a history of an invasive metastatic disease, except for the following: 1. Individuals with a history of invasive metastatic disease are eligible if they have been disease free for at least 2 years and are deemed by the Investigator to be at low risk for recurrence of that metastatic disease; 2. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Patients with nonsquamous NSCLC having functionally significant anaplastic lymphoma kinase (ALK) translocations or epidermal growth factor receptor (EGFR) mutations who have not received prior treatment with ALK or EGFR inhibitor. * Have severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.

Study Objectives The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent. Conditions: Lymphoma Intervention / Treatment: DRUG: Nivolumab Location: Belgium, Germany, United States, Singapore, Norway, Canada, Australia, Spain, France, United Kingdom, Sweden, Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Grade 1, 2, or 3a FL without pathologic evidence of transformation * Male and female, ages 18 and above, with relapsed or refractory FL lymphoma after \> or =2 prior treatment lines; each of the 2 prior treatment lines must include at least CD20 antibody and/or an alkylating agent * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 Exclusion Criteria: * Known central nervous system lymphoma * History of interstitial lung disease * Subjects with active, known or suspected autoimmune disease * Prior allogeneic stem cell transplant * Prior autologous stem cell transplant ≤12 weeks prior to first dose of study drug

Study Objectives This is an open label, single arm dose escalation study of BBI503 in adult patients with advanced solid tumors. Conditions: Cancer, Advanced Solid Tumors Intervention / Treatment: DRUG: BBI503 Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: 1. Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures 2. A histologically or cytologically confirmed solid tumor that is metastatic, unresectable, or recurrent and for which standard curative or palliative therapies do not exist or are no longer effective. 3. ≥ 18 years of age 4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 5. Karnofsky performance status ≥ 70% 6. 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 BBI503 dose 7. Females of childbearing potential must have a negative serum pregnancy test 8. Aspartate transaminase (AST) and alanine transaminase (ALT) \< or equal to 1.5 × upper limit of normal (ULN) 9. Hemoglobin (Hgb) ≥ 10 g/dl 10. Total bilirubin \< or equal to 1.5 × ULN 11. Creatinine \< or equal to 1.5 x ULN or creatinine clearance \> 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal 12. Absolute neutrophil count \< or equal to 1.5 x 10\^9/L 13. Platelets ≥ 100 x 10\^9/L 14. Life expectancy ≥ 3 months Exclusion Criteria: 1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before beginning the administration of BBI503 2. Surgery within 4 weeks prior to first dose 3. Any known untreated brain metastases. Treated subjects must be stable for 4 weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated. 4. Pregnant or breastfeeding 5. Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection and small intestinal resection) 6. Unable or unwilling to swallow BBI503 capsules daily 7. Uncontrolled intercurrent 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 mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements

Study Objectives This phase I study will evaluate the safety and tolerability of an autologous idiotype vaccine manufactured by magnICON technology for patients with relapsed follicular lymphoma who are in complete or partial remission following non-antiCD20 containing salvage therapy. Data in terms of idiotype-specific immune responses will also be obtained. Conditions: Lymphoma, Follicular Intervention / Treatment: BIOLOGICAL: Autologous FL vaccine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Subjects with histologically proven follicular lymphoma (grade 1, 2, or 3a), in clinical relapse/progression requiring treatment * Subjects must have had first line treatment consisting of rituximab with or without rituximab maintenance therapy (i.e. rituximab monotherapy, R-CHOP, R-CVP, R-FND, etc) * At least 4 months since last rituximab exposure * Subjects may have had any number of prior treatment regimens. If enrolled with transformed follicular lymphoma, study subject must have had anthracycline in a previous regimen * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Life expectancy of at least 12 months * Presence of at least a 2x2 cm in diameter lymph node (either a single lymph node or combined volume of lymphoid tissue) accessible for excision; for histological confirmation of diagnosis and for manufacture of the vaccine * Measurable disease in neck, chest, abdomen, or pelvis as assessed by computed tomography (CT) scan such that response to 2nd line chemotherapy can be defined by the criteria of Cheson et al (JCO 2007; 25:579, see appendix 15.2 and ref 65). PET scan results are not required for enrollment Exclusion Criteria: * Exposure to rituximab or antiCD-20 directed therapy within the 4 months prior to enrollment * History of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection * Active clinically serious infections (\> grade 2 National Cancer Institute Common Toxic Criteria \[NCI-CTC\] version 3.0) * Symptomatic metastatic brain or meningeal tumors including lymphoma unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry * History of organ allograft * Patients undergoing renal dialysis

Study Objectives Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled, double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis Complex who are less than 6 months of age prior to the onset of their first seizure Conditions: Tuberous Sclerosis Complex Intervention / Treatment: DRUG: Vigabatrin, DRUG: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: 1. less than or equal to 6 months of age 2. No history of seizures or infantile spasms, or evidence of subclinical electrographic seizures on a previous video EEG 3. Meet genetic or clinical diagnostic criteria for TSC, the latter based on current recommendations for diagnostic evaluation, such as physical exam, neuroimaging, echocardiogram Exclusion Criteria: 1. Is greater than 6 months of age 2. Has not been diagnosed with TSC 3. History of seizures or infantile spasms, or evidence of subclinical electrographic seizures on a previous video EEG 4. Has received any anticonvulsant medication including vigabatrin, other anti-seizure therapeutic agent including cannabidiol 5. Has received an oral mTOR inhibitor such as everolimus or sirolimus 6. Has taken an investigational drug, including but not limited to cannabidiol, as part of a research study 30 days prior to enrollment, or plans on taking an investigational drug at any time during the duration of the study 7. Is currently enrolled, or plans on enrolling at any time during the duration of the study, in an experimental behavioral early intervention study 8. Has a history of being born prematurely (born less than \<30 weeks gestation at the time of delivery)

Study Objectives RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if surgery plus combination chemotherapy is more effective than surgery alone for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have non-small cell lung cancer. Conditions: Lung Cancer Intervention / Treatment: DRUG: carboplatin, DRUG: paclitaxel, PROCEDURE: conventional surgery Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

