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Study Objectives The purpose of this prospective observational study is to understand the relationship between paclitaxel exposure and development of peripheral neuropathy during treatment. Conditions: Breast Cancer Intervention / Treatment: DRUG: Paclitaxel 80mg/m2 weekly x 12 weeks Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Diagnosis of invasive breast cancer * Systemic treatment with paclitaxel for curative intent (neoadjuvant, adjuvant, or oligometastatic disease per PI discretion) * 80 mg/m2 1-hour infusions weekly for up to 12 weeks * Female sex -\>18 years old * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Any prior or concurrent treatment with neurotoxic chemotherapy including any taxane, vinca alkaloid, platinum, bortezomib, or thalidomide. Note that concurrent biologic treatment with trastuzumab/pertuzumab for HER2+ patients or prior treatment with Adriamycin/cyclophosphamide are not reasons for exclusion. * Distant metastatic disease * Concurrent treatment with duloxetine or enrollment on clinical study of neuroprotective agent * History of allergic reaction to paclitaxel or cremophor EL * Current signs or symptoms of severe peripheral neuropathy * Known family history of hereditary peripheral neuropathy or Charcot-Marie-Tooth disease * Known current pregnancy

Study Objectives Many men develop urine leakage after prostate cancer surgery. Usually it is temporary, but pelvic floor muscle training and exercise (including urine control strategies) have been shown to reduce the time to regaining urine control. This study tests an evidence-based, pelvic floor muscle training program that has been adapted to telehealth format and pilot tested in a VA-funded pilot/developmental trial. Training is begun 1-4 weeks before surgery and continued 6 months after surgery. Content is accessed on a secure website in daily 10-minute sessions which transition to weekly sessions for post-operative months 3-6. In the investigators' pilot study, Veterans reported that they appreciated receiving the training in the privacy of their homes, enjoyed the interactive style of the learning experience, and felt better prepared to deal with urine leakage and empowered with new knowledge and skills to help themselves. Content for both control and treatment groups includes general information about prostate cancer; perioperative care; wetness, odor and skin care management. The treatment group will ALSO receive pelvic floor muscle training and bladder control strategies. Outcomes are measured with brief validated questions administered by the telehealth platform, and again at 9 and 12 months by mailed questionnaire or the telehealth platform. Conditions: Urinary Incontinence, Prostate Cancer Intervention / Treatment: BEHAVIORAL: Pelvic Floor Muscle Training, BEHAVIORAL: Perioperative Care and Wetness Management Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Scheduled to undergo a radical prostatectomy for treatment of prostate cancer and enrolled at the Birmingham, Philadelphia, or Atlanta VA Medical Centers or the affiliated University Medical Centers * Ability to read English. * Internet access Exclusion Criteria: * Urinary Incontinence in the 6 months prior to prostate cancer surgery (other than post-void dribbling) * Less than 1 week before surgery

Study Objectives There is research supporting treatment of superficial fibromatoses (palmar fibromatosis and keloids) with triamcinolone acetonide injections. These lesions are histologically similar to deep fibromatoses (desmoid tumors). Currently there is little literature evaluating the response of desmoid tumors to injections of triamcinolone acetonide. The investigators aim to perform a pilot study evaluating the response of desmoid tumors to intralesional triamcinolone. If positive results are observed (based on RECIST criteria), then a phase II study will be initiated. Conditions: Fibromatosis Intervention / Treatment: DRUG: Triamcinolone Acetonide 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 1. Patients with histologically confirmed diagnosis of extra-abdominal aggressive fibromatosis (desmoid tumor). 2. At least one of the following: Desmoid tumor that has shown stability in size over consecutive axial imaging (CT or MRI) at least 3 months apart AND presence of any tumor-related symptoms OR an increase in size based on consecutive axial imaging (CT or MRI). Additionally, for patients with a desmoid tumor which has been irradiated, at least a 10% increase in size by volume since receiving radiotherapy is required. 3. ECOG Performance status of \< 1. 4. Able to participate in three guided injection procedures. 5. Able to undergo a MRI with and without contrast of the tumor site. 6. Age \> 18 years and ≤ 89 years. 7. Willing to sign an informed consent form. 8. Willing to comply with protocol procedures including required 21 month follow up after last injection. Exclusion Criteria 1. Allergy to the test drug or a component of its formulation 2. Patients with a desmoid tumor which has been stable in size and without symptoms or decreased in size over the prior three months utilizing axial imaging according to the following criteria; (a) 10% when comparing a prior CT scan to a current MRI, or (b) more than 5% when comparing a prior MRI to a current MRI. 3. The patient must not be on anticoagulation (Aspirin okay) 4. The patient should not be pregnant or trying to become pregnant, and willing to use adequate contraception during study participation to avoid pregnancy 5. The patient should not be breastfeeding 6. Active infection that in the opinion of the investigator compromises the patient's participation (i.e., a UTI is ok) 7. A diagnosis of idiopathic thrombocytopenia purpura 8. Undergoing concomitant treatment (including radiation, systemic treatment, surgery, or other tumor directed therapy). The patient must be off of the systemic therapy for a period of at least 5 drug half-lives prior to enrolling in the study. 9. Uncontrolled or poorly controlled diabetes mellitus 10. Has an uncontrolled illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that in the opinion of the investigator would limit compliance with study requirements

Study Objectives The overall goal of this research is to develop a platform that can increase patient access to expert skin cancer diagnostic services via telemedicine. This is especially important for medically underserved areas where melanoma outcomes are worse than in areas with greater access to in-person evaluations. If successful, the widespread availability of such services would be combined with public education efforts to encourage individuals with changing skin lesions to seek evaluation. With decreased travel times to high quality diagnostic services, such efforts may decrease the diagnosis of more advanced melanomas (with a concomitant increase in the diagnosis of earlier stage tumors), and potentially decrease melanoma mortality. Conditions: Skin Cancer Intervention / Treatment: DEVICE: Nevisense 3.0, DEVICE: Dermlite Cam, PROCEDURE: Skin biopsy, DEVICE: Barco Demetra 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: * Be 18 years of age or older * Have 1-3 lesions for evaluation Exclusion Criteria: * Lesions of the hair-bearing scalp, in the mouth, on the lips, genitalia, nails, on/around the eyes, inside the ear

Study Objectives To determine the maximum tolerated dose (MTD) of CRA-024781 IV given by 2-hour intravenous infusions in patients with refractory solid or hematologic malignancies. To evaluate safety and tolerability, pharmacokinetics and pharmacodynamics, and to evaluate bioavailability of CRA-024781 IV when administered in a single oral dose. Conditions: Hematologic Neoplasms, Neoplasms Intervention / Treatment: DRUG: CRA-24781 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * age ≥ 18 years * histologically confirmed solid or hematologic malignancy that is refractory to standard therapy or for which no standard therapy exists * estimated life expectancy \> 12 weeks * ECOG performance grade ≤ 2 * creatinine ≤ 1.5 X institutional upper limit of normal or creatinine clearance \> 50 mL/min * total bilirubin within institutional limits (unless elevated from documented Gilbert's syndrome) * AST and ALT ≤ 2.5 X institutional upper limit of normal (≤ 5 x institutional upper limit of normal in the presence of liver metastases) * platelet count ≥ 100,000/µL * absolute neutrophil count (ANC) ≥ 1500/µL * Hgb ≥ 9.0 g/dL * patients with previously treated brain metastases who are not on corticosteroids are eligible * effective contraceptive method (e.g., intrauterine device, oral contraceptive, or barrier device) must be used during the study by male and female patients of childbearing potential * ability to understand and willingness to sign a written informed consent Exclusion Criteria: * patients who have had immunotherapy, chemotherapy, or radiotherapy within 4 weeks (within 6 weeks for nitrosoureas or mitomycin C) prior to study entry; study entry defined as first day of drug dosing * patients who have undergone major surgery within 4 weeks prior to study entry * patients who are receiving another investigational drug * patients with active CNS metastases or leptomeningeal disease not controlled by prior surgery or radiotherapy * uncontrolled illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements * risk factors for QTc prolongation and/or Torsade de Pointes * patients with known HIV infection * concurrent systemic hormonal therapy except: stable LHRH agonist therapy for prostate cancer; hormonal therapy (e.g., megestrol) for appetite stimulation; nasal, ophthalmic, and topical glucocorticoid preparations when appropriate; stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency; or oral contraceptives * patients who have other medical or psychiatric illness or organ dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with the evaluation of the safety of the study agent * pregnant or lactating women (female patients must have a negative serum pregnancy test within 7 days of study entry) * patients who have previously received histone deacetylase inhibitors

Study Objectives The purpose of this study is to evaluate an investigational drug called tabalumab in participants with Multiple Myeloma (MM) who have tried at least one other therapy in the past. Tabalumab will be given in combination with standard doses of two other drugs that are often used to treat MM. Study doctors will collect information about the effectiveness and side effects of this therapy. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Placebo, DRUG: Dexamethasone, DRUG: Bortezomib, BIOLOGICAL: Tabalumab Location: Taiwan, Korea, Republic of, Netherlands, Poland, Turkey, Germany, United States, Greece, Canada, Spain, Brazil, France, United Kingdom, Italy, Mexico Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Have symptomatic and/or progressive MM that was previously treated with at least 1 and no more than 3 prior lines of therapy * Have measurable disease * Have given written informed consent prior to any study-specific procedures * Have adequate organ function * Treatment with prior autologous transplant is permitted Exclusion Criteria: * Are enrolled in or discontinued from a clinical trial of any drug or device within 21 days prior to the first dose of assigned study treatment * Have had less than a minimal response or have had progressive disease within 60 days of most recent therapy with a proteasome inhibitor * Plan to proceed to autologous transplant for consolidation after participation in this trial * Have an active infection or ongoing treatment for systemic infection ("ongoing treatment" does not include prophylactic anti-infectives),, chest x-ray suggestive of tuberculosis, or history/risk of chronic/latent infection that may reactivate in the presence of study therapy * Have any of the following: * positive test results for human immunodeficiency virus (HIV) * positive test for hepatitis B, defined as positive for hepatitis B surface antigen (HBsAg+), OR positive for anti-hepatitis B core antibody AND positive for hepatitis B deoxyribonucleic acid (HBV DNA), OR positive for anti-hepatitis B surface antibody (HBsAb+) AND positive for hepatitis B deoxyribonucleic acid (HBV DNA) * positive test results for hepatitis C virus (HCV), defined as positive for hepatitis C antibody (HepCAb) AND confirmed positive via the hepatitis C recombinant immunoblot assay * Have had significant allergy to human/humanized monoclonal antibodies that, in the opinion of the investigator, poses an unacceptable risk to the participants * Have known hypersensitivity or contraindication to any of the study therapies or excipients * Prior allogeneic hematopoietic stem cell transplant * Prior therapy with experimental agents targeting B-cell activating factor (BAFF), including LY2127399 * Have corrected QT (QTc) interval \>500 millisecond (msec) on baseline 12-lead electrocardiogram (ECG) * Have Waldenstrom's macroglobulinemia * History of malignancy with adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, in situ prostate cancer, are eligible regardless of the time of diagnosis/treatment

Study Objectives Most systemic therapies are chosen on the basis of large randomized clinical trials; however, tumour heterogeneity means that cancers with similar histological features may have substantially different underlying biological drivers. The investigators propose that applying personal genomic information prospectively obtained in a clinically realistic timeframe to assist in chemotherapy decision-making could result in more effective and efficient cancer treatment. This study will investigate this approach in a cross section of advanced cancers to examine timeliness, deliverability, rate of actionable targets identified, and our ability to expand this approach into a larger clinical trial setting. Conditions: Advanced Incurable Cancers Intervention / Treatment: GENETIC: in depth genomic sequencing Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: 1. Subjects must have histologically or cytologically confirmed diagnosis of cancer 2. This cancer must be incurable, as defined by their treating oncologist (generally because of advanced stage). 3. Subjects must agree to provide archival tissue and agree to undergo a study specific biopsy and blood test for genetic analysis. All subjects would have a biopsy and blood samples at progression if it could be done safely. 4. ECOG PS 0 or 1. 5. Age \> 18 years of age. 6. Subject consent must be obtained according to the BCCA requirements. 7. Subject must be accessible for treatment and follow-up. Subjects must be registered at the BCCA Vancouver site. Exclusion Criteria: 1. Unable or unwilling to undergo tumour biopsy(s) and/or blood/skin samples for normal DNA. 2. Significant medical condition that in the opinion of the treating oncologist renders the subject not suitable for participation.

Study Objectives There is a degree of uncertainty regarding the role of perioperative chemotherapy (CTx) in the treatment of resectable colorectal liver metastases (CRLM). In the clinical practice, the combination of surgery and CTx is increasingly accepted as treatment for CRLM, especially in the context of patients with synchronous disease or metachronous disease with a high risk of recurrence. However, controversy exists whether all patients with resectable CRLM benefit from perioperative CTx. There is paucity of good quality studies on this topic. A pooled analysis of two phase III randomized clinical trial, closed prematurely because of slow accrual, showed a marginal statistical significance in favor of adjuvant CTx. Nevertheless, long term results of the EPOC trial founded benefit in disease free survival (DFS) with no difference in overall survival (OS) when perioperative CTx with FOLFOX4 was compared with surgery alone for resectable CRLM. Furthermore, a retrospective series from Ayez et al showed that patients with a high CRS benefit from neo-adjuvant CTx while in patients with a low risk profile did not. On the other side, another retrospective series from the MSKCC showed the timing of additional CTx for resectable CRLM was not associated with improved outcomes. The ongoing CHARISMA trial is currently comparing the outcomes of neo-adjuvant CTx followed by surgery versus surgery alone in high-risk patients with resectable CRLM. This uncertainty regarding CRLM management may partly be due to the fact that these studies are not well powered to detect minor differences in long term outcomes and they often involved a very heterogenous group of patients with both synchronous and metachronous CRLM, not stratified by clinical risk score (CRS) as described by Fong et al. Conditions: Metastatic Colorectal Cancer, Metastatic Liver Cancer Intervention / Treatment: OTHER: Liver resection and Neoadjuvant chemotherapy, OTHER: Liver resection and Adjuvant chemotherapy, OTHER: Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy, PROCEDURE: Liver resection Location: Spain, France, United Kingdom Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Patients older than 18 years with resectable liver metastases of histologically confirmed primary colorectal carcinoma. * Minimum follow-up of five years. Exclusion Criteria: * Patients with extrahepatic disease

Study Objectives The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6. Conditions: Crohn Disease Intervention / Treatment: BIOLOGICAL: certolizumab pegol (CDP870, CZP), OTHER: Placebo Location: Estonia, New Zealand, Austria, Israel, Australia, Romania, Latvia, Czechia, Chile, Hungary, Germany, United States, Canada, Russian Federation, Poland, Italy, Finland, Ukraine, Belgium, Brazil Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * male/female * 18 - 75 years inclusive * diagnosis of Crohn's disease confirmed * moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450) * no previous treatment with anti-tumor necrosis factor (anti-TNF) medications Exclusion Criteria: * previous participation in a certolizumab pegol study * general exclusion criteria as common for studies in this indication

Study Objectives This study investigates the feasibility and safety of delivering radiation therapy only to part of the breast, (the tumor bed and selected areas) rather than the whole breast, for patients with early stage breast cancer. Conditions: Breast Neoplasms Intervention / Treatment: RADIATION: Partial Breast Irradiation (PBI) 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. Histologic Documentation: * Patients will have histologically confirmed Unicentric Stage I (T1 N0 M0) invasive ductal breast cancer. * Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen. * Tubular, mucinous and medullary variant histologies of infiltrating ductal carcinoma are permitted. * Low-grade DCIS (I and II) of 2 cm or less with histologically negative margins of at least 2 mm margins (or a negative re-excision) are permitted. * Women age 70 years or older with T1 invasive ductal carcinoma which are estrogen-receptor positive (ER+) with clinically negative axillary nodes who do not undergo surgical lymph node evaluation are also eligible if patient will take hormonal therapy. * Patients with T1N0 (i+) tumors on sentinel lymph node mapping or dissection (i.e. is tumor deposit is 0.2mm or less, regardless of whether the deposit is detected by IHC or H\&E staining) will also be eligible, provided that completion axillary dissection has been performed to confirm N0 status. * In the case where invasive cancer is present, the invasive cancer's pathology will be used regardless if DCIS is also present. 2. Prior Treatment: Patient may have been treated with adjuvant chemotherapy. Patients may be on adjuvant hormonal therapy or begin hormonal therapy following XRT at the discretion of the medical oncologist. Radiation therapy should begin within: * 4-12 weeks from definitive surgical procedure * 2-6 weeks after chemotherapy, if chemotherapy given first * Radiation cannot be delivered concurrently with chemotherapy. 3. Age \>= 18 years of age 4. ECOG Performance Status 0-2. 5. Signed Informed Consent Exclusion Criteria The following guidelines are to assist physicians in selecting patients for whom protocol therapy is safe and appropriate. Physicians should recognize that the following may seriously increase the risk to the patient entering this protocol. Patients who meet the following criteria should not be entered in this study: 1a Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5 cm of uninvolved tissue; alternatively, discontiguous tumors that are clinically or mammographically within separate breast quadrants or subareolar central region. 1. b Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region. 2. Tumor \> 2.0 cm, nodal involvement on H\&E staining, or metastatic involvement 3. Histological evidence of: 1. Lymphovascular invasion: as defined by a tumor embolus present in an endothelial-lined space; cases with tumor emboli present in a space not lined by endothelial cells but otherwise very suspicious for an angiolymphatic space were also considered ineligible. 2. EIC (Extensive Intraductal Component): defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumor area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor, or as a predominantly intraductal tumor with one or more areas of focal invasion 7, 55. 3. Invasive Lobular Carcinoma 4. Infiltrating carcinoma with mixed ductal and lobular features: cases with ambiguous or mixed histologic features that showed positive E-cadherin staining throughout the tumor by immunohistochemistry were classified as ductal type and considered eligible 56, 57. 5. Infiltrating papillary carcinoma 6. Margins: In-situ or invasive carcinoma present less than 2 mm from the inked resection margin. 4. History of cosmetic or reconstructive breast surgery 5. Psychiatric illness which would prevent the patient from giving informed consent. Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or connective tissue diseases (lupus, systemic sclerosis or other collagen vascular diseases) which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. 6. Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 5% risk of relapse within three years. 7. Patients with diffuse (\> 1 quadrant or \> 5cm) suspicious microcalcifications 8. Women who are pregnant.