DISEASE CHARACTERISTICS: * Histologically or cytologically proven non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria: * Stage IB (T2, N0) * Stage II * T1-2, N1 with negative mediastinoscopy OR * T3, N0 * Selected stage IIIA with negative mediastinoscopies * T3, N1, excluding superior sulcus * Positive level 10 hilar nodes allowed if mediastinoscopy negative * Apical tumors with no clinical symptoms allowed * No symptomatic tumors (T3, N0 or T3, N1) involving the superior sulcus * No Pancoast's tumors * Negative mediastinoscopy required in all patients with clinically positive mediastinal or hilar lymph nodes to ensure no N2 disease * Bidimensionally measurable or evaluable disease by chest x-ray or contrast-enhanced CT scan * T3, N0 disease assessable only by bronchoscopy must be affirmed by 2 observers and documented by photograph that includes main carina PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0 or 1 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * WBC at least 4,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT or SGPT no greater than 2 times ULN * Alkaline phosphatase no greater than 2 times ULN Renal: * Creatinine no greater than 1.5 times ULN * Creatinine clearance at least 50 mL/min Pulmonary: * See Disease Characteristics * Preresection FEV_1 greater than 2.0 L OR * Predicted postresection FEV_1 greater than 1.0 L * No postobstructive pneumonia Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serious infection * No other serious medical condition that would preclude study compliance * No prior allergic reactions to drugs containing Cremophor * No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior systemic chemotherapy for NSCLC * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior systemic radiotherapy for NSCLC * No concurrent radiotherapy Surgery: * At least 5 years since prior resection of lung disease Other: * No other concurrent investigational therapy * No other concurrent anticancer therapy

Study Objectives The strategy for combining therapeutic agents in cancer treatments has been successful in multiple tumor types, including NSCLC. Erlotinib and bevacizumab target different pathways involved in tumor growth. Nonclinical studies have demonstrated that the combination of bevacizumab and erlotinib results in greater efficacy than either agent alone. Furthermore, because there is little to no overlap in toxicity profile between the two agents, the combination is expected to be well tolerated and may provide even greater benefit for patients who are unable to receive cytotoxic therapy. Conditions: Lung Cancer Intervention / Treatment: DRUG: Erlotinib, DRUG: Bevacizumab 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: * Histological proof of non-small cell lung cancer meeting one of the following criteria: * stage III b with a pleural effusion * stage IV * Histology must not be squamous cell. * No prior chemotherapy or hormonal therapy. * Prior radiation therapy must be completed at least 21 days prior to being registered for protocol therapy. * No prior use of an epidermal growth factor receptor (EGFR) inhibitor or antiangiogenic agent. * No treatment with any investigational agent within 30 days prior to being registered for protocol therapy. * Measurable disease according to RECIST and obtained by imaging within 28 days prior to being registered for protocol therapy. * ECOG Performance Status of 2 in the opinion of the treating investigator. * Age \> 18 years at the time of consent. * Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for a 6 week period thereafter. * Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. * Females must not be breastfeeding. * Able to comply with study and/or follow-up procedures. Exclusion Criteria: * Evidence of bleeding diathesis or coagulopathy. * Evidence of central nervous system involvement or brain metastases confirmed by head CT or brain MRI within 28 days prior to being registered for protocol therapy. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy. * Anticipation of need for major surgical procedure during the course of the study. * Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy. * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for protocol therapy. * Serious, non-healing wound, ulcer, or bone fracture. * History of hemoptysis. * Clinically significant infections as judged by the treating investigator. * Other active malignancy

Study Objectives To evaluate the safety (adverse events and dose-limiting toxicity) of daily oral doses of ZSTK474 in patients with advanced solid malignancies. Conditions: Neoplasms Intervention / Treatment: DRUG: ZSTK474 Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Japanese males or females \>= 20 years old * Advanced (metastatic or unresectable) solid tumor * ECOG performance status score of 0 or 1 and expected survival \>12 weeks * Recovered from hematological toxicities of prior cancer therapies Exclusion Criteria: * Previous treatment with PI3K inhibitor * Serious/significant illnesses or underlying conditions, including diabetes or hepatic renal or CV disease. * Other investigational agent within previous 4 weeks * Participating in another clinical study

Study Objectives The proposed two stage study will evaluate patterns of local recurrence after EBRT and brachytherapy in spatial reference to baseline functional MRI and FLT/F-Miso PET scan in patients undergoing chemoradiotherapy for postoperative recurrences of cervical cancer. The first stage of the study will focus on developing MR guided interstitial brachytherapy and validating the concept of high risk gross tumor volume (on the basis of functional imaging features). The second stage thereafter will focus on developing biologically modulated interstitial brachytherapy. In the proposed two staged study the investigators intend to prospectively evaluate and validate concept of HRGTV and develop technique of biologically dose modulated brachytherapy. The demonstration of technical feasibility and clinical safety of biologically modulated image guided radiotherapy in this pilot study for may pave the way for improving local control in patients with postoperative recurrences. Conditions: Cervical Cancer Intervention / Treatment: RADIATION: MR PET Guided Brachytherapy Location: India Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age \> 18 years. * ECOG 0 or 1. * Residual/ Recurrent tumor after hysterectomy of cervical cancer. * No visceral metastasis. * No known contraindication to contrast enhanced MRI/PET scan. * Fit for radical treatment (radiotherapy+/-chemotherapy). Exclusion Criteria: * Expected survival less than 3 years due to coexisting morbid medical conditions precluding radical chemoradiotherapy. * Inguinal or extra-pelvic nodal metastasis (Patients with common iliac nodal enlargement in the absence of paraaortic nodal metastasis on PET-CT may be included in the study).

Study Objectives Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia in blastic phase Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Blastic Phase Chronic Myelogenous Leukemia, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Excess Blasts in Transformation, Relapsing Chronic Myelogenous Leukemia, Secondary Myelodysplastic Syndromes Intervention / Treatment: DRUG: temsirolimus, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Diagnosis of 1 of the following: * Acute myeloid leukemia * Acute lymphoblastic leukemia * Myelodysplastic syndromes * Refractory anemia with excess blasts \[RAEB\] * RAEB in transformation * Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood/bone marrow blasts * Chronic myelogenous leukemia in blastic phase * Disease status must meet 1 of the following criteria: * Primary resistant disease (i.e., failed to achieve a complete response \[CR\] to a prior standard induction regimen) * Relapsed disease after achieving a CR * Documented failure to most recent cytotoxic regimen * No other potentially curative options * No known CNS disease * Performance status - ECOG 0-2 * SGOT or SGPT \< 3 times upper limit of normal\* * Bilirubin ≤ 2 mg/dL\* * Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement) * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reaction attributed to compounds of similar chemical or biological composition to CCI-779 * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No AIDS-defining disease * HIV positive allowed if CD4 counts normal * No other concurrent uncontrolled illness * No concurrent prophylactic hematopoietic colony-stimulating factors * More than 2 weeks since prior cytotoxic chemotherapy (except hydroxyurea) and recovered * More than 2 weeks since prior radiotherapy and recovered * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents * No other concurrent anticancer agents or therapies