Study Objectives Multidrug resistance (MDR) is a cause of treatment failure in many cancer patients. MDR refers to a phenotype whereby a tumor is resistant to a large number of natural chemotherapeutic drugs. Having prior knowledge of the presence of such resistance would decrease morbidity from unsuccessful therapy and allow for the selection of individuals who may benefit from co-administration of MDR inhibiting drugs. The Tc-99m labeled single photon emitting radiotracers sestamibi and tetrofosmin have shown some predictive value. However, positron-emitting (PET) radiotracers, which allow for dynamic, quantitative imaging, hold the promise of more accurate and specific identification of MDR tumors. Objective: To obtain human safety data, to demonstrate imaging feasibility with FPAC, to obtain human biodistribution and to obtain preliminary evidence of breast tumor uptake concordance with response to therapy. Conditions: Breast Cancer Intervention / Treatment: DRUG: 4- [F-18] fluoropaclitaxel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Normal Volunteers Inclusion Criteria: * Subjects must be 18 years or older for inclusion in this study. Because no dosing or adverse event data are currently available on the use of FPAC in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable. * All subjects must sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines. * If female, the subject must be postmenopausal for a minimum of one year, or surgically sterile, or be within 14 days of onset of a menstrual period or have a negative beta human chorionic gonadotropin (ßHCG) blood test. * Subjects must have normal organ and marrow function as defined below: * Leukocytes \>3,000/μL * absolute neutrophil count \>1,500/μL * platelets \>100,000/μL * total bilirubin within normal institutional limits * aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \<= 2.5 times the institutional upper limit of normal * Creatinine within normal institutional limits OR, in subjects with creatinine levels above institutional normal, creatinine clearance \>60 mL/min/1.73 m2 Exclusion Criteria: * Subject with a known bleeding disorder * Subjects who have received chemotherapy within 1 year of entry into study * Subjects with a history of liver or kidney disease * Subjects who are receiving any other investigational agents * Subjects having severe claustrophobia or other condition that would make them unable to lie still for the duration of the study * Subjects with immunodeficiencies that predispose a subject to specific or non-specific mediator release * Subjects with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Subjects who are pregnant or lactating or who suspect they might be pregnant. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with FPAC, breastfeeding should be discontinued if the mother receives FPAC. Breast Cancer Patients Inclusion Criteria: * Subjects must have a history of histologically or cytologically confirmed breast cancer with estimated lesion size of \>1cm. * Subjects must be 18 years or older for inclusion in this study. Because no dosing or adverse event data are currently available on the use of FPAC in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable. * All subjects must sign a written informed consent document and a HIPAA authorization in accordance with institutional guidelines. * If female, the subject must be postmenopausal for a minimum of one year, be surgically sterile, be within 14 days of onset of a menstrual period, or have a negative ßHCG blood test. * Subjects must have normal organ and marrow function as defined below: * Leukocytes \>3,000/μL * absolute neutrophil count \>1,500/μL * platelets \>100,000/μL * total bilirubin within normal institutional limits * aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \<= 2.5 times the institutional upper limit of normal * Creatinine within normal institutional limits OR, in subjects with creatinine levels above institutional normal, creatinine clearance \>60 mL/min/1.73 m2 Exclusion Criteria: •as above

Study Objectives This phase II trial studies how well combination chemotherapy with or without rituximab works in treating participants with stage III-IV classic Hodgkin lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab with combination chemotherapy may work better in treating participants with classic Hodgkin lymphoma. Conditions: Classic Hodgkin Lymphoma, Lugano Classification Stage III Hodgkin Lymphoma AJCC v8, Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8 Intervention / Treatment: DRUG: Bleomycin, DRUG: Dacarbazine, DRUG: Doxorubicin Hydrochloride, BIOLOGICAL: Rituximab, DRUG: Vinblastine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Previously untreated patient with classical Hodgkin's lymphoma patients with stage III and IV * International Prognostic Score of \> 2 (patient must have \> 2 of the following risk features: Male, \>= 45 years of age, stage IV, albumin \< 4, white blood cell count \[WBC\] \>= 15, lymphocytes \< 8% or \< 600, hemoglobin \[Hgb\] \< 10.5) * Must sign a consent form * Absolute neutrophil count (ANC) \>= 1,500/microL * Platelet \> 100,000/microL * Left ventricular ejection fraction (LVEF) \>= 50% by multigated acquisition (MUGA) scan or echocardiogram * Serum creatinine \< 2 mg/dl * Serum bilirubin \< 2 mg/dl * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2 x upper limit of normal (ULN) * Bi-dimensionally measurable disease Exclusion Criteria: * Lymphocyte predominant Hodgkin's lymphoma * Known human immunodeficiency virus (HIV) infection * Pregnant women and women of child bearing age who are not practicing adequate contraception * Prior chemotherapy or radiation therapy * Severe pulmonary disease as judged by the principal investigator (PI) including chronic obstructive pulmonary disease (COPD) and asthma * Active infection requiring treatment with intravenous therapy * Presence of central nervous system (CNS) lymphoma * Concomitant malignancies or previous malignancies within the last 5 years (exception made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix) * Active hepatitis B or C infection

Study Objectives The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma multiforme. Conditions: Glioblastoma Intervention / Treatment: DRUG: Temozolomide, RADIATION: Radiotherapy Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: Only the patients who meet all these criteria can be enrolled in the study: * Patients with prior histological confirmation of newly diagnosed primary glioblastoma multiforme in supratentorial cerebral hemisphere. * Gross total resection or partial resection (imaging) \>70%. * At least be capable to obtain a tissue sample for MGMT analysis during surgery. * Chemo-radiotherapy to be expected from Week 5 (Day 29) after surgery. * Age \>=18 and \<=70 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Life expectancy \>=9 months. * Laboratory test values must satisfy the following criteria: * absolute neutrophil count \>=1.5 x 10\^9/L; * platelet count \>=100 x 10\^9/L; * hemoglobin \>=80 g/L; * blood urea nitrogen and creatinine \< 1.5 x upper limit of normal value (ULN); * total bilirubin and direct bilirubin \< 1.5 x ULN; * alanine aminotransferase and aspartate aminotransferase \< 3 x ULN; * alkaline phosphatase \< 2 x ULN. * Patients must be willing to provide written informed consent. * Patients of child-bearing potential (including female subjects and the female partners of male subjects) must use an effective method of contraception. Exclusion Criteria: Patients will not be enrolled if any of the following criteria apply: * Patient with previous or current malignancies (except melanoma) at other sites, unless disease free for at least 3 years. * Patient who received chemotherapy, radiotherapy for study indication, or other medications for antitumor indication prior to surgery. * Patient with recurrent or multiple malignant glioma (including gliomatosis cerebri). * Patient with metastatic lesions at the subtentorial or outside of calvaria. * Patient who received chemotherapy or radiotherapy sensitizers for head or neck tumor. * Patient who received radiotherapy at head or neck which leads to radiotherapy domain overlapping. * Patient with acute infections requiring intravenous antibiotics. * Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction). * Known human immunodeficiency virus (HIV)-positive or acquired immune deficiency syndrome (AIDS)-related illness. * Woman who is pregnant or breastfeeding. * Patient with a history of hypersensitivity to temozolomide or other analogic alkylating agents. * Patient with any other conditions under which investigators think the subject is not suitable for enrolment, such like having known that the subject may not have good compliance.

Study Objectives The presence of IDH mutation is associated with worse survival in patients with myelofibrosis. Moreover IDH mutations are among the most frequently encountered events in MPNs that have progressed to acute myeloid leukemia. Ruxolitinib, a JAK1/2 inhibitor, and enasidenib an IDH2 inhibitor are effective and tolerable treatments for patients with myelofibrosis (MF) and acute myeloid leukemia (AML), respectively. The study team hypothesize that the combination of these agents in patients with MPN with an IDH2 mutation will improve the overall clinical response to therapy. Conditions: Accelerated/Blast-phase Myeloproliferative Neoplasm, Chronic-phase Myelofibrosis, IDH2 Mutation Intervention / Treatment: DRUG: Ruxolitinib, DRUG: Enasidenib Location: Canada, 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 be ≥ 18 years at the time of signing the Informed Consent Form (ICF). * Understanding and voluntary signing an IRB-approved informed consent form. * Diagnosis of: 1. Accelerated-phase (≥ 10% blasts in PB or BM) or blast-phase (≥ 20% blasts in PB or BM) myeloproliferative neoplasm (with history of prior myelofibrosis, polycythemia vera, or essential thrombocythemia) 2. Previously treated patients with myelofibrosis with persistent disease or progressive disease (persistent or progressive splenomegaly, leukocytosis, anemia, or thrombocytopenia) with intermediate-1 or greater risk disease according to 2013 International Working Group (IWG) criteria, and 4-9% circulating blasts. * Demonstration of an IDH2 mutation. * Platelet count \> 75,000 X 109/L for chronic phase myelofibrosis patients. * Prior therapy with either ruxolitinib or enasidenib is permitted, but not a combination of ruxolitinib and enasidenib. * Patients with chronic phase myelofibrosis on ruxolitinib must be on the drug for at least 3 months and on a stable dose for at least one month. * Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. ECOG 3 status will be allowed if attributable to MPN. * Patients must have adequate organ function as demonstrated by the following: a. Direct bilirubin \< 2.0mg/dL, unless due to Gilbert's disease or current elevations in direct bilirubin associated with existing enasidenib use. b. Serum creatinine\< 2.0 mg/dL. c. ALT and AST ≤ 3x upper limit of normal (unless transaminitis is considered to be related to MF). * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to starting enasidenib and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking enasidenib. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. * All study participants must be able to swallow oral medication. * Ability to adhere to the study visit schedule and all protocol requirements. EXCLUSION CRITERIA: * Use of any other standard anti-neoplastic drug or growth factor (e.g., anagrelide, G-CSF, lenalidomide, thalidomide clofarabine) except hydroxyurea or experimental drugs, with the exception of ruxolitinib or enasidenib, less than 14 days or 5-half-lives, whichever is longer, prior to starting study therapy and/or lack of recovery from all toxicity (except for alopecia) from previous therapy to Grade 1 or better. a. Patients will be permitted to receive hydroxyurea while on study for up to a total of 3 cycles of combined therapy. * Known prior clinically relevant hypersensitivity reaction to ruxolitinib or enasidenib. * Prior therapy with enasidenib in combination with ruxolitinib. * Concurrent use of strong inducers of CYP3A4 (Rifampin, St. John's Wort, Carbamazepine, Phenytoin) and/or the following strong inhibitors of CYP3A4 (protease inhibitor containing HIV anti-retrovirals, cobicistat, clarithromycin, itraconazole, ketoconazole, nefazodone, and telithromycin) are prohibited. Also prohibited are CYP2C9 substrate medications that have a narrow therapeutic range: phenytoin and warfarin. * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form, which places the subject at unacceptable risk if he/she were to participate in the study or which confounds the ability to interpret data from the study. * Lactating females. * Active uncontrolled infections. * Patients with active malignancy of other type than required for this study are not eligible with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received. * Subject has significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association (NYHA) Class III or IV congestive heart failure; acute coronary syndrome (ACS); and/or stroke; or left ventricular ejection fraction (LVEF) \< 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 28 days prior to the start of study treatment. * QTc interval (Fridericia's correction \[QTcF\]) \> 450 ms All inclusion and exclusion criteria will be reviewed by the Investigator or qualified designee to ensure that the patient qualifies for the trial.

Study Objectives Worldwide, \>1.3 million adults are diagnosed with a gynecologic cancer each year. With rising survival rates, there are an increasing number of adults experiencing negative body image and decreased sexual functioning, resulting in reduced emotional, psychological, and social wellbeing and quality of life (QoL). It is vital that adults have access to programs focused on improving their body image and sexual functioning after a gynecologic cancer diagnosis. The Ottawa Regional Cancer Foundation (ORCF) is a non-for-profit, community-based organization offering support to persons with cancer. Strong university-community partnerships are essential to enhance translational and implementation research efforts. Stakeholders from academia, the healthcare sector, and the community (ORCF) are partnering to establish and implement an evidenced-based yoga program co-created with adults diagnosed with gynecologic cancer and yoga instructors to address the wellbeing needs of adults diagnosed with gynecologic cancer. The specific objectives of this mixed-methods feasibility trial are to: (1) evaluate the feasibility (recruitment, retention, adherence, intervention fidelity) of (a) the yoga program and (b) the trial methods the investigators propose to use to evaluate its benefits in a future trial (i.e., trial methods), (2) evaluate the acceptability of the yoga program and evaluative methods, and (3) explore preliminary effects of the program on key self-reported outcomes. Data will be used to frame evaluation and implementation efforts. Conditions: Survivorship, Cancer Intervention / Treatment: BEHAVIORAL: Yoga Program Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Be at least 18 years of age * Have received a diagnosis of non-metastatic gynecologic cancer, * Are able to read/speak/understand English, * Have access to the Internet and an audio-visual device (e.g., computer, smart phone), * Able and willing to travel to the Ottawa Regional Cancer Foundation twice a week for the first 2 weeks of the program. Exclusion Criteria: * Be non-ambulatory (i.e., unable to walk or require the assistance of a mobility device), * Currently practicing yoga at least 1/week or have practiced consistently in the last 6 months (i.e., 1/week for 8 weeks).

Study Objectives This is a Phase I, first-in-human, open-label, dose-escalation study of MEGF0444A administered by IV infusion to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. Conditions: Solid Cancers Intervention / Treatment: DRUG: MEGF0444A Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on, or failed to respond to regimens or therapies known to provide clinical benefit Exclusion Criteria: * Inadequate hematologic and organ function * Anti-cancer therapy within 4 weeks prior to initiation of study treatment * Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia * Active infection or autoimmune disease * Pregnancy (positive pregnancy test) or lactation

Study Objectives The goal of this study is to investigate the safety and feasibility of treating patients with advanced hepatocellular carcinoma with a noninvasive device administering low level of amplitude-modulated electromagnetic fields. Conditions: Advanced Hepatocellular Carcinoma Intervention / Treatment: DEVICE: TheraBionic device Location: Brazil Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Advanced biopsy-proven HCC * Performance status ECOG 0-1 * Patients with Child Pugh A and B cirrhosis scores * Absence of medical or psychiatric contraindication which, in the opinion of the treating investigator, would make the patient's participation in this trial inappropriate. * Presence of one or more measurable lesion(s) according to the RECIST criteria. * Lesions treated with chemoembolization or ablation by means of radio frequencies will not be considered measurable in this study. * Patients on a liver transplant waiting list may be included * Patient must not have curative treatment options other than liver transplant * Patient may have been treated with intrahepatic treatment (chemoembolization or intrahepatic chemotherapy) or conventional chemotherapy or sorafenib or other experimental therapies prior to study entry. There is no limit for the number of prior therapies * Extra hepatic metastases do not constitute an exclusion criterion, except for active CNS metastases. * At least 4 weeks must have elapsed since administration of any anti-cancer treatment. * Other anti-cancer treatments are not permitted during this study * Patients must be more than 18 old and must be able to understand and sign an informed consent. * Patient must agree to be followed up according to the study protocol. * Patients may have either stable disease or disease progression according to the principal investigator assessment. * Patients who carry a pacemaker or any other implantable electronic device are not allowed in the study Exclusion Criteria: * Suspected or biopsy confirmed brain metastases * Patients with hepatic cirrhosis with Child-Pugh class C * Patients who have received a liver transplant. * Patients who had a surgical resection of the disease and who do not have measurable disease. * Pregnant women * Patients who still show objective response (complete or partial response) according to the RECIST criteria due to the last anti-cancer therapy * Patients diagnosed with another type of cancer (excluding basal cell carcinoma) during the last five last years or whose cancer diagnosed previously is not in remission

Study Objectives RATIONALE: Studying samples of tumor 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. It may also help doctors understand how patients respond to treatment. PURPOSE: This clinical trial is studying biomarkers in patients with rectal cancer undergoing chemotherapy and radiation therapy. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: capecitabine, DRUG: 5-fluorouracil, PROCEDURE: Surgical Resection, RADIATION: Radiation therapy Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: * Must have rectal or sigmoid-rectal junction adenocarcinoma confirmed by sigmoidoscopy and pathologic diagnosis of biopsy sample * Inferior margin of the tumor less than 15 cm from anal verge by rigid sigmoidoscopy or below the level of S1-2 at surgery * Candidate for chemotherapy and radiotherapy, as defined by any of the following: * Tumor staged as T3 or N1-2 by rectal sonography * Tumor occupying \> 40% of circumference of rectum * Tumor fixed to extra colonic structures as determined by digital rectal examination * Tumor \< 5 cm from sphincter mechanism * Patient has inoperable disease and is being treated for palliation * Pelvic or anastomotic recurrences of previously resected rectal cancer * Planning to undergo chemotherapy and radiotherapy * No sigmoid carcinoma (carcinoma proximal to the pelvic peritoneal reflection) PATIENT CHARACTERISTICS: * Not pregnant PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Study Objectives The working hypothesis is that oral administration of an attenuated strain of Salmonella typhimurium is safe and efficacious for patients with unresectable hepatic metastasis from a solid tumor cancer. The primary objective of the study is to determine the MTD of Salmonella typhimurium in the treatment. Conditions: Cancer of the Liver, Liver Cancer, Hepatoma, Liver Neoplasms, Biliary Cancer Intervention / Treatment: BIOLOGICAL: Salmonella typhimurium 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: * Histologic documentation of malignancy (any solid tumor type) that has spread to the liver and deemed unresectable, and for which no effective standard therapies are available. Patients with additional disease outside of the liver will be allowed. * Patients may have received any number of other prior therapies; however at least 3 weeks must have passed since last dose of chemotherapy or radiotherapy (6 weeks for Nitrosoureas or Mitomycin C) prior to study entry. * Must have recovered from all acute toxicities (defined per National Cancer Institute's Common Toxicity Criteria for Adverse Events 3.0 ≤ grade 1) associated with previous treatment. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Life expectancy of greater than 2 months as determined by the enrolling investigator * Adequate organ function within 1 week of treatment start defined as: * Adequate bone marrow reserve: leukocytes ≥ 3,000/μl, absolute neutrophil count (ANC) ≥ 1,500/μl, platelets ≥ 100,000/μl * Hepatic: bilirubin ≤1.5 times institutional upper limit of normal (×ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN * Renal: serum creatinine ≤ 1.5 x ULN * Women of child-bearing potential and sexually active men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion Criteria: * Unable to take oral drugs or clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to: malabsorption syndrome, major resection of stomach or small bowel * Receiving any other investigational agents * Known central nervous system metastases * Residing in a household or having close contact with pregnant women, young children (under the age of 1 year) or immune compromised persons * Engaged in activities that might pose a risk for widespread dissemination of this organism, including, but not limited to; health care, child care, or food service. * 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. * Pregnant or breastfeeding. Women of child bearing potential must have a negative serum or urine pregnancy test within 7 days of prior to the start of treatment. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Breast-feeding mothers will be asked to discontinue feeding infants prior to enrolling in the study. * Known HIV infection, need for chronic steroids or other immunosuppressant drugs, or other medical conditions that in the investigator's opinion result in a significant degree of immunosuppression. Patients without identified HIV risk factors are not required to have HIV testing to be eligible. * Known active hepatitis B or C infection * Known HLA B27 * Have permanent artificial implants (such as, but not limited to prosthetic valves and joints.) * Any other condition which in the investigator's opinion renders the patient at high risk for overwhelming infection

Study Objectives Phase 0 - Open label, Single dose study of siG12D LODER in Patients with operable adenocarcinoma of the pancreas. The primary endpoint: To assess efficacy and local distribution of siRNA out of eight high dose siG12D LODERs in patients diagnosed with operable adenocarcinoma of the pancreas. The Secondary endpoint: Short term tolerability and safety assessment Phase I - This study is designed to investigate the safety of siG12D LODER (Local Drug EluteR) in patients diagnosed with adenocarcinoma of the pancreas. The primary endpoint: To asses efficacy of siG12D LODER and local distribution in non-operable patients by histopathology measurements, local distribution by RNA analysis. To define the dose-limiting toxicities (DLT) The Secondary endpoint 1. To determine the recommended Phase II dose (RP2D) 2. To define and maximum tolerated dose (MTD) 3. In the event of surgery, assessment of siG12D LODER local distribution and efficacy will be based on histopathology measurements and RNA analysis. 4. Progression free survival - only by long term follow-up Conditions: Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer Intervention / Treatment: DRUG: siG12D LODER Location: Israel Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Phase 0: Provide written informed consent and be between the ages of 18 and up, inclusive. * Patient that is diagnosed as respectable locally pancreatic tumor * Have a target tumor accessible for intratumoral administration by EUS (Endoscopic Ultrasound) guidance as determined by the physician performing the EUS guided LODER insertion. * Have a Karnofsky performance status of ≥ 70%. * Have a life expectancy of \>= 3 months. * If female and of child-bearing potential, have a negative serum pregnancy test during screening. * Agree to use of a barrier method of contraception if sexually active (both men and women) from the time of administration of the first treatment and for at least 8 weeks after treatment. * Have serum creatinine \< 2.0 mg/dL, , PT, - INR \< 1.5 absolute neutrophil count (ANC) \> 1,000 x 103 cells/mL, platelets ≥ 75,000/mL, and hemoglobin \>= 10 mg/dL. * Have screening procedures completed within 2 weeks of starting treatment. * No other malignancy present that would interfere with the current intervention. * Have measurable disease. Phase I * Provide written informed consent and be between the ages of 18 and up. * Have an unresectable, locally advanced diagnosed or highly suspected adenocarcinoma of the pancreas. Or patients with a tumor and are not planed to undergo surgery due to a high surgical risk (e.g. coagulopathy or severe congestive heart failure). * Allocated to receive standard of care chemo as first line treatment. * Have a target tumor that is accessible for intratumoral administration by PTA or EUS guidance as determined by the radiologist/gastroenterologist performing the PTA/EUS injection. * Have a Karnofsky performance status of ≥ 70%. * Have a life expectancy of \>= 3 months. * If female and of child-bearing potential, have a negative serum pregnancy test during screening. * Agree to use of a barrier method of contraception if sexually active (both men and women) from the time of administration of the first treatment and for at least 8 weeks after treatment. * Have serum creatinine \< 2.0 mg/dL, PT - INR \< 1.5, absolute neutrophil count (ANC) \> 1,000 x 103 cells/mL, platelets ≥ 75,000/mL, and hemoglobin \>= 10 mg/dL. * Have screening procedures completed within 4 weeks of starting treatment. * No other malignancy present that would interfere with the current intervention. * Have measurable disease. Exclusion Criteria: Phase 0: * Have distant metastasis spread (such as liver or lung, or lymph nodes metastases), peritoneal spread or malignant sites. * Have clinically significant pancreatitis within 12 weeks of treatment. * If female, be breast feeding. * Have a medical condition contraindicated for both percutaneous- and endoscopic- guided delivery or any intercurrent medical illness or other medical condition that would in the judgment of the investigator compromise patient safety or the objectives of the study. * Have a history of bleeding coagulopathy. * Have participated in any therapeutic research study within the last 4 weeks. Phase I: * Have distant metastatic spread (such as liver, lung, or lymph nodes metastases), peritoneal spread or malignant sites. * Have clinically significant pancreatitis within 12 weeks of treatment. * If female, be breast feeding. * Have a medical condition contraindicated for both percutaneous- and endoscopic- guided delivery or any intercurrent medical illness or other medical condition that would in the judgment of the investigator compromise patient safety or the objectives of the study. * Have a history of bleeding coagulopathy. * Have participated in any therapeutic research study within the last 4 weeks.

Study Objectives Phase 1, Multiple Dose Study of MPC-6827 in Subjects with Refractory Solid Tumors. Conditions: Refractory Solid Tumors Intervention / Treatment: DRUG: MPC-6827 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: 1. Advanced or Metastatic Cancer 2. Measurable / Evaluable Disease 3. Karnofsky score greater than or equal to 70% 4. Adequate Hematology / Organ function 5. No Baseline peripheral or central neuropathy above grade 1 Exclusion Criteria: 1. Hypersensitivity to Cremophor EL 2. Pregnant or Lactating 3. Spinal Cord Compression 4. Pre-existing Dementia / Cognitive Disfunction 5. Require Neupogen or Neulasta to Maintain Neutrophil Count 6. Have Primary Brain Cancer 7. Have history of Ischemic Heart Disease 8. Have Diabetes

Study Objectives The purpose of this study is to ascertain whether treatment with lenalidomide or lenalidomide in combination with gemcitabine induces modulation of immune effector functions and to characterize the nature of immune functions. Conditions: Pancreatic Carcinoma Metastatic, Pancreatic Ductal Adenocarcinoma Intervention / Treatment: DRUG: Gemzar, DRUG: Revlimid Location: Sweden Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas. * ECOG performance status of 0 or 1, see Appendix 1. * Life expectancy \> 12 weeks. * Must understand and voluntarily sign an informed consent form. * Age \> 18 years at the time of signing informed consent form. * Must be able to adhere to the study visit schedule and other protocol requirements. * Female subjects of childbearing potential† must: * Understand that the study medication is expected to have a teratogenic risk * Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea * Male subjects must: * Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception. * Agree not to donate semen during study drug therapy and for one week after end of study drug therapy Exclusion Criteria: * Prior use of systemic chemotherapy for the treatment of adenocarcinoma of the pancreas (with the exception of gemcitabine, fluorouracil, or capecitabine in the adjuvant setting). * Laboratory abnormalities: * Prior history of malignancy within 5 years (except basal or squamous cell carcinoma or carcinoma in situ of the cervix or breast, localized prostate cancer with PSA \< 1,0 mg/dL). * Subjects with a history of or active DVT or PE that are not therapeutically managed on a stable dose of appropriate anticoagulant. * Brain metastases (subjects that are asymptomatic and do not require steroid control may be enrolled at the discretion of the investigator). * Surgery within 28 days prior to cycle 1 Day 1 (minimally invasive procedures for the purpose of diagnosis or staging of the disease are permitted, including stent placement and insertion of central venous access advice). * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent form. * Prior therapy with lenalidomide or thalidomide. * Use of any other experimental drug or therapy within 28 days prior to Cycle 1 Day 1. * Pregnant or lactating females.

Study Objectives The study is a prospective, single-arm, one-site therapeutic trial of the combination of trametinib plus digoxin for advanced melanoma. endpoints are toxicities assessed by nCi CTCae v4.1 within the first 8 weeks, responses measured by ReCiST v1.1 criteria every 8 weeks with scans and exams, tumor sensitivity to the drug combination quantified by tumor regressions in nSG mice, and correlations of response with tumor sensitivity, BRaF status, MaPK inhibitor exposure history, and tumor sodium pump expression. Treatment Dosage and administration Study Drugs: 1. Trametinib (2mg) will be administered orally on a daily basis. 2. Digoxin (0.25mg) will be administered orally on a daily basis. on a 8-week cycle, duration of treatment can last from 8 to 104 weeks. endpoints 1. Toxicities will be assessed via nCi's CTCae v4.1 toxicity criteria. DLTs will be defined based on the rate of drug-related (definitely or probably) grade 3-5 adverse events experienced within the first 8 weeks of study treatment. The MTD will be exceeded if more than 20% of patients on the study experience DLTs. 2. Responses will be measured by ReCiST v1.1 every 8 weeks. Response duration will be defined as time from first documented response until disease progression. PFS is time from treatment until disease progression. 3. Patient tumor sensitivity to the drug combination will be quantified by the amount of subcutaneous established tumor growth inhibition in nSG mice by 5d/week oral gavage with drugs. 4. Tumor nRaS status will be determined by tumor Dna extraction, PCR amplification of exons and Sanger sequencing of nRaS. 5. History of prior MaPK inhibitor therapies will document MeK inhibitor exposures. 6. Sodium pump subunit expression will be analyzed by pretreatment tumor immunohistochemistry and a qualitative 0 to 3+ grading system. Conditions: Melanoma Intervention / Treatment: DRUG: Trametinib (2mg)/Digoxin (.25mg) 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: * 1. Histologic diagnosis of unresectable or metastatic melanoma. For unknown primary disease, diagnosis of metastatic disease by cytology FNA is not acceptable. BRAF wild-type confirmed, and NRAS mutation assessed. 2. Age \> 18 years. 3. Any number of prior systemic therapeutic regimens for unresectable stage III or stage IV melanoma. This includes chemotherapy, immunotherapy, pathway inhibitors, biochemotherapy, or investigational treatments. Patients may also have received therapies in the adjuvant setting. 4. ECOG Performance status 0-2. 5. Adequate organ and marrow function as defined below: * leukocytes ≥ 2,000/mcL * absolute neutrophil count ≥ 1,000/mcL * platelets ≥ 75,000/mcl * total bilirubin \< 3 x institutional upper limit of normal * AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal * creatinine \< 1.5 mg/dL * cardiac ejection fraction \> 50% * QTc \< 480msec 6. 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 for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 7. All sites of disease must be evaluated within 4 weeks prior to beginning therapy. Patients must have measurable disease as defined by RECIST v1.1. 8. Ability to understand and the willingness to sign a written informed consent. 9. Patients must be willing to undergo tumor biopsy pretreatment and at relapse. Exclusion Criteria: 1. Subjects who have had chemotherapy or radiotherapy or any systemic therapy for melanoma within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. No concomitant therapy is allowed including IL2, interferon, ipilimumab, anti-PD-1 or anti-PD-L1 antibody, cytotoxic chemotherapy, immunosuppressive agents, or other investigational therapies. 2. Active infection with hepatitis B or C or HIV. 3. Subjects with active CNS disease are excluded. Patient with brain metastases previously treated with surgery or radiation therapy and with confirmed SD for \>4 weeks are allowed. 4. Patients are excluded if they have a history of any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix. 5. Uncontrolled inter-current 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. Cardiac symptoms or events within 24 weeks. 6. History of predisposition to retinal vein occlusion or central serous retinopathy. 7. Inability to assess BRAF or NRAS mutation status. Hypersensitivity to digoxin. 8. Wolff-Parkinson White syndrome or AV block or sinus node dysfunction.

Study Objectives This is an open-label, non-randomized, dose-escalation trial in patients with advanced solid tumors. The trial comprises 2 stages: a dose escalation stage at 8 dose levels of 2, 5, 10, 20, 40, 60, 80, and 100 mg/day,and possibly additional intermediate doses, to determine the MTD and recommended dose, and a subsequent 2 parts of expansion stage to investigate the safety profile and antitumor effect of OPB-51602 at the recommended dose. Conditions: Malignant Solid Tumour Intervention / Treatment: DRUG: OPB-51602 Location: Singapore Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with pathologically confirmed, locally advanced or metastatic solid tumors who are unresponsive to standard therapy or for whom standard therapy is intolerable or unsuitable * Age: ≥21 years (at time of informed consent) * ECOG performance status: ≤2 (Appendix 1) * Life expectancy of longer than 3 months * Adequate vital organ function as follows: 1. Bone marrow function Neutrophils: ≥1,500/μL, platelets: ≥75,000/μL, hemoglobin: ≥9.0 g/dL 2. Hepatic function Aspartate transaminase (AST) and alanine transaminase(ALT): ≤2.5 ×institutional upper limit of normal(ULN) or ≤5.0 × institutional ULN if there is liver metastasis, serum total bilirubin: \<2.5 × institutional ULN 3. Renal function Serum creatinine: \<1.5 × institutional ULN * Capable of swallowing OPB-51602 tablets * Ability to understand and willingness to sign written informed consent form (ICF) for participation in the trial * No chemotherapy, radiotherapy, surgery, immunotherapy, or other therapy within 4 weeks prior to start of investigational medicinal product (IMP) administration and recovered from any prior toxicity * If a subject has received more than 5 regimens of previous chemotherapy, the investigator must discuss with the sponsor regarding subject suitability prior to enrollment. Exclusion Criteria: * Uncontrolled central nervous system (CNS) metastasis * Uncontrolled concurrent illness, including active infection, angina pectoris, cardiac arrhythmia, or heart failure (NYHA class III or IV, Appendix 2 New York Heart Association (NYHA) functional classification) * Concurrent malignancy of a different type * Immunocompromised subjects, including those who are known to be infected with human immunodeficiency virus (HIV) * Psychiatric illness that would limit compliance with trial requirements * Pregnant or breast-feeding women * Women of childbearing potential (WOCBP) or male subjects whose partners are WOCBP who cannot or will not use effective contraceptive measures * Administration of another investigational agent within 6 weeks prior to start of IMP administration * Use of any of the prohibited medications and other substances listed in Appendix 3 CYP3A4 Inhibitors and Inducers within either 1 week prior to start of IMP administration or a period of at least 5 times the respective elimination halflife, whichever is longer * Known severe gastrointestinal disorder, including malabsorption (at screening) * Patients with CTCAE Grade 1 or higher pneumonitis (interstitial pneumonia) or pulmonary fibrosis\* \* If interstitial lung abnormalities, (e.g. ground-glass or linear opacity) are suspected on chest CT scan (high-resolution CT), regardless of whether or not there are any accompanying symptoms it must be confirmed, such as through consultation with a respiratory or radiology expert if necessary, that the patient dose not fall under this exclusion criterion before the patient can be enrolled in the trial.