Study Objectives Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens that result in periods of profound neutropenia leaving patients susceptible to severe infectious complications. Infectious complications are the leading cause of treatment related mortality among AML patients, but there are little clinical data to inform whether management of neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting. The primary objective of this study is to compare the clinical effectiveness of outpatient versus inpatient management of neutropenia in children with AML. Conditions: Acute Myeloid Leukemia, Neutropenia, Bacteremia Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: 1. Males or females of age less than 19 at diagnosis. 2. Receipt or planned receipt of AML chemotherapy between January 1, 2012 and December 31, 2019. Exclusion Criteria: 1. Patients being treated for relapsed AML 2. Patients with Acute Promyelocytic Leukemia (APML) 3. Patients undergoing stem cell transplant (SCT) 4. Patients receiving reduced intensity frontline chemotherapy

Study Objectives The trial is designed as a randomised, controlled, open, parallel group, multi-centre phase II trial to evaluate clinical efficacy of selinexor in combination with cyclophosphamide and prednisone. Conditions: Relapsed or Refractory Multiple Myeloma Intervention / Treatment: DRUG: Selinexor, DRUG: Cyclophosphamide, DRUG: Prednisone Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: 1. Able to give informed consent and willing to follow all trial protocol assessments 2. Aged 18 years or over 3. Participants with confirmed myeloma based on International Myeloma Working Group (IMWG) criteria (Rajkumar et al. (2014)) 4. Measurable disease with at least one of the following: * Paraprotein ≥5g/L * Serum free light chains ≥100mg/L with abnormal ratio for light chain only myeloma * Bence Jones protein ≥200mg/L 5. Participants with relapsed or relapsed refractory myeloma who have received ≥ 2 prior anti-myeloma treatments including a proteasome inhibitor and lenalidomide, and now require further treatment 6. Patients for which cyclophosphamide and prednisone alone would be a suitable treatment 7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 8. Female participants of childbearing potential must agree to use two methods of contraception (including one highly effective and one effective method of contraception) and have a negative urine pregnancy test at screening. Male participants must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female participants, effective methods of contraception must be used throughout the trial and for at least 36 months following the last dose of trial treatment 9. Required laboratory values within 14 days prior to randomisation: * Platelet count ≥50x109/L. Platelet count of 30-50 is acceptable if bone marrow aspirate or trephine shows tumour replacement of \>50%. Platelet support is permitted within 14 days prior to randomisation, although platelet transfusions to help participants meet eligibility criteria are not allowed within 72 hours prior to the blood sample to confirm protocol eligibility * Absolute neutrophil count ≥1.0 x 109/L. Growth factor support is not permitted within 14 days prior to randomisation * Haemoglobin ≥ 8090 g/L. Blood support is permitted * Alanine transaminase (ALT) and / or aspartate transaminase (AST) ≤3 x upper limit of normal * Creatinine clearance ≥ 2030 ml/min (using Cockcroft Gault formula) * Bilirubin ≤1.5 x upper limit of normal . Gilberts syndrome patients must have a total bilirubin ≤3 x upper limit of normal Exclusion Criteria: 1. The following participants will be excluded: * those with non-measurable disease * those with a solitary bone or solitary extramedullary plasmacytoma * plasma cell leukaemia 2. Participants with a history of malignancy (other than myeloma) within 5 years before the date of randomisation (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that, in the opinion of the investigator, with concurrence with the Chief Investigator, is considered cured with minimal risk of recurrence within 5 years) 3. Participants with a known or underlying uncontrolled concurrent illness that, in the investigator's opinion, would make the administration of the trial drug hazardous or circumstances that could limit compliance with the trial, including, but not limited to the following: * acute or chronic graft versus host disease * uncontrolled hypertension * symptomatic congestive heart failure * unstable angina pectoris * myocardial infarction within past 6 months * uncontrolled cardiac arrhythmia (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version 4 GradeCTCAE grade ≥2) * active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B or C) hepatitis * psychiatric or social conditions that may interfere with participant compliance * uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral * or any other condition (including laboratory abnormalities) that in the opinion of the Investigator places the participant at unacceptable risk for adverse outcome if he/she were to participate in the trial 4. Participants who have previously received Selinexor or any other SINE compound 5. Previous anti-tumour therapies including investigational medicinal products at any dose within 28 days before the start of protocol treatment. * Prednisone up to a dose of 175 mg per week may be given between screening and the beginning of treatment if medically required but should be stopped before trial treatment starts. * Bisphosphonates for bone disease are also permitted 6. Participants with a history of a refractory nausea, diarrhoea, vomiting, malabsorption, gastrointestinal surgery or other procedures or conditions that might, in the opinion of the Investigator, interfere with the absorption or swallowing of the trial drug(s) 7. Peripheral neuropathy of CTCAE grade ≥ grade 32 (or ≥ grade 21 with pain) severity (as per NCI-CTCAEv4.0 ) 8. Female participants who are lactating or have a positive pregnancy test at screening 9. Known allergy or previous intolerance to any of the trial medications, their analogues, or excipients in the various formulations of any agent that would prevent the participant receiving these as directed in the protocol 10. Major surgery within 14 days prior to randomisation 11. Radiotherapy within 7 days prior to randomisation for palliative pain control or therapeutic radiotherapy within 14 days prior to randomisation 12. Chemotherapy or immunotherapy or any other anticancer therapy within 2 weeks prior to Cycle 1 Day 1 or radio-immunotherapy 4 weeks prior to Cycle 1 Day 1 (NB: except steroids in the doses outlined above) 13. Myeloma involving the Central Nervous System SCP following CP Inclusion Criteria 1. Randomised to CP on the MUKtwelve trial, has tolerated treatment and can continue on CP during the SCP treatment, and received at least one full cycle of treatment 2. Centrally confirmed disease progression by IMWG criteria. This must be confirmed by two consecutive assessments based on local lab results. Local laboratory reports must be sent to CTRU to confirm progression and site must have received confirmation of progression from CTRU. 3. ECOG performance status ≤2 4. Required laboratory values within 14 days prior to starting treatment on SCP: * Platelet count ≥50x109/L. Platelet count of 30-50 is acceptable if bone marrow aspirate or trephine shows tumour replacement of \>50%. Platelet support is permitted within 14 days prior to starting SCP, although platelet transfusions to help participants meet eligibility criteria are not allowed within 72 hours prior to the blood sample to confirm protocol eligibility * Absolute neutrophil count ≥1.0 x 109/L. * Haemoglobin ≥ 80 g/L. Blood support is permitted * Alanine transaminase (ALT) and / or aspartate transaminase (AST) ≤3 x upper limit of normal * Creatinine clearance ≥ 20 ml/min (using Cockcroft Gault formula) * Bilirubin ≤1.5 x upper limit of normal. Suspected Gilberts syndrome patients must have a total bilirubin ≤3 x upper limit of normal * B2M 5. Female participants of childbearing potential must agree to use two methods of contraception (including one highly effective and one effective method of contraception) and have a negative urine pregnancy test at screening. Male participants must use an effective barrier method of contraception if sexually active with a female of childbearing potential. For both male and female participants, effective methods of contraception must be used throughout the trial and for 12 months following the last dose of trial treatment