Study Objectives The purpose of this trial is to evaluate the efficacy of lanreotide on locally evolving and/or metastatic MCC in a national prospective multicentre phase II study (centres belonging to the skin cancer task force of the French Society of Dermatology namely "Groupe de Cancérologie Cutanée de la Société Française de Dermatologie"). This one-arm study, for which the primary endpoint is overall response to lanreotide, will follow an A'Hern plan in one step (A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med 2001, 20:859-66) with main evaluation at 12 weeks on a population of 35 patients. The investigators make assumption that a 40% success rate at 3 months would be desirable, but if it was 20% or less the treatment would be unacceptable. It gives a trial size of 35 patients with a cut-off of 12 patients. Over 12 patients lanreotide will be considered as effective. The lanreotide treatment (Somatuline LP 120 mg injected subcutaneously every 28 days) will be provided by IPSEN Pharma laboratory. An ancillary immunohistochemistry study on somatostatine receptors 2,3,5, dopamine receptors 1,2 and polyomavirus MCPyV will bring new data on this neuroendocrine tumour and potentially provide new therapeutic perspectives. The results of this study may : * determine whether somatostatin analogues may help to treat locally advanced and/or metastatic MCC; * address whether there is a correlation between positive SPECT-CT (octreoscan) assessment and therapeutic response to lanreotide; * evaluate the place of TEP-CT and SPECT-CT for MCC evaluation/staging; * evaluate in future studies, with the ancillary data, other analogues or hybrid molecules; * consider, if positive results are obtained from this study, somatostatin analogues as adjuvant treatment after surgery of primary MCC. Conditions: Carcinoma, Merkel Cell Intervention / Treatment: DRUG: Lanreotide Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed neuroendocrine carcinoma of the skin (Merkel cell carcinoma) with inoperable local-regional disease or distant metastatic disease (stages IIIB or IV AJCC 2010), cerebral nervous system metastases will be allowed. * First line of treatment or more * Measurable disease: at least 20 mm by conventional techniques or 10 mm by spiral CT scan * WHO performance status ECOG 0-3 * premenopausal patients must use effective contraception * No other prior malignancy within 5 years except adequately treated basal cell or squamous cell carcinoma or in situ cancer of the cervix * No other concurrent chemotherapy, immunotherapy or hormone therapy. * At least 4 weeks since adjuvant chemotherapy, 14 days since radiotherapy and 2 weeks since surgery * Biological functions: absolute neutrophil count at least 1000/mm3, platelet count at least 100000/mm3, haemoglobin at least 9g/dl (transfusion allowed), bilirubin no greater than 3 times upper limit of normal (ULN), SGOT and SGPT no greater than 2.5 times ULN, no untreated chronic liver disease, creatinine no greater than 1.5 times ULN, no untreated chronic renal disease, no untreated diabetes or infection * Written informed consent Exclusion Criteria: * previous hypersensibility to lanreotide treatment * complicated and untreated cholelithiasis * pregnancy or breast-feeding * patient treated with cyclosporine

Study Objectives RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of liposomal vincristine in treating patients who have refractory or relapsed non-Hodgkin's lymphoma. Conditions: Lymphoma Intervention / Treatment: DRUG: liposomal vincristine sulfate Location: Canada, United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: * Histologically confirmed aggressive non-Hodgkin's lymphoma including: * Peripheral T-cell lymphoma not otherwise specified * Anaplastic large null-/T-cell lymphoma * Diffuse large B-cell lymphoma including: * Primary mediastinal large B-cell lymphoma with sclerosis * Intravascular large B-cell lymphoma * Immunoblastic B-cell lymphoma * T-cell-rich B-cell lymphoma * Anaplastic large B-cell lymphoma * At least one bidimensionally measurable lesion with clearly defined margins at least 2 cm in the largest dimension by physical examination or CT scan * No prior or active CNS lymphoma or AIDS-related lymphoma * Must have received 2 or more prior chemotherapy courses from time of diagnosis of aggressive lymphoma or from time of biopsy-proven transformation from indolent to aggressive * Prior first and second-line therapy must have been combination chemotherapy * Prior first-line chemotherapy regimen must have contained anthracycline * Must have had at least a minor response to first-line therapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-3 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 500/mm\^3 (unless due to lymphoma bone marrow involvement) * Platelet count at least 50,000/mm\^3 (unless due to lymphoma bone marrow involvement) Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * ALT no greater than 4 times ULN * Alkaline phosphatase no greater than 4 times ULN Renal: * Not specified Neurologic: * No prior neurological disorders unrelated to chemotherapy (including familial neurological diseases or acquired demyelinating disorders) * No neuromuscular impairment (neuromotor, neurosensory, or neurocerebellar) * No prior grade 3 or 4 sensory or motor neuropathy related to chemotherapy Other: * No uncontrolled severe medical illness or infection * HIV negative * No other malignancies within the past 5 years except curatively resected basal cell skin cancer or carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Radiotherapy * No prior allogeneic bone marrow or peripheral blood stem cell transplantation * At least 4 weeks since prior immunotherapy * No concurrent biological agents Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy Endocrine therapy: * At least 4 weeks since prior corticosteroids at a dose greater than 10 mg/day of prednisone or equivalent Radiotherapy: * Prior involved-field radiotherapy allowed if irradiated area is not the only source of measurable disease * Prior total body radiotherapy with high-dose therapy and autologous stem cell transplantation allowed * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy to any disease site Surgery: * At least 4 weeks since prior major surgery except for diagnosis of lymphoma * No concurrent surgical removal of any indicator lesion Other: * At least 4 weeks since prior alternative or investigational anticancer treatment * No other concurrent systemic anticancer therapy * No other concurrent investigational drug * No concurrent phenytoin * No concurrent hepatic drug metabolism inhibitors or inducers (cytochrome P450 isoenzymes in the CYP 3A subfamily)

Study Objectives RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-2 following bone marrow transplantation in treating patients who have hematologic cancer at risk of relapse. Conditions: Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm Intervention / Treatment: BIOLOGICAL: aldesleukin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: Any of the following diagnoses eligible: Acute myelogenous leukemia beyond first complete remission Acute lymphoblastic leukemia Chemotherapy resistant non-Hodgkin's lymphoma Chemotherapy resistant Hodgkin's disease Multiple myeloma Primary refractory acute leukemia Secondary leukemia Chronic myelomonocytic leukemia No chronic myelogenous leukemia, aplastic anemia, or myelofibrosis HLA identical related donor required PATIENT CHARACTERISTICS: Age: 0.5 to 65 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characterisitics Hepatic: Bilirubin less than 2.5 mg/dL (unless Gilbert's syndrome present) Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No active congestive heart failure, arrhythmia, or angina pectoris No myocardial infarction within past 12 months Pulmonary: No requirement for oxygen Other: Afebrile for greater than 48 hours No active, serious infection (e.g., sepsis, mucormycosis, or uncontrolled aspergillosis) No debilitating medical or psychiatric illness that would preclude compliance Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplant Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified

Study Objectives This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment. Conditions: Advanced Malignant Tumors Lymphomas Intervention / Treatment: BIOLOGICAL: IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: 1. Subjects with histologically/cytologically confirmed unresectable or metastatic solid tumors or relapsed/recurrent lymphomas for which there are no available therapies known to confer clinical benefit. 2. At least one evaluable lesion in Part A or at least one measurable lesion in Part B. 3. Male or female subject \> 18 years old. 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 5. Must have adequate organ function including the following. 6. Subjects with life expectancy ≥ 12 weeks. 7. Female subjects of childbearing age or male subjects whose partners are women at childbearing age, need to use 2 highly effective contraceptive measures, including one barrier method, throughout the treatment period and 6 months after the treatment period. 8. Willing to sign informed consent form and be able to comply with the study's rules and visits/related procedures. Exclusion Criteria: 1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein. 2. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies. 3. Subjects who are on anticoagulants and/or require concomitant aspirin or other nonsteroids anti-inflammatory medications. 4. Subjects who have a history of blood transfusion within 2 weeks prior to screening, or the use of erythropoietin (EPO), granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage-colony stimulating factor (GM-CSF), thrombopoietin (TPO) or IL-11 therapy. 5. Subjects who received the last dose of antineoplastic therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization) within 4 weeks prior to the first dose of study drug. Subjects who received the last dose of radiotherapy within 3 weeks prior to the first dose of study drug. 6. Subjects that received immunosuppressive drugs within 7 days prior to the first dose of study drug, excluding topical, intra-nasal, or inhaled glucocorticoids or systemic glucocorticoids (i.e. equivalent to no more than 10 mg prednisone/day) or other glucocorticoids of equivalent dosage through nasal spray, inhalation or other routes. 7. Any ongoing AEs Grade 2 or higher as per NCI CTCAE v5.0 directly attributed to prior anti-tumor treatment with the exception of residual hair loss and fatigue 8. Subjects who received whole pelvic radiotherapy prior to the enrollment. 9. Subjects with known cerebrospinal metastases and other known central nervous system metastases. 10. Subjects with active or suspected autoimmune diseases or with a history of documented autoimmune disease over the past 2 years (subjects can be included in the study: vitiligo, psoriasis, alopecia or Grave's disease subjects who do not require systemic treatment within 2 years; hypothyroidism subjects who require only thyroid hormone replacement therapy, and type I diabetes subjects who require only insulin replacement therapy). 11. Known history of primary immunodeficiency. 12. Known history of active pulmonary tuberculosis. 13. Known history of allogenic organ transplantation and hematopoietic stem cell transplantation. 14. Known history of hypersensitivity to any components of the IBI322 injection.

Study Objectives This study will test if local therapies in addition to erlotinib can improve responses and delay the time until new treatment is required. This study will also collect blood samples for research blood tests. Conditions: Oligometastatic Lung Adenocarcinoma Intervention / Treatment: DRUG: Erlotinib, OTHER: Local Therapies Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Newly diagnosed metastatic lung adenocarcinoma (recurrent or de novo) harboring sensitizing EGFR mutations (L858R, exon 19 deletion, G719A, L861Q, S768I, exon 19 insertions) with oligometastatic disease (≤5 discrete lesions of disease irrespective of location, inclusive of the primary lesion): * all sites of disease must be amenable to definitive treatment with a local therapy (surgical resection, stereotactic radiosurgery, ablation and conventional radiation therapy) as determined by surgery, interventional radiology and radiation oncology * all intrathoracic lymph nodes (including hilar, mediastinal, and supraclavicular nodal disease) are considered 1 discrete lesion. * Each brain metastasis is included as a distinct lesion. * Patients already started on erlotinib are eligible as long as their sites of disease are determined to be eligible for definitive local therapy by consensus of the principal investigators within 12 weeks of the patient first taking erlotinib. * Lung adenocarcinoma histology confirmed at MSKCC. * Available archived tissue to perform molecular analysis * Patients without available archived tissue can have repeat biopsies to determine EGFR status as per standard clinical care guidelines * Age 18 years or older * Karnofsky Performance Status ≥ 70% * Adequate bone marrow, liver and renal function, as specified below: * Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L * Hemoglobin ≥ 8 g/dL * Platelets ≥ 100 x 109/L * Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's Syndrome) * AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present * Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal. * For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment * Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter Exclusion Criteria: * Treatment with erlotinib prior to developing metastatic disease * Patients with activating but not sensitizing mutations (exon 20 insertions, EGFR T790M) * Malignant pleural effusion or pleural disease * Leptomeningeal disease * Any site of disease that is not amenable to definitively local therapy including surgery or radiation therapy * Women who are breastfeeding or pregnant * Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment. * Any medical co-morbidities that would preclude surgery or radiation therapy

Study Objectives The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for unresectable locally advanced pancreatic adenocarcinoma. Conditions: Pancreatic Cancer Intervention / Treatment: DRUG: Gemcitabine, DRUG: Nab-Paclitaxel Location: Japan 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 advanced pancreatic cancer * Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery) * Performance Status:0-1(ECOG) * Patients of age =\>20 and 75\> * White Blood Cell (WBC) \>=3,500/mm3,12,000/mm3, * Neutrophils \>=1,500/mm3, platelets=100,000/mm3, * Hemoglobin \>=9.5 g/dl, * GOT \</=2.0 X Upper Limit Number (ULN), * Glutamate Pyruvate Transaminase (GPT) \</=2.0 X ULN, * Alkaline Phosphatase (ALP) \</=2.0 X ULN, * Total bilirubin \<=1.5mg/dl, * Serum creatinine \<=1.2mg/dl, * Creatinine clearance\>=50 ml/min * arterial O2 pressure (PaO2) \>=70torr or arterial O2 saturation (SpO2) \>=96% * Life expectancy more than 3 months. * Written informed consent. Exclusion Criteria: * Active infection * Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT * Severe complication (heart disease, cirrhosis, diabetes) * Myocardial infarction within 3 months * Active synchronous or metachronous malignancy * Pregnant or lactation women, or women with known or suspected pregnancy * Symptomatic brain metastasis * History of severe drug allergy * Peripheral neuropathy * Patients who are judged inappropriate for the entry into the study by the investigator

Study Objectives In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Thalidomide Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Stage II or III multiple myeloma according to Durie and Salmon criteria. * Patients between 65 and 75 years of age * Previously untreated patients Exclusion Criteria: * Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma) * Primary or associated amyloidosis * World Health organisation performance index of at least 3 * Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more * Cardiac or hepatic dysfunction * Cerebral circulatory insufficiency * Absolute contraindication to corticosteroids * Peripheral neuropathy * HIV or hepatitis B or C positivity * Patients who had geographic, social or psychological conditions which might prevent adequate follow-up

Study Objectives In this study, the researchers will conduct interviews with melanoma patients to describe the sun exposure and sun protection practices of patients and their children. The researchers will use the findings of this interview study to develop a salient intervention targeted to the needs of melanoma patients and their children. The researchers will evaluate the intervention in a randomized, controlled trial. The specific aims of this study are: * To interview 210 melanoma patients with children 12 years of age or younger to describe patients' socio-cognitive and psychological factors, describe patients' and children's sun exposure and sun protection practices, and identify determinants of patients' and children's sun exposure and protective practices. * To develop a targeted behavioral intervention that is designed to increase patients' protective practices to reduce their children's sun exposure, increase patients' self-protective practices, decrease the sun exposure levels of patients and their children, and positively influence socio-cognitive and psychological determinants of child-centered and self-protective practices. * To conduct a randomized, controlled trial in a sample of 360 melanoma patients with children 12 years of age or younger to evaluate the targeted behavioral intervention consisting of print and video materials. The intervention will be assessed for its effects on: 1) child sun exposure and sun protection; 2) patients' protective practices to reduce their children's sun exposure; 3) patients' sun exposure and self-protective practices; and 4) patients' socio-cognitive and psychological factors that facilitate behavior change. Conditions: Melanoma Intervention / Treatment: BEHAVIORAL: Interview Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: 1. Melanoma patients are eligible if they were diagnosed with in situ, localized, or microscopic stage III melanoma after January 1, 1988. 2. Melanoma patients are eligible if they are the parent of a child 12 years of age or younger and reside with the child. 3. Melanoma patients are eligible if they provide informed consent. 4. Melanoma patients are eligible if they are 18 years of age or older. 5. Melanoma patients are eligible if they are able to speak, read, and write English. 6. Melanoma patients are eligible if they meet all inclusion criteria. Exclusion Criteria: 1) Melanoma patients are not eligible if they cannot provide informed consent.

Study Objectives The purpose of this study is to assess the safety and performance of the HydroMARK Breast Biopsy Site Marker manufactured in the Devicor Medical Products, Inc. Tijuana facility. Conditions: Breast Cancer Intervention / Treatment: DIAGNOSTIC_TEST: Ultrasound imaging Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: Safety Cohort * Subject was implanted during a breast biopsy procedure with a HydroMARK Breast Biopsy Site Marker manufactured at the Devicor Tijuana facility per the instructions for use * Subject has been followed at least 90 days according to the hospital's standard of care (SOC) * Subject was ≥ 18 years of age at the time of the breast biopsy procedure * Subject has accessible medical records documenting the breast biopsy procedure including, at minimum: age, sex, primary diagnostic indication and documentation of device-related adverse events which occurred, if any Performance Cohort * Subject was implanted during a breast biopsy procedure with a HydroMARK Breast Biopsy Site Marker manufactured at the Devicor Tijuana facility per the instructions for use * Patient is ≥18 years of age * Patient has provided informed consent to participate in study, including follow-up visit for ultrasound imaging at 6-12 weeks post-biopsy Exclusion Criteria: Safety Cohort • Biopsy area was infected at the time of implant Performance Cohort * Contraindication to HydroMARK Breast Biopsy Site Marker implantation * Biopsy area is infected at the time of implant * Patient has a breast biopsy marker (in the same breast) implanted from a previous procedure

Study Objectives Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. Conditions: Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Stage III Uterine Corpus Cancer, Stage IV Uterine Corpus Cancer Intervention / Treatment: DRUG: Doxorubicin Hydrochloride, DRUG: Cisplatin, RADIATION: Radiation Therapy 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 confirmed endometrial cancer including 1 of the following subtypes: * Clear cell carcinoma * Serous papillary carcinoma * Endometrioid adenocarcinoma * Stage III or IV disease * Positive adnexa * Metastases to serosa, bowel mucosa, abdomen * Positive pelvic or paraaortic nodes * Positive pelvic washings or vaginal involvement within the radiation port * Tumor must be surgically reduced to 2 cm or less within 8 weeks of study entry * Must have had a hysterectomy and bilateral salpingo oophorectomy * No recurrent disease * No distant metastases outside of abdominopelvic area, including: * Parenchymal liver metastases * Lung metastases * Positive inguinal lymph nodes * Positive supraclavicular nodes * Pleural effusion with malignant cytology * Performance status - GOG 0-2 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT and alkaline phosphatase no greater than 3 times ULN * Creatinine no greater than ULN * Cardiac ejection fraction greater than 50% * No other prior or concurrent malignancy within the past 5 years except nonmelanoma skin cancer * No prior chemotherapy * No prior pelvic or abdominal radiotherapy * No prior radiotherapy for other prior malignancy

Study Objectives We propose to test, by DNA linkage analysis of family pedigree members, the following interrelated hypotheses: 1) that sexual orientation is genetically influenced; 2) that the development of Kaposi's sarcoma and other outcomes of HIV infection in male homosexuals is affected by host susceptibility genes, circulating sex hormone levels, or HLA haplotype; and 3) that alcoholism and other psychobehavioral conditions are associated with homosexuality on a genetic basis and/or influenced by candidate behavioral loci. The subjects for these studies will be self-identified male and female homosexual probands and their relatives from families in which there are at least two individuals with homosexual orientation. All subjects will be adults, and will be referred through NIH physicians, private practitioners, and gay and lesbian organizations. Subjects will undergo a sexual orientation and behaviors interview, a psychiatric interview, and phlebotomy for HIV testing, HLA determination, endocrine measurements, and preparation of DNA from cultured lymphocytes. The DNA samples will be analyzed for a series of genetic markers that span the human genome and for candidate loci chosen for function. Conditions: Alcoholism, HIV Infection, Homosexuality, Kaposi's Sarcoma Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

INCLUSION CRITERIA: The basic criterion for entering families into the DNA linkage study is the presence of two or more homosexual siblings of the same sex. Additional criteria will be imposed depending on the aims of the particular project.

Study Objectives Adjuvant radiotherapy after breast-conserving surgery for breast cancer reduces the risk of locoregional relapse and ensures better overall survival. In recent years it has been found that hypofractionation in which the number of radiation sessions is reduced with a higher dose per session offers advantages for breast irradiation. Randomized studies showed that moderate hypofraction regimens in 15 or 16 fractions have the same effect in tumor control and toxicity, although the total dose is lower than the traditional 50 Gy in 25 fractions. In a randomized study from the United Kingdom (START-B trial) even a better disease-free survival was seen with 15 sessions than with 25 sessions and the long-term side effects were also less with the short schedule. This project proposes a clinical trial with an accelerated radiotherapy schedule in 5 sessions. It is expected that the accelerated schedule of 5 sessions over 12 days will have a number of radiobiological benefits: since a higher dose per session is given over a shorter period of time, it is expected that tumor control and survival will be higher. By reducing the total treatment time, the total dose is reduced, which may result in fewer radiation-related side effects and thus improve the quality of life. Apart from these radiobiological benefits, the shorter radiotherapy program reduces the number of treatment days from 15 to 5. This is not only more comfortable for the patients, but also increases the treatment capacity of the radiotherapy department. This opens up a possibility for the use of more complex techniques with fewer side effects such as radiation in the prone position. This project includes a randomized study comparing the accelerated schedule in 5 sessions with a hypofraction schedule of 15 sessions in patients who are irradiated on the entire breast after breast-saving surgery. The primary endpoint is chest retraction (loss of volume) 2 years after radiotherapy. Conditions: Breast Cancer Intervention / Treatment: RADIATION: Radiation Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * female patients with non-metastatic breast cancer, * age ≥ 18 years, * breast conserving surgery, * multidisciplinary decision of adjuvant breast irradiation, * informed consent obtained, signed and dated before specific protocol procedures Exclusion Criteria: * lymph node metastases, * distant metastases, * bilateral breast irradiation, * history of previous radiation treatment to the same region * life expectancy of less than 2 years, * planned reconstructive surgery, * conditions making toxicity evaluation difficult (e.g. skin disorders), * inability to respect constraints on organs at risks * patients unlikely to comply with the protocol

Study Objectives Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer. Conditions: Obstructive Jaundice, Pancreatic Cancer Intervention / Treatment: PROCEDURE: Metal stent, PROCEDURE: Plastic stent Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patients with pancreatic cancer and mass in the head of pancreas causing jaundice. * Patients 19 yrs of age and older * Serum bilirubin \> 2mg/dl * CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin). Exclusion Criteria: * Karnofsky score \< 60 * Prior (ERCP or PTC) attempts at biliary decompression for the same indication * Tumor-related gastric outlet obstruction (vomiting and oral intake of \< 1L/day) * Ongoing or planned neoadjuvant therapy * Cholangitis at presentation or coagulopathy needing reversal medication * Post-surgical anatomy * Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum * Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).

Study Objectives Primary objective : To compare the combination of S-1 and oxaliplatin(SOX) to the combination of capecitabine and oxaliplatin(COX) therapy for advanced or metastatic colorectal carcinoma. Secondary objectives : 1. To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups. 2. To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: S-1 & Oxaliplatin, DRUG: Capecitabine & Oxaliplatin Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically documented colorectal adenocarcinoma * Age over 18 years old * Performance status (ECOG scale): 0-2 * Measurable or evaluable disease * Patients can take food and drugs orally * Adequate organ functions * Life expectancy ≥ 3 months * Patients should sign a written informed consent before study entry Exclusion Criteria: * Tumor type other than adenocarcinoma * Second primary malignancy * Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic colorectal cancer * Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease has been completed within 6 months prior to initiation of study treatment. * Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization. * Presence of CNS metastasis * Obvious peritoneal seeding or bowel obstruction disturbing oral intake * Symptomatic peripheral neuropathy * Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. The patient received curative operation or RFA for metastatic disease. * Serious illness or medical conditions * Receiving a concomitant treatment with drugs interacting with S-1, capecitabine or oxaliplatin, as follows;flucytosine, a fluorinated pyrimidine antifungal agent phenytoin warfarin etc. * Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug. * Pregnant or lactating woman * Women of child bearing potential not using a contraceptive method * Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential * Any patients judged by the investigator to be unfit to participate in the study

Study Objectives Improved cancer survival has led to increased attention on long-term health and quality of life (QoL) among the survivors. Both the cancer diagnosis and intensive treatments increase the risk of late effects which may interfere with daily physical, psychological and social functioning, and thereby negatively affect their QoL. Well-documented late-effects among cancer survivors are second cancer, cardio-vascular disease, pain, hormone disturbances, mental distress and chronic fatigue (CF). CF is a subjective experience of substantial lack of energy, exhaustion and cognitive difficulties lasting for six months or longer. CF is one of the most common and distressing late effects after cancer, affecting 15-35 % of survivors, often for years beyond treatment. Despite the high prevalence and the huge negative consequences of CF on daily functioning and QoL and the economic and societal costs, effective treatment of CF and standardized follow-up care are currently lacking. CF is a complex condition best understood as a multifactorial phenomenon. Our and other research groups have examined various cohorts of cancer survivors in order to identify behavioral-, psychological-, and biological factors associated with CF, that can form the basis for targeted interventions. So far, few treatable biological factors have been identified, even though immune activation, flattened diurnal cortisol slopes and a blunted cortisol response to stress have been demonstrated in small studies among cancer survivors suffering from CF. On the other hand, several modifiable behavioral factors including emotional distress, physical inactivity, sleep disturbances and unhealthy diets are found to be associated with CF. So far, most of the interventions aiming to reduce fatigue during and shortly after cancer treatment have targeted only one of these factors at a time, with small to moderate effect sizes. No prior study has examined if CF in cancer survivors is better treated by a complex intervention targeting combinations of these factors, an approach which seems logical due to the complexity of the symptom. The Division of Cancer Medicine at Oslo University Hospital (OUH) presently offers limited rehabilitation programs, including patient education, physical exercise, cognitive behavioral program and nutrition counselling to cancer survivors with CF. However, these programs are not offered as an interdisciplinary intervention integrated in a standardized patient care pathway, and the effects of these interventions have not been assessed. Based on the investigators clinical experience and published studies on single-targeted interventions, the investigators hypothesize that a complex intervention including psycho-educational elements, physical exercise and nutrition counseling delivered as a standardized patient care pathway is well-founded and doable, and will improve fatigue, functioning and QoL in cancer survivors with CF. During the fall of 2021, the investigators will conduct a randomized controlled trial (RCT) with the overall objective to improve fatigue in lymphoma survivors with CF. To uncover strengths and weaknesses with the planned RCT, i.e. the inclusion procedures, the assessments and the complex intervention, the investigators are now conducting a small one-armed feasibility study before the RCT during spring 2021. Conditions: Fatigue, Lymphoma Intervention / Treatment: OTHER: A 12-week interdisciplinary complex intervention Location: Norway Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Seven lymphoma survivors will be included, with the same inclusion criteria as in the planned RCT: Inclusion Criteria: * Survivors of Hodgkin and aggressive non-Hodgkin lymphoma, diagnosed 2014 or 2019 (n=7) * 18-65 years at diagnosis, and 19-67 years at participation. * CF measured by Chalder FQ. * Curatively treated, more than 2 years since last treatment. * Participation approval from oncologist. Exclusion Criteria: * Indolent non-Hodgkin lymphoma. * Fatigue more than one year before the cancer diagnosis. * Ongoing cancer treatment, relapse or second cancer, somatic/physical conditions (i.e. severe heart failure/disease, lung disease, use of wheelchair /crutches). * Psychiatric disorders (i.e. severe depression, schizophrenia), substance abuse disorder. In addition, eight cancer survivors with various diagnosis, will be included from a waiting list for rehabilitation at the Cancer Rehabilitation Centre at Aker hospital.

Study Objectives The primary aim of this study is to continue the investigation of cone beam computed tomography (CBCT) for breast imaging already underway in the diagnostic setting by providing a compelling body of evidence incorporating non-contrast CBCT in the study protocol. The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions. Conditions: Breast Cancer Intervention / Treatment: DEVICE: Computed Tomography, DEVICE: Computed Tomography Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: Group I: * Females at least 35 years of age of any ethnicity * Had a mammogram, read as BI-RADS® 1 or 2 * Will undergo study imaging no later than four weeks from date of mammogram. * Is able to undergo informed consent. Group II: * Females at least 35 years of age of any ethnicity * Require diagnostic imaging * Will undergo study imaging no later than four weeks from date of diagnostic mammogram * Is able to undergo informed consent Exclusion Criteria: Group I and Group II: * Pregnancy * Lactation * Subjects with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker. * Subjects who are unable to tolerate study constraints. * Subjects who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) * Treatment for enlarged thymus gland as an infant * Irradiation for benign breast conditions, including breast inflammation after giving birth * Treatment for Hodgkins disease * Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. * Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) * Tuberculosis * Severe scoliosis

Study Objectives Analysis of safety, tolerability, and PK data will provide information that will guide future development of AB0024. Conditions: Neoplasms Intervention / Treatment: DRUG: AB0024 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 advanced malignant solid tumor that is refractory to, intolerant of, or for which no standard of therapy is available * Measurable or evaluable disease * ECOG Performance Status of ≤2 * No known active central nervous system (CNS) tumors or CNS metastases * Adequate organ function Exclusion Criteria: * Myocardial infarction within the last 6 months of study Day 1, symptomatic congestive heart failure (New York Heart Association Classification \> Class II), unstable angina, or unstable cardiac arrhythmia requiring medication * History of surgery within 28 days prior to enrollment or anticipated surgery during the study period * Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 28 days of study Day 1 (six weeks for nitrosoureas, mitomycin C, antibodies, or molecular agents with t½ \>10 days); (concurrent use of hormone therapy for breast or prostate cancer is permitted) * Treatment with immune modulators including, but not limited to, cyclosporine and tacrolimus within two weeks prior to enrollment * Concurrent or prior (within 30 days of study Day 1) anticoagulation therapy; (low-dose warfarin \[\<2 mg/day\] for prophylaxis against central venous catheter thrombosis is allowed) * Patient with tumor that is infiltrating or invading a major blood vessel

Study Objectives This study will explore new screening methods for early detection of breast and ovarian cancer in women at high risk for these diseases, because they have an altered breast cancer 1 (BRCA1) or breast cancer 2 (BRCA2) gene. It will also try to determine if breast tissue characteristics in women with a BRCA1 or BRCA2 mutation differ from those in women with a normal gene. Premenopausal women between 25 and 45 years of age who have participated in National Cancer Institute studies for families or individuals at high genetic risk of cancer (78-C-0039 or 99-C-0081) and who have at least a 50 percent probability of carrying an altered BRCA1 or BRCA2 gene may be eligible for this study. At the first visit, participants will have from 4 to 24 tablespoons of blood drawn and will be interviewed about breast and ovarian cancer risk factors, family and personal history of cancer, history of pregnancies, use of oral contraceptives and other hormones and drugs, and previous surgery on the breasts and ovaries. In addition, they will undergo the following procedures: Routine breast and ovarian cancer screening for high-risk women, including a mammogram, breast and pelvic exam, instruction in breast self-examination, CA 125 blood test and transvaginal ultrasound of the ovaries. Magnetic Resonance Imaging (MRI) of the breast MRI uses a strong magnetic field to show structural and chemical changes in tissues. Breast Duct Lavage In this procedure samples of fluid and cells from the lining of the breast milk ducts are collected to look for cancerous or pre-cancerous cell changes. Positron Emission Tomography (PET) scan PET scanning will be done only in participants whose mammogram or MRI findings require additional evaluation. This diagnostic test is based on differences in how cells take up and use glucose (sugar), one of the body s main fuels. Annual follow-up visits will be scheduled for 3 years and will include routine high-risk screening as described above, blood draw, update of family history and risk factors, breast MRI, breast duct lavage and, if there are changes on the MRI or mammogram that need further evaluation, the PET will be repeated. Conditions: Breast Cancer Intervention / Treatment: DRUG: 2-Fluorodeoxyglucose Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

* INCLUSION CRITERIA - Annual Follow-up Study: To participate in the Annual Follow-up Study, a woman must: Be at least 25 years of age (or 5 years younger than the age at diagnosis of the youngest family member with a tumor associated with the Breast-Ovarian Cancer Syndrome) and less than 56 years of age. Must be: A known BRCA1 or BRCA2 deleterious mutation carrier OR A first- or second- degree relative of an individual known to carry a deleterious BRCA1 or BRCA2 mutation OR A first- or second- degree relative of an individual with a tumor associated with the Breast-Ovarian Cancer Syndrome in a family with a known BRCA mutation. Have undergone genetic counseling and risk assessment. Agree to release of genetic test result for stratification purposes, whether or not she has chosen to receive individual test results for clinical decision-making. Have an ECOG performance status of 0-1. Be able to provide informed consent. Have at least one non-irradiated breast. EXCLUSION CRITERIA - Annual Follow-up Study: Any of the following will result in exclusion from the Annual Follow-up Study: Pregnancy or lactation within 6 months of enrollment. Abnormal CA-125 level. Bilateral breast cancer, ovarian (any stage) or breast cancer (Stage IIB or worse) unless relapse free for 5 years prior to the time of enrollment. Patients with DCIS, Stage I and Stage II breast cancer are eligible provided that it has been at least 6 months from the completion of primary therapy (surgery, radiation, and chemotherapy as applicable). Tamoxifen and aromatase inhibitor adjuvant therapy is allowed. Patients with DCIS, Stage I and Stage II breast cancer who have had a local relapse after primary treatment are not eligible unless they have been relapse free for 5 years prior to the time of enrollment. History of other invasive cancer unless relapse free for 5 years prior to the time of enrollment. Non-Melanoma skin cancer or cervical carcinoma in situ are excepted. Previous bilateral mastectomy or bilateral radiation therapy. Weigh over 136 kilograms. Allergy to gadolinium. Allergy to lidocaine or Marcaine (bupivacaine). (excluded from breast duct lavage only). Subareolar or other surgery of the breast to be studied which might disrupt the ductal systems. For example, papilloma resection, biopsy or fine needle aspirations (FNAs) within 2 cm of the nipple might disrupt the ductal systems. Biopsies or FNAs greater than 2 cm from the nipple are acceptable. (Excluded from ductal lavage only) A breast implant or prior silicone injections in the breast to be studied. (Exclude from breast ductal lavage only) Active infections or inflammation in a breast to be studied. (breast ductal lavage only) Medical or psychiatric disorder which, in the opinion of the Principal Investigator, would preclude informed consent or ability to participate in clinical research.

Study Objectives The aim of this study is to evaluate the feasibility and acceptability of the model of delivering CHW-driven home-based comprehensive NCD control services aimed to prevent premature deaths from cardio-vascular diseases, stroke and breast, cervix and oral cancers in the hard-to-reach women. Conditions: Cardio-vascular Disease, Stroke Cancer, Breast Cancer, Oral Cancer, Cervical Cancer Intervention / Treatment: DIAGNOSTIC_TEST: Evaluation of social, cultural and behavioral factors, DIAGNOSTIC_TEST: Evaluation of the feasibility and acceptability of delivery of early detections services Location: India Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SCREENING Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Women between 30 to 60 years residing in the villages of the Gogunda block in the district of Udaipur in Rajasthan, India, will be eligible to participate. Exclusion Criteria: * Women suffering from debilitating illnesses, pregnant women and women refusing to participate will be excluded.

Study Objectives Proper staging of Lung cancer is of paramount concern when determining a treatment regime. Currently the assessment of surgical candidacy is performed with the staging process, mainly the mediastinoscopy. A mediastinoscopy has the ability to access samples of the paratracheal lymph node stations (Levels 2R, 2L, 3, 4R, 4L), as well as the anterior subcarinal lymph node station (Level 7). In comparison, the EBUS-TBNA technique is a real-time procedure that has the potential to access the same paratracheal and subcarinal lymph node stations associated with the mediastinoscopy, but also extending out to the hilar lymph nodes (Levels 10 and 11). Because of the possibility of extended sampling range and a reduction in procedural invasiveness, EBUS-TBNA may represent a more efficient patient centered alternative to mediastinoscopy in the staging of lung cancer patients. Additionally, patients who are have lymph nodes in the N2 region frequently undergo chemotherapy and/or radiotherapy prior to surgery. Assessment of the lymph nodes after chemo/radiation is done using CT scans, as re-mediastinoscopy is a technically difficult procedure. These patients may benefit from EBUS-TBNA. Conditions: Non-small Cell Lung Cancer Intervention / Treatment: PROCEDURE: Endobronchial Ultrasound Guided Transthoracic Needle Biopsy Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: A) Age 18 years or older B) Patients with confirmed or suspected non-small cell lung cancer who require a mediastinoscopy as part of their staging investigations of the mediastinum to determine suitability for lung cancer resection will be considered for the trial. C) Patients with undiagnosed enlarged lymph nodes in the mediastinum suspicious for lung cancer in which a tissue diagnosis is required. Exclusion Criteria: A) Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy or a mediastinoscopy or who are not suitable for definitive surgical resection by thoracotomy will be excluded. B) Patients who have verified stage IV disease or who are not appropriate for lung cancer resection by virtue of direct invasion of mediastinal structures or large parts of the chest wall. C) Known small cell lung cancer. D) Patients where there is a high clinical suspicion of lymphoma. E) Inability to give informed consent.