Study Objectives Background: Adult T-cell leukemia/lymphoma (ATLL) and mycosis fungoides/Sezary syndrome (MF/SS) are cancers that form in the T cells, a type of white blood cell that helps with the body's immune response. A combination of drugs might be able to better treat these cancers than existing therapies. Objective: To test if the drugs interleukin-15 (IL-15) and mogamulizumab are safe and effective to treat people with Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome (ATLL or MF/SS). Eligibility: People ages 18 and older with relapsed ATLL or MF/SS that has not responded to at least one standard treatment Design: Participants will be screened with: Medical history Physical exam Blood (including human immunodeficiency virus (HIV), hepatitis B and C), urine, lung, and heart tests Bone marrow tests (if needed): A needle inserted in the participants hip will take a small amount of marrow. Computed tomography (CT), positron emission tomography (PET) and/or magnetic resonance imaging (MRI) scans Tumor biopsy (if needed): A needle will take out a small piece of the participants tumor. Participants will get the study drugs by vein for up to six 28-day cycles. They will get IL-15 the first 5 days of each cycle. They will get mogamulizumab on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of the other cycles. They will be hospitalized for 1 week in cycle 1. They may need to get a midline catheter. This is a soft tube put into a vein leading to the heart. Participants will have repeats of the screening tests throughout the study. After treatment, participants will have visits every 60 days for 6 months, every 90 days for 2 years, and then every 6 months for 2 years. Conditions: Adult T-Cell Lymphoma/Leukemia, Sezary Syndrome, Mycosis Fungoides Intervention / Treatment: DRUG: Recombinant human Interleukin-15 (rhIL-15), BIOLOGICAL: Mogamulizumab 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: 1. Patients must have one of the following histologically or cytologically proven relapsed and/or refractory to at least one line of systemic treatment, T-cell malignancies confirmed by the Laboratory of Pathology, National Cancer Institute (NCI): mycosis fungoides/Sezary syndrome, or adult T-cell leukemia (chronic, acute, or lymphoma subtype by Shimoyama criteria) 2. Patients with luster of differentiation 30 (CD30)+ Mycosis Fungoides/Sezary Syndrome (MF/SS) must have relapsed after or become intolerant to treatment with brentuximab vedotin 3. A formalin fixed tissue block or 15 slides of tumor sample (archival or fresh) must be available for performance of correlative studies. NOTE: Patients must be willing to have a tumor biopsy if prior tissue or adequate archival tissue is not available (i.e., post- enrollment and prior to treatment). 4. Disease must be measurable with at least one measurable lesion by Response Evaluation Criteria in Lymphoma (RECIL 2017) or modified severity-weighted assessment tool (mSWAT) criteria, or have an abnormal clonal T-cell population detectable by peripheral blood flow cytometry 5. Age \>18 years NOTE: Because no dosing or adverse event data are currently available on the use of rhIL-15 in combination with mogamulizumab in patients \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials 6. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 (Karnofsky greater than or equal to 80% 7. Patients must have normal organ and marrow function as defined below: * Absolute neutrophil count: greater than or equal to 1,000/mcL * Platelets: \> 100,000/mcL * Total bilirubin: less than or equal to 1.5 X institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST)Serum glutamic oxaloacetic transaminase (SGOT)/Alanine aminotransferase (ALT)Serum glutamic pyruvic transaminase (SGPT): less than or equal to 2.5 X institutional ULN * Serum creatinine: less than or equal to 1.5 X institutional ULN, OR Creatinine clearance: greater than or equal to 50 mL/min/1.73 m2 for patients with creatinine levels \>1.5 institutional ULN 8. Negative serum or urine pregnancy test at screening for women of childbearing potential (WOCBP) NOTE: WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. 9. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 6 months after completion of rhIL-15 and mogamulizumab administration. 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. 10. Ability of subject to understand and the willingness to sign a written informed consent document EXCLUSION CRITERIA: 1. Patients with other T-cell leukemias/lymphomas not specified in the inclusion criteria 2. Anti-cancer treatment within 2 weeks of the first dose of rhIL-15 and mogamulizumab (4 weeks for anti-cancer monoclonal antibody or investigational agents, 6 weeks for donor lymphocyte infusion,100 days for allogeneic stem cell transplant) 3. Systemic treatment for acute or chronic graft versus host disease (GVHD) within 12 weeks of the first dose of rhIL-15 and mogamulizumab 4. Cohort 1 (Dose Escalation) only: history of grade 3/4 GVHD, or active grade 1/2 GVHD regardless of treatment 5. Persisting toxicity related to prior therapy of grade \> 1, with the exception of the following: alopecia, sensory neuropathy grade less than or equal to 2, or other grade less than or equal to 2 not constituting a safety risk based on investigator's judgment 6. Patients who are receiving any other investigational agents 7. Current use of immunosuppressive medication, EXCEPT for the following: * Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection) * Systemic corticosteroids at physiologic doses less than or equal to 10 mg/day of prednisone or equivalent; or, * Steroids as premedication for hypersensitivity reactions (e.g., computed tomography (CT) scan premedication) 8. Patients with previous malignant disease other than the target malignancy within the last 3 years with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ 9. Cohort 1 (Dose Escalation) only: Active or history of any autoimmune disease thought to be unrelated to their malignancy; for Cohort 2 (Dose Expansion), patients with history of autoimmune disease who are not on active immunosuppressive therapy 10. Patients with asthma requiring chronic inhaled or oral corticosteroids, or history of asthma requiring mechanical ventilation. Patients with a history of mild asthma that are on or can be switched to non-corticosteroid bronchodilator regimens are eligible 11. Patients with active bacterial infections, documented human immunodeficiency virus (HIV) infection or positive HIV 1/2 antibodies at screening, polymerase chain reaction (PCR) evidence for active or chronic hepatitis B or hepatitis C, or positive screening hepatitis B virus (HBV)/hepatitis C virus (HCV) serology without documentation of successful curative treatment 12. Presence of uncontrolled intercurrent illnesses including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, cognitive impairment, active substance abuse, or psychiatric illness/social situations that in the view of the Investigator would preclude safe treatment and limit compliance with study requirements 13. Inability or refusal to practice effective contraception during therapy or the presence of pregnancy or active breastfeeding. Because there is no significant preclinical information regarding the risks to a fetus or a newborn infant, all pregnant or breastfeeding woman will be excluded from participation in this trial 14. History of allergic reactions attributed to compounds of similar chemical or biologic composition to rhIL-15 or mogamulizumab, unless felt to be in the best interests of the patient in the opinion of the investigator 15. Patients who received a live vaccine within 30 days of planned start of study therapy. Vaccination with a live vaccine while on trial is prohibited. 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