Study Objectives This is a phase II, multi-center study of pomalidomide in adult patients with PMF, SMF, and unclassifiable MPN showing at least grade 1 bone marrow fibrosis and requiring therapy. All patients will receive per oral pomalidomide on a daily basis. First cohort (Before Amendment No. 1 ID 1-41): Treatment starts with a phase of pomalidomide therapy with 2 mg per day. Individual dose reduction as outlined in the safety section is allowed. If no response was achieved (no complete remission (CR), partial response (PR), clinical improvement (CI) and no progressive disease according to the IWG-MRT criteria) after 3 months, prednisolone is added in a starting dose of 30 mg per day. In the absence of progressive disease, at least 6 months of treatment with pomalidomide is intended. In patients without disease progression after 6 months and those with response to treatment are intended to receive pomalidomide for at least 12 months. Additional antiproliferative treatment with hydroxyurea for leukocytosis (\>20 x 109/l) and/or thrombocytosis (\>750 x 109/l) and/or symptomatic splenomegaly in a starting dose of 2g/day with individual dose adjustment is allowed. Second cohort (After Amendment No. 1 ID \> 41): To evaluate the relative impact of prednisolone to the objective response rate, a randomization has been integrated into the study concept. The addition of prednisolone is up-front randomized for the start of prednisolone either after 3 or 6 cycles of treatment with pomalidomide as single agent if no response occurred during this period. This results in the following treatment arms: Treatment Arm A) Pomalidomide 0.5 mg per day + additional prednisolone at start of cycle 4 (day 85), in case no response was achieved until end of cycle 3. Treatment Arm B) Pomalidomide 0.5 mg per day + additional prednisolone at start of cycle 7 (day 169), if no response was achieved until end of cycle 6. Treatment for all patients starts with pomalidomide as single agent at a dose of 0.5mg per day. The addition of prednisolone will be initiated as randomized either at start of cycle 4 or start of cycle 7 (starting dose 30 mg per day). In the absence of progressive disease, at least 12 cycles of treatment with pomalidomide are intended. Additional antiproliferative treatment with hydroxyurea for leukocytosis (\>20 x 109/l) and/or thrombocytosis (\>750 x 109/l) and/or symptomatic splenomegaly in a starting dose of 2g/day with individual dose adjustment is allowed. Conditions: Myeloproliferative Neoplasms Intervention / Treatment: DRUG: Pomalidomide Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: Both female and male patients meeting the mentioned inclusion and exclusion criteria will be included in this clinical trial. The risk to get PMF or SMF does not depend on a patient's gender. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Age ≥50 years at the time of voluntarily signing an IRB/IEC-approved informed consent 2. Diagnosis of Myeloproliferative Neoplasms (MPN) either de novo myelofibrosis according to WHO criteria (PMF) \[20\], secondary myelofibrosis (post-PV MF and post-ET MF according to the IWG-MRT consensus terminology) \[21\] or unclassifiable MPN with biopsy proven myelofibrosis 3. Anemia with hemoglobin level of \<10 g/dl or transfusion-dependent anemia and/or thrombocytopenia \<50 /nl or transfusion-dependent thrombocytopenia and/or neutropenia \<1.0 /nl 4. Splenomegaly (\>11 cm diameter) and/or leukoerythroblastosis 5. Adequate organ function, i.e. ALT and/or AST \<3 x upper limit of normal (ULN), total bilirubin \<3 x ULN, and serum creatinine \<2 mg/dl 6. Subject must be willing to receive transfusion of blood products 7. ECOG performance status \< 3 8. Female subjects with non-childbearing potential: * Agree to have a pregnancy test at baseline 9. Male subjects: * Agree to use condoms throughout study drug therapy, during any dose interruption and for four weeks after cessation of study therapy if their partner is of childbearing potential and has no contraception. * Agree not to donate semen during study drug therapy and for four weeks after end of study drug therapy. 10. All Subjects: * Will be counseled about potential teratogenic risks of the study medication. * Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy. * Agree not to share study medication with another person and to return all unused study drug to the investigator * No more than a 12-weeks-supply of study drug will be dispensed at a time. Exclusion Criteria: The presence of any of the following will exclude a patient from study enrollment: 1. Females of childbearing potentials°, pregnant or breast feeding females 2. BCR/ABL-positivity 3. Diagnosis of ET (according to WHO 2008 criteria) 4. Diagnosis of PV (according to WHO 2008 criteria) 5. \>20% blasts in peripheral blood or bone marrow 6. Known positive status for HIV, HBV or HCV 7. Prior treatment with IMiDs (thalidomide, lenalidomide) or with Interferon-alpha within a 3 month time period before screening 8. History of thrombosis or pulmonary embolism 9. Peripheral neuropathy \>grade 1 CTC 10. No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation. 11. Presence of any medical/psychiatric condition or laboratory abnormalities which may limit full compliance with the study, increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study 12. Drug or alcohol abuse within the last 6 months 13. Patients with a "currently active" second malignancy other than nonmelanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year. Criteria for women of non-childbearing potential: A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria: * Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year. Amenorrhoea following cancer therapy does not rule out childbearing potential * Premature ovarian failure confirmed by a specialist gynecologist * Previous bilateral salpingo-oophorectomy, or hysterectomy * XY genotype, Turner syndrome, uterine agenesis

Study Objectives Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed electric fields (nsPEF) Conditions: Basal Cell Carcinomas Intervention / Treatment: DEVICE: PulseCure pulse generator and Derm-pulse electrode 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: 1. Study subjects must have had diagnosed at least one BCCon their trunk 2. The subject is from 18-75 years of age, inclusive. 3. The subject must sign and date all informed consent statements. Exclusion Criteria: 1. The subject is exhibiting signs of a bacterial or viral infection, including fever. 2. The subject is unwilling to allow a biopsy of a malignant lesion for histological analysis. 3. The subject has a pace maker or other electronic device implanted

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. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and gemcitabine in treating patients who have advanced cancer. Conditions: Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: gemcitabine hydrochloride, DRUG: oxaliplatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: Histologically proven metastatic or unresectable malignancy for which standard therapy does not exist or is no longer effective No greater than 3 prior treatment regimens No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No clinically significant neuropathy Not pregnant or nursing Fertile patients must use effective contraception No allergy to platinum compounds or antiemetics No uncontrolled active infection or other illness PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics No prior radiotherapy to at least 30% of bone marrow At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agents No other concurrent anticancer therapy No HIV positive patients receiving antiretroviral therapy (HAART)

Study Objectives Primary Objective: * To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients Secondary Objectives: * To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals * To assess the clinical safety of cabazitaxel * To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during infusion and up to 5h post end of infusion) Conditions: Neoplasms, Malignant Intervention / Treatment: DRUG: Cabazitaxel (XRP6258) Location: Netherlands, Belgium, United States, Denmark, Sweden 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 malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, and a treatment with a novel taxane agent is considered. Exclusion criteria: * Conditions with screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pace-maker, atrial fibrillation or flutter * QTcF \>480 msec on screening Electrocardiogram (ECG) * Significant hypokalemia at screening (serum potassium \<3.5 mMol/L) * Significant hypomagnesemia at screening (serum magnesium \<0.7 mMol/L) (Note: Patient may be enrolled after correction of these laboratory abnormalities) * Patient receives (and cannot discontinue), or is scheduled to receive a QT-prolonging drug The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Objectives The present randomized, open, multicentric Phase II trial, in parallel groups with two arms of treatment, compares the treatment A, moderate hypofractionated radiotherapy of 62Gy, to treatment B, stereotactic irradiation of 37.5 Gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. The study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62Gy in 20 fractions of 3.1Gy) and by a stereotactic radiotherapy (37.5Gy in 5 fractions of 7.5Gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate. Ninety-six patients and 9 centers are included in the protocol. Conditions: Prostatic Adenocarcinoma Intervention / Treatment: RADIATION: Moderate hypofractionated radiotherapy, RADIATION: Stereotactic radiotherapy Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * age superior or equal to 18 years and inferior to 80 years. * patient with a low- to intermediate-risk prostate cancer, according to D'Amico classification, for an exclusive irradiation. * prostate cancer histologically proven. * performance index OMS (World Health Organization) of grade 0-2. * indication of external beam radiotherapy validate by the medical commission of the institution. * IPSS (International Prostate Symptom Score \< 15/35 (without alpha-blocker). * the signed consent form. Exclusion Criteria: * Rectal surgery antecedents. * prostate resection less than 6 mois. * Involvement of the seminal vesicles or of the capsule on MRI. * patient who can't cooperate during the treatment. * pelvic irradiation antecedents. * antecedents of inflammatory intestinal pathologies. * neoplasia. * patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect). * patients receiving anticoagulant treatment. * other undergoing study that may interfere with the present study. * patient under legal protection measure. * hypersensitivity to hyaluronic acid. * patient with auto-immune disease. * patient receiving immunosuppressive medication. * severe allergies. * history of endocarditis.

Study Objectives RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of VNP40101M in treating young patients with recurrent, progressive, or refractory primary brain tumors. Conditions: Brain and Central Nervous System Tumors Intervention / Treatment: DRUG: laromustine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: * Histologically confirmed\* primary brain tumor, including benign brain tumors (e.g., low-grade glioma) * Recurrent or progressive disease OR refractory to standard therapy NOTE: \*Patients with intrinsic brain stem or diffuse optic pathway tumors do not require histological confirmation, but must have clinical and/or radiographic evidence of disease progression * No bone marrow disease PATIENT CHARACTERISTICS: Age * 21 and under Performance status * Karnofsky 50-100% (for patients \> 16 years of age) OR * Lansky 50-100% (for patients ≤ 16 years of age) Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3\* * Platelet count ≥ 100,000/mm\^3\* * Hemoglobin ≥ 8 g/dL\* NOTE: \*Unsupported Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT and AST ≤ 2.5 times ULN * No overt hepatic disease Renal * BUN \< 25 mg/dL * Creatinine ≤ 1.5 times ULN for age OR * Glomerular filtration rate \> 70 mL/min * No overt renal disease Cardiovascular * Shortening fraction ≥ 30% by echocardiogram OR * Ejection fraction ≥ 50% by gated radionucleotide study * No clinically significant cardiac arrhythmia by EKG * No overt cardiac disease Pulmonary * DLCO ≥ 60% of predicted * Chest X-ray normal (defined as absence of pulmonary infiltrates, pneumonitis, pleural effusion, pulmonary hemorrhage, or fibrosis) AND a resting pulse oximetry reading of \> 94% in room air (for patients who cannot perform the DLCO) * No overt pulmonary disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Neurologic deficits allowed provided there has been no deficit progression for ≥ 1 week before study entry * No uncontrolled infection * No known hypersensitivity to polyethylene glycol PRIOR CONCURRENT THERAPY: Biologic therapy * At least 6 months since prior allogeneic bone marrow or stem cell transplantation * At least 3 months since prior autologous bone marrow or stem cell transplantation * More than 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa) * At least 3 weeks since prior myelosuppressive anticancer biologic therapy * No concurrent routine colony-stimulating factors Chemotherapy * At least 3 weeks since prior myelosuppressive anticancer chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy * Concurrent corticosteroids allowed provided dose is stable or decreasing for ≥ 1 week before study entry Radiotherapy * At least 3 months since prior craniospinal irradiation ≥ 18 Gy * At least 2 weeks since prior focal irradiation to the primary tumor and/or symptomatic metastatic sites Surgery * Not specified Other * At least 7 days since prior nonmyelosuppressive anticancer therapy * At least 7 days since prior investigational agents * Concurrent enzyme-inducing anticonvulsant drugs allowed * No other concurrent anticancer or experimental agents or therapies

Study Objectives This study will examine the effectiveness of a targeted, health literate educational intervention for people of color compared to a standard melanoma education pamphlet for increasing knowledge and promoting early melanoma detection. It is hypothesized that people of color are less aware of their risk for developing melanoma and that a targeted educational intervention will help increase knowledge and promote early melanoma detection especially in individuals with low health literacy. Conditions: Melanoma Intervention / Treatment: BEHAVIORAL: ABCDEs of Melanoma Skin Cancer, BEHAVIORAL: ABCDEs of Melanoma Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * English-speaking * Self-identifies with one of the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic Exclusion Criteria: * Not proficient in English * Unable to give informed consent * Does not self-identify with the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic

Study Objectives RATIONALE: Vaccines made from mouse DNA may help the body build an effective immune response to kill cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of mouse DNA vaccine in treating patients with recurrent B-cell lymphoma. Conditions: Lymphoma Intervention / Treatment: BIOLOGICAL: plasmid DNA vaccine therapy, OTHER: flow cytometry, OTHER: immunoenzyme technique Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have a functional immune system as determined by the following tests: * Serum proteins immunoelectrophoresis (serum IgG levels ≥ 0.5 g/dL are required) * No evidence of anergy as shown by positive skin test with tetanus toxoid, mumps or Candida. OR * Circulating T-cells as measured by flow cytometry (serum CD4+ and CD8+ T-cell counts ≥ 250 and 150 cells/μL, respectively) Patients must have histologically proven (and confirmed at MSKCC) B-cell lymphoma of any histology, excluding Burkitt's lymphoma, Lymphoblastic lymphoma (due to their aggressiveness and low likelihood of response to immune therapy). * CD20 surface expression must be confirmed by immunohistochemical staining or flow. * Measurable disease is not a pre-requisite for enrollment in the study. However, if a patient does have measurable disease as evidenced by imaging studies, these have to be done within eight weeks of starting treatment. * Patients must have a Karnofsky performance status ≥ 70%. * Patients with evidence of active disease, progression of disease or relapsed disease following one or more prior regimens of chemotherapy, immunotherapy or radiation therapy (including autologous stem cell transplants), not requiring immediate cytoreductive chemotherapy. All treatment must be completed at least four weeks prior to administration of the first vaccination, except immunotherapy and radioimmunotherapy, which must be completed at least 90 days prior to receiving the first vaccination. Active disease includes patients with minor or partial responses after therapy as evidenced by FDG-avid disease or biopsy. * Age ≥ 18. * Adequate contraception during study enrollment. * Avoidance of breast-feeding their infants during the study enrollment. * Patients must have adequate organ and marrow function as defined below: * Absolute Neutrophil Count ≥ 1,000/uL * Platelets ≥ 75,000/uL * Total bilirubin ≤ 2.5 times institutional upper limit * AST/ALT ≤ 2.5 times institutional upper limit * Creatinine ≤ 2 mg/dL * PT/PTT ≤ 1.5 times institutional upper limit * Patients must have no signs of congestive heart failure according to the New York Heart Failure Guidelines Class III/IV. Exclusion Criteria: * Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study. * Patients who have undergone an allogeneic stem cell transplant at any time. * Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Patients who have received immunotherapy (i.e. rituximab) or radioimmuno therapy (i.e. tositumomab or ibritumomab) within the past 90 days. Patients who display signs of anergy as indicated by skin testing. * Patients with Burkitt's lymphoma and Lymphoblastic Lymphoma. * Patients who have been previously immunized with any type of DNA vaccine. * Patients who have positive anti-DS-DNA antibodies. * Patients with life expectancy less than 3 months from the time of enrollment. * Patients with serious underlying medical conditions, active infections requiring the use of antimicrobial drugs or active bleeding. * Patients with active Hepatitis C (HC) or Hepatitis B (HB) infection, the latter defined as a positive test for HBsAg or measurable viral load. In patients who are HBsAg negative but HBsAg positive (regardless of HBsAb status), a HB viral load will be performed and if positive the subject will be excluded. If the subject is HBsAg negative, HBcAb positive (regardless of HBsAb status) but with negative HBV viral load, the subject may be included but must undergo HBV DNA PCR testing at least every two months from the start of treatment during the routine study visits for as long as the subject remains on study. Prophylactic antiviral therapy, in addition to the monitoring described above, may be initiated at the discretion of the investigator. Patients with documented HIV infection or other immunodeficiency disorder or on chronic steroids treatment. * Patients with autoimmune diseases such as but not limited to rheumatoid arthritis, Sjogren disease, ulcerative colitis, autoimmune hepatitis. * Pregnant or nursing women. Women of child-bearing age will be tested for qualitative β-HCG within 2 weeks of immunization. * Patients receiving other investigational drug.