Study Objectives The goal of this clinical research study is to learn if giving busulfan and fludarabine before a stem cell transplant can help control the disease better than the standard method in patients with leukemia, lymphoma, multiple myeloma, MDS, or MPD. In this study, 2 doses of busulfan will be given 2 weeks before a stem cell transplant followed by 4 doses of busulfan and fludarabine during the week before the stem cell transplant, rather than the standard method of giving 4 doses of busulfan and fludarabine only during the week before the stem cell transplant. The safety of this combination therapy will also be studied. Busulfan is designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die. Busulfan is commonly used in stem cell transplants. Fludarabine is designed to interfere with the DNA of cancer cells, which may cause the cancer cells to die. Conditions: Leukemia, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myeloproliferative Diseases, Non-Hodgkins Lymphoma, Hodgkins Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome Intervention / Treatment: DRUG: Fludarabine monophosphate, DRUG: Busulfan, PROCEDURE: Stem Cell Infusion, DRUG: Tacrolimus, DRUG: Methotrexate, DRUG: G-CSF 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: 1. Patients with high-risk hematologic malignancies with anticipated poor prognosis with non transplant therapy, including those in remission or with induction failure and after treated or untreated relapse. Diagnoses to be included a) Acute myeloid leukemia; b) Acute lymphocytic leukemia; c) Chronic myeloid leukemia; d) Chronic lymphocytic leukemia; e) Myelodysplastic syndrome; f) Myeloproliferative syndromes; g) Non-Hodgkins lymphoma; h) Hodgkins Lymphoma; i) Multiple myeloma. 2. Patients must have a histocompatible stem cell donor. An HLA-identical related donor or a 8/8 matched unrelated donor. 3. Age 5 to 75 years old. 4. Performance score of \>/= 70 by Karnofsky/Lansky or PS 0 to 1 (ECOG \</=1). 5. Left ventricular ejection fraction at least 40%. 6. Adequate pulmonary function with FEV1, FVC and DLCO \>/=50% of expected corrected for hemoglobin and/or volume. Children unable to perform pulmonary function tests (e.g., less than 7 years old) pulse oximetry of \>/= 92% on room air 7. Creatinine clearance (calculated creatinine clearance is permitted) should be \>40 ml/min. 8. Bilirubin \</= 2 x the upper limit of normal (except Gilbert's Syndrome). SGPT (ALT) \< 200. 9. Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of child bearing potential must be willing to use an effective contraceptive measure while on study. 10. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent. Exclusion Criteria: 1. HIV seropositivity. 2. Uncontrolled infections.

Study Objectives Patient decision aids are tools that help guide individuals through a healthcare-related decision making process. They help users combine evidence-based information and recommendations by a health care provider with their personal needs, values and preferences. Through this project, Dr. Dobbins and her research team will explore whether the use of patient decision aids with high-quality and user-friendly summaries of research evidence, or summaries of research evidence alone, help to improve the quality of decision making by women facing breast cancer screening decisions. Conditions: Breast Cancer Intervention / Treatment: OTHER: Evidence-based information, BEHAVIORAL: Patient Decision Aid, OTHER: Sham information Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SCREENING Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * English speaking women, 40-49 years old * Residents of British Columbia, Nova Scotia, and Prince Edward Island Exclusion Criteria: * History of breast cancer or mammography in the last 12 months * Classified as above-average risk for breast cancer (i.e., known genetic mutation linked to BC; no genetic testing, but a parent, sibling or child with a genetic mutation linked to BC; or received chest wall radiation before age 30)

Study Objectives RATIONALE: New diagnostic procedures, such as contrast-enhanced ultrasonography, may be an effective method of finding ovarian cancer. PURPOSE: This clinical trial is studying how well contrast-enhanced ultrasonography works in diagnosing early-stage ovarian cancer in patients with an adnexal mass undergoing surgery to remove the ovary. Conditions: Ovarian Cancer Intervention / Treatment: DRUG: Definity, OTHER: medical chart review Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: * Diagnosis of adnexal mass * Scheduled to undergo surgical oophorectomy PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * No known respiratory failure as manifested by signs and symptoms of carbon dioxide retention or hypoxemia * No pulmonary vasculitis * No known history of severe emphysema * No known history of pulmonary emboli * No other condition that causes pulmonary hypertension due to compromised pulmonary arterial vasculature * No known history of severe pulmonary hypertension (i.e., systolic pulmonary artery pressures \> 90 mm Hg) * No known history of congenital heart defect that creates a bidirectional or right-to-left shunt * No worsening or clinically unstable congestive heart failure * No known acute myocardial infarction or acute coronary syndromes * No known serious ventricular arrhythmias * Not at high risk for arrhythmia due to prolongation of the QT interval * No known or suspected hypersensitivity to blood, blood products, or albumin * No known hypersensitivity to perflutren * No known or suspected hypersensitivity to octafluoropropane or any other ingredients of perflutren lipid microspheres (Definity®) * No mental status problems, illiteracy, or other circumstance that would preclude giving informed consent PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Study Objectives This pilot clinical trial studies mechanically-manipulated ultrasound in finding tumors during robotic-assisted surgery in patients with prostate cancer. Diagnostic procedures, such as ultrasound, may help find prostate cancer and find out how far the disease has spread during surgery Conditions: Prostate Cancer Intervention / Treatment: PROCEDURE: ultrasound imaging, PROCEDURE: robot-assisted laparoscopic surgery Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Undergoing Robotic Assisted Laparoscopic Prostatectomy Exclusion Criteria: * Known or discovered rectal pathology * Bleeding hemorrhoids * Rectal stenosis * Any prior rectal surgeries * Prior rectal radiation * Any known rectal disease

Study Objectives The purpose of this study is to investigate the safety and efficacy of simultaneous liver resections compared to staged hepatectomies of rectal cancer with liver metastasis and to compare the short and long-term survival between the two groups. Conditions: Rectal Neoplasm With Metastasis to the Liver Intervention / Treatment: PROCEDURE: simultaneous resection of liver metastasis and the rectal primary tumor, PROCEDURE: staged resection of liver metastasis and the rectal primary tumor Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * age\>=18 and \<= 75 years * resectable primary rectal tumor * remnant liver volume \>= 60% * without other organ metastasis or peritoneum metastasis * without contradiction of cardiac and pulmonary diseases * American Society of Anesthesiologists (ASA) class I - II * Histologically proved rectal adenocarcinoma Exclusion Criteria: * age \> 75 years * unresectable primary rectal tumor * remnant liver volume \< 60% * with other organ metastasis or peritoneum metastasis * with contradiction of cardiac and pulmonary diseases * Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy * Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery * Multiple colorectal tumors or other schedules needing for synchronous colon surgery * Co-existent inflammatory bowel disease * Pregnancy or lactation * Patients received treatment other than preoperative radio- or chemoradiotherapy

Study Objectives The purpose of this study is to determine within the scope of the trial what the maximum tolerated dose (MTD) of lenalidomide in combination with AVD should be. Conditions: Hodgkin Lymphoma Intervention / Treatment: DRUG: Doxorubicine, DRUG: DTIC, DRUG: Lenalidomide, DRUG: Vinblastine Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Hodgkin Lymphoma, intermediate or advanced stage * Age \>60 and \<75 years * ECOG 2 or better * No major organ dysfunction * Ability to take aspirin or LMW Heparin Exclusion Criteria: * HL as composite lymphoma * Prior use of lenalidomide * Prior use of chemo- or radiotherapy

Study Objectives LM3 is a novel somatostatin receptor antagonist, while Gallium-68 DOTATATE is a typical somatostatin receptor agonist, This study is to evaluate the safety, biodistribution, dosimetry, and lesion detection ability of Gallium-68 labeled somatostatin receptor antagonist LM3 for the diagnostic imaging of metastatic, well-differentiated neuroendocrine tumors using positron emission tomography / computed tomography (PET/CT). The results will be compared between antagonist Gallium-68 labeled LM3 and agonist Gallium-labeled DOTATATE in the same group of patients. It will also be compared between the two different antagonists, Gallium-68 DOTA-LM3 and Gallium-68 NODAGA-LM3, in two parallel-designed arms. Conditions: Neuroendocrine Tumors Intervention / Treatment: DIAGNOSTIC_TEST: Gallium-68 NODAGA-LM3 PET/CT, DIAGNOSTIC_TEST: Gallium-68 DOTA-LM3 PET/CT, DIAGNOSTIC_TEST: Gallium-68 DOTATATE PET/CT Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: DIAGNOSTIC Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Written informed consent. * Patients of either gender, aged ≥ 18 years. * Histologically confirmed diagnosis of Metastatic, well-differentiated neuroendocrine tumor. * A diagnostic computed tomography (CT) or magnetic resonance imaging (MRI) of the tumor region within the previous 6 months prior to dosing day is available. * At least 1 measurable lesion based on RECIST v1.1. * Blood test results as follows (White blood cell: ≥ 3\*10\^9/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x10\^9/L, Alanine aminotransferase / Aspartate aminotransferase / Alkaline phosphatase: ≤ 5 times upper limit od normal (ULN), Bilirubin: ≤ 3 times ULN) * Serum creatinine: within normal limits or \< 120 μmol/L for patients aged 60 years or older. * Calculated Glomerular filtration rate (GFR) ≥ 45 mL/min. Exclusion Criteria: * Known hypersensitivity to Gallium-68, to NODAGA, to DOTA, to LM3, to TATE or to any of the excipients of Gallium-68 DOTA-LM3, Gallium-68 NODAGA-LM3 or Gallium-68 DOTATATE. * Presence of active infection at screening or history of serious infection within the previous 6 weeks. * Therapeutic use of any somatostatin analog, including long-acting Sandostatin (within 28 days) and short-acting Sandostatin (within 2 days) prior to study imaging. If a patient is on long-acting Sandostatina, then a wash-out phase of 28 days is required before the injection of the study drug. If a patient is on short-acting Sandostatin, then a wash-out phase of 2 days is required before the injection of the study drug. * Any neuroendocrine tumor-specific treatment between antagonist and agonist scans. * Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study. * Pregnant or breast-feeding women. * Current history of any malignancy other than neuroendocrine tumor; patients with a secondary tumor in remission of \> 5 years can be included. * Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.