Study Objectives RATIONALE: Drugs used in chemotherapy, such as pentostatin, cyclophosphamide, and CAMPATH-1H work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well pentostatin, cyclophosphamide, rituximab, and CAMPATH-1H work in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia. Conditions: Leukemia Intervention / Treatment: BIOLOGICAL: rituximab, DRUG: cyclophosphamide, DRUG: pentostatin, DRUG: Alemtuzumab 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: * Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria: * Peripheral blood absolute lymphocyte count greater than 5,000/mm\^3 * Lymphocytosis must comprise small to moderate size lymphocytes with no greater than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically * Phenotypically characterized CLL defined by the following: * Predominant population of cells share B-cell antigens with CD5 in the absence of other pan-T-cell markers (CD3 or CD2) * B cell expresses either kappa or lambda light chains * Surface immunoglobulin with low cell surface density expression * Requires chemotherapy, as indicated by any of the following: * Disease-related symptoms * Weight loss of 10% or more within the past 6 months * Extreme fatigue * Fevers greater than 100.5°F for 2 weeks without evidence of infection * Night sweats without evidence of infection * Evidence of progressive marrow failure manifested by the development of or worsening anemia (hemoglobin no greater than 10 g/dL) and/or thrombocytopenia (platelet count no greater than 100,000/mm\^3) * Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly * Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy * Progressive lymphocytosis with an increase of greater than 50% over a 2-month period OR an anticipated doubling time of less than 6 months * Demonstrated progression after at least 1 course of either an alkylating agent-based or purine nucleoside-based (e.g., fludarabine) regimen OR failed to achieve a meaningful response OR relapsed after prior therapy * Patients who have relapsed after a pentostatin-based regimen are eligible provided the response was greater than 12 months prior to study entry * 18 and over * ECOG Performance Status 0-2 * Bilirubin no greater than 2 mg/dL (unless secondary to tumor, hemolysis, or Gilbert syndrome) * Creatinine no greater than 2.0 mg/dL * Creatinine clearance ≥ 30 mL/min * Negative pregnancy test * Fertile patients must use 2 methods of effective contraception (including 1 barrier method) for at least 28 days before starting lenalidomide, while participating in the study, and for at least 28 days after discontinuation/stopping lenalidomide * At least 8 weeks since prior rituximab * At least 6 weeks since prior chemotherapy * At least 1 year since prior pentostatin, cyclophosphamide, and rituximab (PCR) therapy * PCR therapy at least 1 year prior to study entry allowed Exclusion criteria: * Bone marrow dysplasia related to prior therapy * New York Heart Association class III or IV heart failure * Prior lenalidomide * Other malignancy within the past 2 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix * Pregnant or nursing * Concurrent oral or IV antibiotics for active infection

Study Objectives The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism \[VTE\] in cancer patients at high risk for VTE and who were undergoing chemotherapy. The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population. Conditions: Venous Thromboembolism, Cancer Intervention / Treatment: DRUG: Semuloparin sodium, DRUG: Placebo (for semuloparin) Location: Argentina, Taiwan, Korea, Republic of, Malaysia, Estonia, South Africa, Lithuania, Portugal, Sweden, Colombia, Slovenia, India, Slovakia, Austria, Norway, Greece, Israel, Belarus, Australia, Romania, Spain, France, Latvia, Switzerland, Mexico, Chile, Hong Kong, Netherlands, Hungary, Germany, United States, Croatia, China, Canada, United Kingdom, Czech Republic, Russian Federation, Italy, Finland, Peru, Poland, Indonesia, Serbia, Ukraine, Belgium, Brazil, Denmark, Bulgaria, Ireland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: Cancer patient with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary initiating a (new) course of chemotherapy with a minimum intent of 3 months therapy Exclusion Criteria: * Required systematic venous thromboprophylaxis or curative treatment with anti-coagulant or thrombolytic; * High risk of bleeding; * Severe renal impairment (estimated creatinine clearance \<30 mL/min); * ECOG (Eastern Cooperative Oncology Group) performance status 3 \& 4; * Major surgery within 4 weeks before randomization; * Known hypersensitivity to unfractionated heparin \[UFH\] or low molecular weight heparin \[LMWH\]. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Study Objectives Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC) Part 2: To compare median duration of progression free survival (PFS) Conditions: Metastatic Colorectal Cancer (MCRC) Intervention / Treatment: DRUG: Cetuximab, DRUG: Irinotecan, DRUG: Brivanib, DRUG: Brivanib, DRUG: Brivanib Placebo Location: Argentina, Korea, Republic of, United States, Spain, Denmark, Sweden, Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Biopsy proven MCRC * Prior irinotecan allowed * Prior Erbitux allowed Exclusion Criteria: * No prior brivanib * No prior combination of irinotecan with Erbitux * No secondary malignancies * No anti-coagulation therapy * No prior history of blood clots requiring anti-coagulation

Study Objectives The intra-/perilesional application of interleukin-2 seems to be a safe and effective treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of intransit metastases the overall survival rate is still 20-30%. However, the management of intransit metastases is sometimes difficult because of frequent recurrences. IL-2 intralesionally seems to be an non-invasive option as pilot studies indicate. In this study the safety and efficacy of IL-2 are evaluated. Conditions: Melanoma Intervention / Treatment: DRUG: Interleukin-2 (Proleukin) Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age 18+ * Informed consent * Histologically proven melanoma * Have confirmed stage IIIB or stage IV disease (AJCC 2002) with skin or soft-tissue metastases Exclusion Criteria: * Pregnant or lactating women * Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina) * Patients with severe liver disease or severe renal disease * Simultaneous immunosuppressive treatment (e.g. steroids) * Simultaneous chemotherapy * Pretreated soft-tissue or skin metastases (e.g. cryo-, radiotherapy)

Study Objectives The purpose of this study is to investigate the effects of axitinib, a potent angiogenesis inhibitor, on tissue and clinical outcome in combination with chemotherapy given to patients with mesothelioma Conditions: Malignant Pleural Mesothelioma Intervention / Treatment: BIOLOGICAL: axitinib, DRUG: chemotherapy Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * histologically or cytologically diagnosed malignant mesothelioma * age \> 18 years * Medically suitable for limited surgical intervention (pleural biopsies or limited pleurectomy) * Measurable or evaluable disease is not required * Ability to understand the study and give signed informed consent including the approval to accept a second thoracoscopic or surgical treatment after the third course * No previous chemotherapy * Radiotherapy is allowed when this is given for palliation, the interval is \> 4 weeks, not more than 1/3 of the bone marrow capacity or all tumor is within the irradiation field. * WHO performance status =\< 2 * Adequate organ function as evidenced by the following peripheral blood counts or serum chemistries at study entry: Hematology: * ANC=\>1.5 x 109/L, * Platelets=\>150 x 109/L, * Hemoglobin =\> 6,0 mmol/l Chemistry: * total serum bilirubin \< UNL; * AST and ALT= \< 2.5xUNL, * AP \< 5xUNL (unless bone metastases are present in the absence or any liver disease) * Serum creatinine =\< 2xUNL Exclusion Criteria: * Active uncontrolled infection, severe cardiac dysfunction or uncorrectable bleeding tendency * Previous successful pleurodesis * Uncontrolled hypertension * Symptomatic peripheral neuropathy =\> grade 2 according to NCIC CTC,version 3.0 * Presence of symptomatic CNS metastases * Unstable peptic ulcer, unstable diabetes mellitus or other serious disabling condition * Concomitant administration to any other experimental drugs under investigation * Impaired renal function

Study Objectives This research study is designed to determine the safety and dosage of special cells that may make a patients own immune system fight the cancer. To do this we will put two special genes into cancer cells taken from the patients body. The genes we put in make the cancer cells produce lymphotactin, a natural substance that attracts immune system cells to the cancer, and IL-2 a natural substance that may help the immune system kill cancer cells. Some of these cells will then be put back in the patient's body. Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that substances like lymphotactin and IL-2 help the body kill cancer cells. A treatment similar to this has been used in ten children previously and similar treatments are being used in adults with other cancers. The purpose of this study is to learn the side effects and safe 'dosage' of these special cells. Conditions: Neuroblastoma Intervention / Treatment: PROCEDURE: Skin Biopsy, GENETIC: Gene Modified Neuroblastoma Cells Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

* All patients under 21 years of age at diagnosis with recurrent, advanced stage neuroblastoma. * Patients must have a life expectancy of at least 8 weeks. * Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study, and have an absolute lymphocyte and neutrophil count of \>500/mm3 each. * Patients must not be currently receiving any investigational agents or have not received any tumor vaccines within the previous six weeks. * Patients must not be HIV-positive. * Patients must have bilirubin \<1.5 mg%. * Patients must have creatinine \<1.5 mg/dl. * Patients must have ECOG performance status of 0-2. * Patients must have autologous transduced neuroblastoma cells available that are demonstrably producing \>150 pg IL-2/106 cells/24 hr and are secreting Lptn. * Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form. * Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom.

Study Objectives The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia. Conditions: Non-myeloid Malignancies, Chemotherapy Induced Anaemia Intervention / Treatment: DRUG: iron isomaltoside 1000, DRUG: iron sulphate Location: India Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: 1. Men and women, aged more than 18 years. 2. Subjects diagnosed with cancer (non-myeloid malignancies) receiving chemotherapy at least 1 day prior to screening and who are going to receive at least two more chemotherapy cycles. 3. Hb \< 12 g/dL (7.4 mmol/L). 4. TfS \<50%. 5. Serum Ferritin \<800 ng/ml. 6. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 7. Willingness to participate after informed consent (including HIPAA, if applicable). Exclusion Criteria: 1. Anemia caused primarily by other factors than CIA. 2. IV or oral iron treatment within 4 weeks prior to screening visit. 3. Erythropoietin treatment within 4 weeks prior to screening visit. 4. Blood transfusion within 4 weeks prior to screening visit. 5. Imminent expectation of blood transfusion on part of treating physician. 6. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis). 7. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulfate). 8. Known hypersensitivity to any excipients in the investigational drug products. 9. Subjects with a history of multiple allergies. 10. Decompensated liver cirrhosis or active hepatitis (alanine aminotransferase (ALAT) \> 3 times upper normal limit). 11. Active acute or chronic infections (assessed by clinical judgement and if deemed necessary by investigator supplied with white blood cells (WBC) and C-reactive protein (CRP)). 12. Rheumatoid arthritis with symptoms or signs of active joint inflammation. 13. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches). 14. Planned elective surgery during the study. 15. Participation in any other clinical study (except chemotherapy protocol) within 3 months prior to screening. 16. Known intolerance to oral iron treatment. 17. Untreated B12 or folate deficiency. 18. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.

Study Objectives This prospective, randomized clinical trial double blinded study, has been carried on 160 infertile patients seeking pregnancy in Gynecology and Obstetrics Department, Zagazig University Hospitals during the period from January 2019 to November 2019, the participants' randomizations were done and patients divided into two groups; group I: included 80 women receiving Clomiphene citrate (CC) plus Isoflavonoids. Group 2: included 80 women receiving Clomiphene citrate only Conditions: Ovulation Induction, Polycystic Ovary Syndrome Intervention / Treatment: DRUG: Rosafem (FEMININE FORMULA) Location: Egypt Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: • Patient aged 18- 35 years old with primary or secondary infertility Exclusion Criteria: * Patient aged 18- 35 years old with primary or secondary infertility * Patient whose husband has a male factor of infertility. * Hepatic, renal, diabetic, thyroid or cardiovascular disorders. * Organic pelvic disease (uterine fibroids or ovarian cysts). * Abnormality detected by HSG as blocked tubes

Study Objectives This research study is being done to carefully evaluate the effect of giving radiation therapy after temporary breast reconstruction. The investigators want to see if this type of reconstruction combined with radiation will look better (once the final reconstruction has been completed) and will reduce the risk that the participant will develop complications that sometimes occur with other kinds of reconstruction procedures. The investigators also want to know if it is easier to give the radiation with this type of reconstruction than with other kinds of reconstruction procedures. The reconstruction procedure involves the temporary use of a tissue expander and an acellular dermal matrix (ADM). Conditions: Breast Cancer Intervention / Treatment: RADIATION: post-mastectomy radiation therapy (PMRT), DEVICE: tissue expander (TE), DEVICE: acellular dermal matrix (ADM) 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 must have newly diagnosed, clinical Stage I-III breast cancer with T1-T3 invasive tumors recently treated with mastectomy * Patients must have had immediate reconstruction with a TE and ADM * Participants must be candidates for postmastectomy radiation therapy (RT). Postmastectomy RT routinely is indicated for patients with pathologically-staged T3N1 (or higher stage) tumors, T1-T2 tumors with 4 or more positive nodes, some T1-T2 tumors with 1-3 positive nodes, and, infrequently, for some N0 tumors * Axillary nodes may be positive or negative * Microscopically positive margins are permitted * Systemic therapy as recommended by a medical oncologist, pre-or post-mastectomy, is permitted * Patients must agree to return for scheduled follow-up visits with their radiation oncologist 6, 12, 18 and 24 months after RT (+/- 1 month) * 18 years of age or older Exclusion Criteria: * Participants with T4 tumors * Participants with recurrent breast cancer or a history of prior breast RT * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study * Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin * HIV-positive individuals on combination antiretroviral therapy

Study Objectives The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years. In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses. The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: Pomalidomide, DRUG: Dexamethasone Location: Turkey, Estonia, Portugal, Sweden, Slovakia, Austria, Norway, Greece, Spain, France, Switzerland, Netherlands, Germany, United Kingdom, Poland, Italy, Finland, Belgium, Denmark, Ireland Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients ≥18 years old, who must understand and voluntarily sign an Informed Consent. * Patients must have documented diagnosis of Multiple Myeloma and have measurable disease. * Patients must have undergone prior treatment with ≥ 2 treatments lines, of anti-myeloma therapy. * Patients must have either refractory or relapsed and refractory disease. * Patients must have received at least 2 consecutive cycles of prior treatment that include lenalidomide and bortezomib, either alone or in combination regimens. * Patients must have received adequate alkylator therapy Exclusion Criteria: * Prior history of malignancies, other than Multiple Myeloma. * Previous therapy with Pomalidomide, hypersensitivity to thalidomide and lenalidomide or dexamethasone. * Patients who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant. * Patients who are planning for or who are eligible for stem cell transplant. * Patients who received major surgery and any anti-myeloma drug therapy within the last 14 days of starting study treatment. * Patients with a current disease that can interfere with protocol procedures or study treatment. * Patients unable or unwilling to undergo antithrombotic prophylactic treatment. * Pregnant or breastfeeding females.

Study Objectives The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Systemic adverse events will also be evaluated. A secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation. Conditions: Choroidal Melanoma Intervention / Treatment: DRUG: ranibizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Patients with newly diagnosed choroidal melanoma undergoing proton therapy * Tumors \>15 mm in largest diameter and/or \>5 mm in height * Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula, with best-corrected visual acuity 20/100 or better in study eye Exclusion Criteria: * History of prior treatment for choroidal melanoma * Pregnancy or lactation * Presence of diabetic retinopathy * History of retinal vascular occlusion or other retinal vascular disease * Active ocular inflammation or history of uveitis in either eye * History of uncontrolled glaucoma (defined as intraocular pressure \>30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye * Previous intravitreal injections of Avastin® in the study eye or in the non-study eye within 30 days. * Concurrent use of systemic anti-VEGF therapy

Study Objectives In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety. Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery. Conditions: Radiofrequency Resection Intervention / Treatment: PROCEDURE: transoral radiofrequency Resection in Oropharyngeal Tumor Surgery Location: Germany Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: - 18 years and older benign or malign tumor of the oropharynx tumor must be resectable transorally Exclusion Criteria: * Prior radiotherapy or chemotherapy

Study Objectives The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib. Conditions: Metastatic Solid Tumor Intervention / Treatment: DRUG: Topotecan, DRUG: Erlotinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have a histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. * Prior chemotherapy must have been completed at least 3 weeks prior to enrollment (6 weeks for nitrosureas and mitomycin) and the patient must have recovered from all associated toxicities (except alopecia and neuropathy grade 1 according to the NCI-CTC, version 3.0 classification). Radiation must have been completed 8 weeks prior to enrollment. Major surgery must have been completed 4 weeks prior to enrollment. Hormonal therapy must have been completed at least 2 weeks prior. * Age \>18 years. * ECOG performance status \<1 (Karnofsky \>70%) * Life expectancy of greater than 12 weeks. * Patients must have normal organ and marrow function as defined below: White blood cell count \>2,500/mm3, Absolute neutrophil count (ANC) \>1,500/ mm3, Platelet count \>100,000/ mm3, Hemoglobin \> 10 g/dL, Albumin \>2.5 g/dL, Total bilirubin \<1.5 X institutional upper limit of normal (ULN), AST/ALT \<1.5 X institutional ULN, Serum creatinine \<2.0 g/dL, Creatinine clearance \>40 mL/min * Patients must be able to swallow and retain oral medication * Female patients must be nonpregnant and nonlactating. All patients of childbearing potential must implement an effective method of contraception during the study. All female patients (except those who are postmenopausal or surgically sterilized) must have a negative pre-study serum or urine pregnancy test obtained within 7 days of study enrollment. * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: * Patients may not be receiving any other investigational agents. Participation in other clinical trials with any investigational drugs must have been completed ≥ 28 days prior to enrollment on this trial (or longer based on the halflife of the investigational agent). * Patients must have no more than 3 prior lines of therapy. The patient may have only received carboplatin and/or gemcitabine in one of the prior lines of therapy. * Patients must not be receiving concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy for cancer). Low dose maintenance steroids are acceptable if the patient will remain on a stable dose during cycles 1, 2 and 3 (to ensure continuity for topotecan pharmacokinetic studies). * Patient may not have a history of serious allergic reactions attributed to compounds of similar chemical composition to topotecan (camptothecins) and/or erlotinib (tyrosine kinase inhibitors). * Patients must not have malabsorption syndrome, any disease significantly altering gastrointestinal function, or resection of the stomach or small bowel. * Patients must not be taking warfarin (including low dose anticoagulants). * Patients must not be taking concurrent treatment with potent inhibitors of cytochrome P450 3A4. For patients who were receiving treatment with such agents, a one-week washout period is required prior to beginning the protocol. * Patients must not be taking concurrent treatment with potent inducers of cytochrome P450 3A4, such as phenytoin, carbamazepine, rifampin, barbiturates, or St. John's Wort. For patients who were receiving treatment with such agents, a one week washout period is required prior to beginning the protocol. * Patients must have no active serious infection, fever \> 38.2 degrees Celsius, or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment (i.e., documented HIV infection, uncontrolled hypertension, uncontrolled CNS metastases, unstable angina, congestive heart failure, poorly controlled diabetes, coronary angioplasty within 6 months, myocardial infarction within 6 months, uncontrolled atrial or ventricular arrhythmias). * Patients should not have psychological, familial, sociological geographical conditions that do not permit medical follow-up and compliance with the study protocol.