Study Objectives Pancreaticoduodenectomy (whipple procedure) is the standard operation for tumors of the pancreatic head, uncinate process, distal common bile duct as well as the papilla of vater. For reconstruction, pylorus-preservation (PPPD) has been shown to be technically and oncologically equivalent to the traditional whipple operation. One issue with this technique is delayed gastric emptying (DGE), which occurs in 25-70% of patients, usually emerging between day 4 and 14 after surgery. Patients with severe DGE can not only experience prolonged length of hospital stay, but are also at increased risk for other complications like aspiration or other issues related to the inability to ingest nutrition. There is vast retrospective evidence and one prospective study indicating that antecolic reconstruction of the duodenojejunostomy can improve the rate and severity of delayed gastric emptying. The investigators have conducted a prospective randomized trial in order to test this hypothesis. Patients were randomized to either undergo antecolic or retrocolic reconstruction after PPPD. On day 10 after surgery, DGE was assessed by clinical criteria. In addition, a test meal including 1g paracetamol was administered to check for clinically inapparent DGE. Of these serum samples, kinetics of intestinal peptides like GLP-1, PYY and glucagon was alos measured. Conditions: Pancreatic Cancer, Surgery, Improvement of Perioperative Outcome Intervention / Treatment: PROCEDURE: antecolic reconstruction, PROCEDURE: retrocolic reconstruction Location: Austria Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * verified cancer of the pancreatic head/neck/uncinate process or distal bile duct, radiographically suspicious tumor requiring pancreaticoduodenectomy * pylorus-preserving reconstruction planned * no evidence of distant metastases * written informed consent Exclusion Criteria: * age \<18 or \>90 years * status post surgical resection of stomach or duodenum * locally unresectable: * invasion of the hepatic artery/superior mesenteric artery * \>180 deg invasion of portal vein/superior mesenteric vein * gastric invasion * hypersensitivity to paracetamol * clinically significant anastomotic dehiscence * postoperative pancreatitis \> day 10 * preoperative evidence of gastroparesis

Study Objectives Phase I trial to study the effectiveness of BMS-214662 plus trastuzumab in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells Conditions: Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: BMS-214662, BIOLOGICAL: trastuzumab, OTHER: pharmacological study 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 or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective therapy exists * Overexpressing HER-2-neu (2+ or 3+) by immunohistochemistry or fluorescent in situ hybridization * Clinically or radiologically evaluable disease * No carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease * At least 8 weeks since prior therapy for prior brain parenchymal disease and asymptomatic off corticosteroids * Performance status - ECOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.8 mg/dL * ALT and AST no greater than 1.5 times upper limit of normal (ULN) * Creatinine no greater than 1.5 times ULN * No uncontrolled or significant cardiovascular disease * No myocardial infarction within the past 6 months * No prior clinically significant atrial or ventricular arrhythmias * No prior second or third degree heart block * No ischemic heart disease requiring medication * No congestive heart failure * Corrected QT interval no greater than 450 milliseconds by electrocardiogram * Ejection fraction at least lower limit of normal by MUGA scan * No uncontrolled or significant pulmonary disease * No active unresolved infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study * At least 4 weeks since prior immunotherapy, including trastuzumab (Herceptin), and recovered * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No anthracyclines for at least 22 weeks after completion of study therapy * No other concurrent chemotherapy * Concurrent hormone replacement therapy allowed * No other concurrent hormonal therapy * At least 4 weeks since prior radiotherapy and recovered * No prior radiotherapy to more than 25% of the bone marrow-containing skeleton * No concurrent radiotherapy * At least 4 weeks since prior investigational agents and recovered * At least 7 days since prior known substrates of cytochrome P450-3A4 (CYP3A4) * At least 7 days since prior parenteral antibiotics * No concurrent substrates of CYP3A4 * No concurrent parenteral antibiotics * No other concurrent experimental medications

Study Objectives The aim is to study the effect of a systematic approach to symptom identification and management with disease specific and clinically developed PRO (HM-PRO) with a 12 month follow up in outpatient care in patients with chronic hematological malignancy. Conditions: Hematologic Malignancy Intervention / Treatment: OTHER: HM-PRO Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * adults \> 18 years * diagnosed and undergoing follow up for a hematological malignancy in the outpatient clinic, Rigshospitalet * The patients can be included approximately six months after initial diagnosis if in stable condition. * able to manage an e-mail account Exclusion Criteria: * Patients who do not understand, read and speak Danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.

Study Objectives This clinical trial studies diffuse optical imaging with indocyanine green solution in imaging pelvic lymph nodes in patients with stage II prostate cancer undergoing surgery. Indocyanine green solution is a special dye that can help doctors see the lymph nodes and blood vessels during surgery when visualized under diffuse optical imaging. Indocyanine green solution may improve the ability to detect lymph nodes and may lead to improved accuracy of lymph node removal. Conditions: Stage IIA Prostate Cancer, Stage IIB Prostate Cancer Intervention / Treatment: DRUG: indocyanine green solution, OTHER: diffuse optical imaging, PROCEDURE: robot-assisted laparoscopic surgery, PROCEDURE: therapeutic lymphadenectomy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Stage 2, intermediate to high risk (per D'Amico criteria) localized prostate cancer with a prostate gland size =\< 100 grams * Intermediate risk: prostate specific antigen (PSA) between 10-20, Gleason grade 7, or clinical stage T2b * High risk: PSA \> 20 , Gleason grade \>= 8, or clinical stage \>= T2c * Life expectancy of at least 10 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * The subject must be able to comply with the study procedures * All subjects must have the ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as total bilirubin \> 1.5 x normal * Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as serum glutamic oxaloacetic transaminase (SGOT) \> 2 x normal * Prior prostate surgery (i.e. transurethral resection of the prostate), or any prior abdominal or pelvic surgery, most specifically for surgeries that may have included any form of lymphadenectomy or anatomic changes * History of androgen deprivation therapy, any prior chemotherapy, or any prior radiation therapy to the pelvis * Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes * Subject in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered * Subject has any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure * The presence of medical conditions contraindicating general anesthesia or standard surgical approaches

Study Objectives To determine clinical efficacy of glycolic acid 15%plus salicylic acid 2% gel in treatment of Plane wart . Conditions: Plane Wart Intervention / Treatment: OTHER: Glycolic Acid Plus Salicylic Acid in Treatment of Plane Wart Location: Egypt Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion criteria Site: face Exclusion criteria : 1. Photosensitivity 2. Scaring keloid 3. Herpes simplex 4. Pregnancy \& Lactation

Study Objectives The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive leuprolide acetate administered subcutaneously once monthly during 3 months. Conditions: Prostate Cancer Intervention / Treatment: DRUG: leuprolide acetate FluidCrystal® injection depot, DRUG: leuprolide acetate Location: Hungary, Finland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Men ≥40 and ≤85 years of age * Histological or cytological proven adenocarcinoma of the prostate requiring hormone therapy * Life expectancy over 12 months * World Health Organisation/ The Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1 or 2 * Adequate and stable renal function * Adequate and stable hepatic function Exclusion Criteria: * Evidence of brain metastasis, spinal cord compression, or urinary tract obstruction * Serum Testosterone levels below 150 ng/dL at Screening visit * Medical or radiological prostate cancer treatments within 2 months prior to the Screening visit * Surgical treatment of prostate cancer within 2 weeks prior to the Screening visit * Prior orchiectomy, hypophysectomy, or adrenalectomy * Prior use of LHRH agonists within 12 months prior to the Screening visit and during the study

Study Objectives RATIONALE: The timing of breast cancer surgery within the menstrual cycle may affect outcome. It is not yet known if treatment is more effective during the initial or final phase of the menstrual cycle. PURPOSE: Phase III trial to determine the effect of menstrual cycle phase at surgery in treating premenopausal women who have stage I, stage II, or stage III breast cancer. Conditions: Breast Cancer Intervention / Treatment: PROCEDURE: conventional surgery Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: * Histologically confirmed stage I, II, or III primary breast cancer undergoing breast surgery * Invasive disease (e.g., lobular or ductal) * No bilateral disease * No distant metastases * Premenopausal * Regular menses (no amenorrhea of more than 90 days) without hormone replacement * Documented last menstrual period * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * Premenopausal Sex: * Female Menopausal status: * See Disease Characteristics Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other prior malignancies * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No preoperative chemotherapy Endocrine therapy: * No concurrent hormonal replacement therapy * No concurrent interruptive oral contraceptive use of less than 3 months Radiotherapy: * Not specified Surgery: * See Disease Characteristics * No prior hysterectomy and/or bilateral oophorectomy

Study Objectives RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. This may be an effective treatment for liver cancer. PURPOSE: This phase I/II trial is studying the side effects and best dose of external-beam radiation therapy in treating patients with liver cancer that cannot be removed by surgery. Conditions: Liver Cancer Intervention / Treatment: RADIATION: 3-dimensional conformal radiation therapy, RADIATION: intensity-modulated radiation therapy, RADIATION: stereotactic body radiation therapy Location: Netherlands, Switzerland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: * Histologically, cytologically, or radiologically confirmed hepatocellular carcinoma * Clinical stage T2-4, N0-1, M0 (stage II, IIIA, IIIB, IIIC) OR unresectable T1, N0-1, M0 (stage I) disease * M1 disease allowed in phase I if at least 90% of the tumor load (volume) is in the liver * Measurable disease (at least one liver lesion that can be measured in at least one dimension as ≥ 10 mm in multislice CT scan/MRI) * Volumetry of liver tumor and residual liver tissue: residual liver volume (= total liver volume - gross tumor volume) has to be ≥ 800 mL and ≥ 40% of total liver volume * No operable disease (with curative intent or planned liver transplantation) * No presence of clinical ascites PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Cirrhosis Child-Pugh class A or B (Child-Pugh score of ≤ 9) * Hemoglobin ≥ 100 g/L * ANC ≥ 1,200/mm³ * Platelet count ≥ 50,000/mm³ * ALT and AST ≤ 7 times upper limit of normal (ULN) * AP ≤ 10 times ULN * Bilirubin ≤ 50 μmol/L * INR ≤ 2 * Creatinine clearance ≥ 50 mL/min * Functional left kidney (scintigraphy mandatory for phase I, phase II only if indicated) * Lipase ≤ 2 times ULN (phase I only) * Able to tolerate proton-pump inhibitors or H2 antagonists during radiation therapy * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 months after completion of study therapy * No prior malignancy allowed, except for the following: * Adequately treated cervical carcinoma in situ * Adequately treated localized nonmelanoma skin cancer * Any other malignancy from which patient has been disease-free for 5 years * No presence of medically uncontrolled encephalopathy * No myocardial infarction within the past 6 months * No esophageal varices ≥ grade 3, with red signs, or bleeding within the past 3 months * No symptoms of colitis, enteritis, esophagitis, fistula, gastritis, ileus, necrosis, perforation, stricture, or ulcer * No severe anorexia, constipation, dehydration, diarrhea, or vomiting * No serious underlying medical condition that, in the opinion in the investigator, would preclude study participation (e.g., active autoimmune disease or uncontrolled diabetes) * Portal vein thrombosis allowed * No psychiatric disorder precluding understanding of information on study related topics or giving informed consent * No nutritional intake \< 1500 calories per day (corrected) * No weight loss ≥ 15 % within the past 3 months PRIOR CONCURRENT THERAPY: * At least 8 weeks since prior transarterial chemoembolization (TACE), radiofrequency ablation, or radiotherapy (RT) unless progressive disease was documented after this therapy * At least 21 days since prior and no other concurrent treatment with experimental drugs * At least 21 days since prior and no other concurrent treatment on another clinical trial * At least 21 days since prior and no other concurrent anticancer therapy * No prior RT to the abdomen or caudal chest * Prior RT to pelvis allowed * Prior RT to chest must be above D5 vertebra * Portal vein embolization ligation or pre-RT TACE allowed * No concurrent treatment with steroids or non-steroidal anti-inflammatory drugs during RT (proton-pump inhibitor allowed)

Study Objectives The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and effective in the treatment of actinic keratoses (AK) on the face, following treatment with liquid nitrogen cryotherapy. Conditions: Actinic Keratosis Intervention / Treatment: DRUG: Aminolevulinic Acid, DRUG: Topical Solution Vehicle, DEVICE: BLU-U, PROCEDURE: Cryotherapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Four to fifteen AKs on the face * histologically confirmed presence of abnormal architecture and satellite atypical keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged skin adjacent to AKs * at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck area within the past five years Exclusion Criteria: * Pregnancy * history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis * lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area * skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy * Subject is immunosuppressed * unsuccessful outcome from previous ALA-PDT therapy * currently enrolled in an investigational drug or device study * has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment * known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol) * has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face * use of the following topical preparations on the extremity to be treated: * Keratolytics including urea (greater than 5%), alpha hydroxyacids \[e.g.glycolic acid, lactic acid, etc. greater than 5%\], salicylic acid (greater than 2%) within 2 days * Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks * Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-fluorouracil (5-FU), diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks * use of systemic retinoid therapy within 6 months