Study Objectives The purpose of this study is to determine whether the use of hybrid simulation of the breast are more effective in teaching CBE technique and culturally sensitive doctor-patient communication skills to medical students than the traditional method. Conditions: Medical Education, Clinical Breast Examination, Medical Simulation, Standardized Patient Intervention / Treatment: BEHAVIORAL: Teaching using Hybrid Simulation of breast examination, BEHAVIORAL: Teaching using traditional method Location: Lebanon Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Third year medical students (Med III) at the American University of Beirut * Rotating in the Obstetrics and Gynecology department at the American University of Beirut Medical Center Exclusion Criteria: * None

Study Objectives The purpose of this phase II clinical study is to test the good and bad effects of T-VEC (talimogene laherparepvec) with or without hypofractionated radiotherapy on people with melanoma, Merkel cell carcinoma, or other solid tumors with skin metastasis. Conditions: Melanoma, Merkel Cell Carcinoma, Other Solid Tumors Intervention / Treatment: DRUG: TALIMOGENE LAHERPAREPVEC (TVEC), RADIATION: Hypofractionated Radiotherapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Man or woman ≥ 18 years old * Life expectancy \> 4 months * Histopathologically confirmed melanoma, Merkel cell carcinoma or other solid tumor malignancy * Cutaneous subcutaneous soft tissue, or superficial lymphatic metastasis not suitable for surgical resection * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Cutaneous subcutaneous soft tissue, or superficial lymphatic metastasis that is amenable to injection and irradiation and \> 10 mm in longest dimension ° Cutaneous metastasis in a region of previous radiation therapy is amenable to radiation therapy as part of this protocol if at least 6 months has elapsed since prior radiotherapy and the dose of radiotherapy previously administered did not exceed an equivalent dose of 60 Gy in 2 Gy equivalent fractions at the skin surface (using linear-quadratic modeling with alpha/beta=11.5) * Metastasis that is \> 10 mm in longest dimensionor exhibits radiotracer uptake consistent with metastasis on PET/CT * Adequate coagulation function (platelet count \>50 k/mcL, international normalized ratio of \< 1.5) * Resolution or stabilization of clinically significant adverse events from prior therapy * Able to provide valid written informed consent Exclusion Criteria: * Active herpetic skin lesions or prior complications of HSV-1 infection (such as herpetic keratitis, herpetic encephalitis) * Receipt of a therapeutic anticoagulant * Receipt of live vaccine within 28 days of planned first dose of TVEC * Receipt of another cancer therapy (targeted therapy, chemotherapy, investigational therapy, immunotherapy, radiotherapy or surgery) which is yielding an overall response (by response criteria in this study) ° Patients with stable or progressing disease (as determined by at least 2 consecutive assessments at 6-week interval) can continue to receive the same therapy during treatment as part of this protocol * History of symptomatic autoimmune disease (such as lupus, scleroderma, Crohn's disease, ulcerative colitis) requiring systemic treatment (for example corticosteroids or immunosuppressants); replacement therapy (for example, thyroxine, insulin) is not considered a systemic treatment * History of high grade (CTCAE ≥ Grade 3) immune mediated adverse event from prior cancer immunotherapy * History of CTCAE ≥ Grade 2 immune mediated endocrinopathy from prior cancer immunotherapy * Intermittent or chronic use of oral or intravenous antiherpetic drug (such as acyclovir) * Active or chronic hepatitis B or C infection ° Previously infected, with evidence of immunity and no evidence of active hepatitis is not an exclusion criterion * Known human immunodeficiency virus (HIV) infection * Known leukemia or lymphoma * Common variable immunodeficiency * Patients requiring chronic high dose immunosuppressants including steroids (prednisone daily equivalent of ≥ 10 mg) * Known severe congenital or acquired cellular or humoral immunodeficient or immunocompromised patients * High likelihood of protocol non-compliance (in opinion of investigator) * Woman of childbearing potential unwilling to use effective contraception during protocol treatment and for 3 months after last dose of Talimogene Laherparepvec * Woman of childbearing potential that is pregnant or breast-feeding, or planning to become pregnant or breast-feed during protocol treatment and for 3 months after last dose of Talimogene Laherparepvec

Study Objectives For patients with Prostate Cancer advances in medical technology have enabled us to identify "accessory" (additional) pudendal arteries (called APA) while performing a laparoscopic radical prostatectomy (a scope with a video camera is used during the surgery). APAs running near the prostate gland are identified in approximately 1 in 3 to 4 patients. However, large APAs, like the ones looked for in this study, are identified in 15-18% of all patients. These arteries are preserved more than 80% of the time, depending on their size and location.With this study, we plan to evaluate whether APAs supply blood to the penis and male erections, as well as the amount supplied. Conditions: Prostate Cancer Intervention / Treatment: PROCEDURE: Trimix Injection with Doppler Ultrasound 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: * They have selected a LRP, with or without robotic assistance, by Jonathan Colelman, MD, Bertrand Guillonneau, MD, Vincent Laudone, MD, Raul Parra, MD, or Karim Touijer MD for definitive treatment of their prostate cancer after a full discussion of treatment options. Exclusion Criteria: * Patients undergoing Open Radical Prostatectomy * Patients with prior history of insulin dependent diabetes mellitus * Patient who have received prior radiation therapy to the pelvis or prostate * Patients requiring anticoagulation postoperatively * Known allergy to Phenylephrine, Alprostadil, Papaverine or Phentolamine * Patients whose systolic blood pressure is below 90 mmHg at the time of evaluation despite routine measures taken by the anesthesiologist at his best criteria. * Patients with labile hypertension or history of prior priapism * Patients with penile scarring or penile prosthesis * Patients with an International Index of Erectile Function score \< 24

Study Objectives The study will evaluate and refine a breast screening and diagnosis device. Conditions: Breast Cancer, Mass Cystic, Benign Mass Intervention / Treatment: PROCEDURE: 3D Tomosynthesis and ultrasound imaging Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * To participate in this research study you must be a female over the age of 25 * Have had a normal mammogram or are scheduled for a breast biopsy * Have cysts or have been recommended to have a 6 month follow up mammogram after your biopsy. Exclusion Criteria: * Male * Under the age of 25 * Documented breast cancer

Study Objectives The present study is to evaluate the effect of anesthetic agents ( propofol , sevoflurane) on intracranial pressure of female patients undergoing laparoscopic-robotic surgery. Conditions: Uterus Myoma, Uterine Cancer Intervention / Treatment: DRUG: Sevoflurane, DRUG: Propofol Location: Korea, Republic of Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * female patients undergoing robot-assisted laparoscopic hysterectomy or myomectomy Exclusion Criteria: * history of brain hemorrhage or brain infarction * liver disease or end stage renal disease * glaucoma or any signs of increased intraocular pressure * combined wtih other types of operation * patient refusal * weight less than 40 kg or over 100 kg

Study Objectives Colorectal cancer (CRC) is the second leading cause of cancer deaths in the United States. About 90% of CRC related deaths are due to metastatic spread-mostly to the liver and lungs. With adequate multidisciplinary patient selection, CRC liver and lung metastasectomy significantly improves survival and offers the best chance for a cure. However, patients with limited lung or liver metastases are clinically underserved and poorly scientifically studied. The individual indication for resection and the decision making for adjuvant systemic therapies remains a challenge. More sensitive techniques to detect occult disease are needed for metastatic CRC (mCRC) patients, and perioperative analysis of circulating tumor cells (CTCs) may provide an outstanding opportunity to develop such innovative methods. We hypothesize that CTCs are enriched during CRC liver and/or lung metastasectomy, and that they can be isolated and characterized in an attempt to identify novel therapeutic targets. CTCs are believed to be causing metastasis and may provide a non-invasive alternative to organ biopsies for the detection, characterization and monitoring of solid cancers. CTC numbers have been shown to be a strong predictor of Progression Free Survival and Overall Survival for mCRC patients. The CellSearch system (Veridex LLC, Ratinas, NJ, USA) currently is the only FDA approved test for the evaluation of CTC numbers in metastatic breast, prostate and colorectal cancer. However, the rarity of CTCs in the blood leads to limited capture efficiency and the CellSearch system fixes cells, preventing further molecular characterization of CTCs by functional assays and primary cell culture. In this protocol the CellSearch system will be compared to a new technology, called the Flexible Micro Spring Array (FMSA) device, developed by Dr. Zheng, Department of Bioengineering, Penn State University, University Park. This novel approach enables size-exclusion based filtration for viable CTC enrichment. The FMSA device is inexpensive, works rapidly, and retains viable CTCs for further biological study. Using both the CellSearch system and the FMSA device, we will determine the kinetics of CTC shedding into circulation, develop an effective system for isolation, enumeration, and further enrichment CTCs, and use this system to find characteristics of different CTC populations. Conditions: Stage IV Colorectal Cancer, Liver Metastases, Lung Metastases Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Subjects older than 18 years will be included. * Subjects with colorectal primary carcinomas metastatic to the liver and/or lungs who will undergo a synchronous resection of both primary tumor and liver metastases will also be enrolled. * Subjects of all genders and ethnicities will be included. * Subjects with the diagnosis of stage IV primary CRC will be included if metastases are limited to liver and/or lungs at the time of primary surgery. * The histopathology of the CRC primary tumor must be documented to be adenocarcinoma. * Subjects with the diagnosis of syn- and metachronous liver and/or lung metastases from colorectal carcinoma will be included, as long as metastases at both sites are resectable by minimal invasive or conventional approach (usually sequentially and not simultaneously). * Liver and lung metastases must be defined according to radiological criteria. In case of doubt on radiologic findings, percutaneous biopsy will have to be obtained. * Subjects must be capable of giving informed consent or have an acceptable surrogate capable of giving legally authorized consent on the subject's behalf. Exclusion Criteria: * Subjects with the concurrent diagnosis of an active second malignancy besides basal cell carcinoma of the skin will be excluded, if there is evidence of disease burden or the patient is currently treated with chemotherapy. * Subjects with a Hemoglobin of \<8g/dl in the morning of the procedure will be excluded. * In subjects who had needed intraoperative transfusions \>4 units of RPBCs, no further blood will be drawn for CTC analysis. * Pregnant women will be excluded.

Study Objectives The aim of the study is to investigate body composition in newborn children of women with PCOS and controls and to investigate adverse obstetric outcomes in pregnant women with PCOS. Conditions: Polycystic Ovary Syndrome, PCOS Intervention / Treatment: Location: Denmark Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Diagnosed with PCOS and giving birth during 2003-2011 Exclusion Criteria: * Multiple pregnancy

Study Objectives Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours and also how well it is tolerated. Conditions: Renal Cell Carcinoma Intervention / Treatment: DRUG: Cediranib, DRUG: Cediranib Placebo Location: Netherlands, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Confirmation of metastatic or recurrent renal cell carcinoma Exclusion Criteria: * Certain types of previous anti-cancer therapy for Renal Cell Carcinoma * Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes * Patients with a history of poorly controlled high blood pressure

Study Objectives RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together with radiation therapy works in treating patients with recurrent head and neck cancer. Conditions: Head and Neck Cancer Intervention / Treatment: DRUG: cetuximab, DRUG: cisplatin, RADIATION: intensity-modulated radiation therapy, DRUG: Nab-Paclitaxel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

DISEASE CHARACTERISTICS: * Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract * Recurrent disease or second primary SCC * Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence) * Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated to ≥ 45 Gy * More than one recurrence allowed provided the first recurrence occurred \> 6 months after the completion of prior radiotherapy * Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension) * No signs of carotid exposure * No primary nasopharyngeal or salivary gland tumor * Equivocal pulmonary nodes on chest CT scan allowed provided they are \< 1 cm, cannot be safely biopsied, or are negative on PET scan * No distant metastasis PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * ANC ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed) * Bilirubin \< 1.5 mg/dL * AST or ALT \< 2 times upper limit of normal * Creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded * No active cardiac disease, including any of the following: * Unstable angina * Uncontrolled hypertension * Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty) * Uncontrolled arrhythmia * Congestive heart failure * At least 3 heart-related hospitalizations within the past year * No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year * No concurrent medical illness that would impair patient tolerance to therapy or limit survival * No other invasive malignancy within the past 2 years * No pre-existing peripheral sensory neuropathy ≥ grade 2 * No prior severe infusion reaction to a monoclonal antibody * No prisoners or individuals who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior surgery * Prior cisplatin and cetuximab allowed * At least 6 months since prior radiotherapy or chemotherapy * No prior radiotherapy \> 75 Gy * No prior chemotherapy for recurrent head and neck cancer * Prior chemotherapy as a component of the primary treatment allowed * No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer * Patients with a new primary head and neck cancer whose prior primary head and neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy are eligible provided it has been \> 6 months since treatment

Study Objectives This study is a multicenter prospective randomized controlled trial. Potential participants in this study include patients referred for Endoscopic Ultrasound-guided fine needle aspiration (EUS-FNA) of a solid pancreatic lesion at one of the participating centers. If the patient meets inclusion criteria and signs the informed consent, they will be randomized into one of the two study arms in a 1:1 ratio. Patients will either undergo EUS-FNA with or without an on-site cytopathologist present during EUS-FNA. Patients assigned to the on-site cytopathologist arm will have the cytopathologist dictate the number of fine needle aspiration (FNA) passes performed by the endosonographer. This number will be based on the adequacy of specimen and the ability to provide a preliminary diagnosis. In the other arm, in the absence of an on-site cytopathologist, the endosonographer will perform a predetermined number of 7 passes (standard of care in the absence of an on-site cytopathologist). The technique of performing EUS-FNA (needle type, use of stylet, suction) will be standardized among all endosonographers in order to rule out confounding factors. After EUS-FNA is performed all slides will be sent to the pathology department. The slides will be sent for review regardless of which arm the patient is randomized into, and they will be reviewed by experienced cytopathologists for the purpose of determining the final diagnoses. Future clinical intervention will be monitored for the purpose of reporting the impact EUS-FNA has on the patient's clinical course and determining diagnostic accuracy. Patients will be followed prospectively for at least one year, and the gold-standard for final diagnosis of pancreatic malignancy will be defined by the presence of malignant cytology or histologic evidence (if the patient undergoes surgery) or with clinical and/or imaging follow-up consistent with pancreatic cancer (death or clinical progression). A detailed account of medical equipment used during each procedure, procedure time, clinic visits/hospitalizations due to procedure related complications, and number of repeat procedures will be recorded systematically. The investigators hypothesize that an on-site cytopathologist during EUS-FNA for pancreatic masses improves diagnostic yield, accuracy, and lowers the duration, complications and the need for repeat procedures. Conditions: Pancreatic Neoplasms, Pancreatic Cancer Intervention / Treatment: PROCEDURE: EUS-guided FNA performed with on-site Cytopathologist, PROCEDURE: EUS-guided FNA performed without on-site Cytopathologist Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Patients age: greater than or equal to 18 years * Presence of a solid pancreatic mass lesion confirmed by at least a single investigational modality such as computerized axial tomography (CT) scan, magnetic resonance imaging (MRI) or Endoscopic Ultrasound (EUS) * Ability to provide written informed consent Exclusion Criteria: * Severe coagulopathy \[International Normalized Ratio (INR) \> 1.8\] or thrombocytopenia (platelet count \<50,000) * Pure cystic lesions of the pancreas * Inability to sample lesion due to the presence of intervening blood vessels * Results of EUS-FNA would not impact patient management

Study Objectives Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain and side effects after breast surgery when used in addition to general anesthesia or sedation.The investigators would like to further discern the impact of GA or PVB on the postoperative QoR, pain and satisfaction. Conditions: Postoperative Pain, Quality of Recovery, Satisfaction Intervention / Treatment: OTHER: PVB Location: Taiwan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Patient has a physical status between ASA I and III * Female * 18 - 70 years of age * Patients able to read a newspaper in Chinese. * Elective unilateral wide excision/simple mastectomy and SLNB/ALND * Patient has signed an informed consent * Without contraindication of GA or PVB * Body mass index (BMI) less than 24 kg/m2 Exclusion Criteria: * ASA \> III * inability to provide informed consent * Bleeding disorders * Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs) * Allergy to amide-type local anesthetics or NSAIDs * Infection at the thoracic paravertebral injection site * Pregnancy or breast-feeding * Severe spine or chest wall deformity * body mass index equal to or more than 24 kg/m2 * patients with major psychosis or drug and alcohol abuse * patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease * Patients with significant visual impairment or other physical disability that precludes complete cooperation

Study Objectives The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease. Conditions: Cervical Cancer, Genital Warts Intervention / Treatment: BIOLOGICAL: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion Criteria: * Female with an intact uterus with lifetime history of 0-4 sexual partners Exclusion Criteria: * Prior Human Papillomavirus Vaccine (HPV) vaccination; * Prior abnormal paps; * Prior history of genital warts

Study Objectives RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining vaccine therapy with chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This clinical trial is studying how well giving vaccine therapy together with paclitaxel, carboplatin, and radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed with surgery. Conditions: Lung Cancer Intervention / Treatment: BIOLOGICAL: recombinant fowlpox GM-CSF vaccine adjuvant, BIOLOGICAL: recombinant fowlpox-CEA(6D)/TRICOM vaccine, BIOLOGICAL: recombinant vaccinia-CEA(6D)-TRICOM vaccine, DRUG: carboplatin, DRUG: paclitaxel, RADIATION: radiation therapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * Stage III (locally advanced) disease * Unresectable disease * Carcinoembryonic antigen (CEA)-positive (staining ≥ 20% of cells) tumor by immunohistochemistry * HLA-A2-positive * No distant metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 6 months Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Absolute lymphocyte count ≥ 600/mm\^3 * Hemoglobin ≥ 10 g/dL Hepatic * Bilirubin \< 1.5 mg/dL * AST ≤ 2 times upper limit of normal * Hepatitis B and C negative Renal * Creatinine normal OR * Creatinine clearance \> 60 mL/min Cardiovascular * No unstable or newly diagnosed angina pectoris * No myocardial infarction within the past 6 months * No New York Heart Association class II-IV congestive heart failure Immunologic * HIV negative * No altered immune function * No active or history of eczema * No atopic dermatitis * No autoimmune disease, including any of the following: * Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia * Systemic lupus erythematosus * Sjögren's syndrome * Scleroderma * Myasthenia gravis * Goodpasture's syndrome * Addison's disease * Hashimoto's thyroiditis * Active Graves' disease * Multiple sclerosis * No known history of allergy or serious reaction to prior vaccination with vaccina * No known allergy to eggs * No active or history of extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin condition Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 months after study participation * No history of seizures or encephalitis * Able to avoid close household contact with the following individuals for at least 3 weeks after vaccinia vaccination: * Children under 3 years of age * Pregnant or nursing women * Individuals with a history of or active eczema or other eczematoid skin disorders * Individuals with other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, impetigo, burns, varicella zoster, severe acne, or other open rashes or wounds) * Immunodeficient or immunosuppressed individuals, including HIV-positive persons, by disease or therapy * No other active malignancy within the past 2 years * No other concurrent serious illness PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 years since prior immunotherapy with related vaccinia and fowlpox vaccines * At least 3 years since prior antigen-specific peptides * No other concurrent immunotherapy Chemotherapy * No prior paclitaxel or carboplatin for lung cancer * At least 3 years since prior chemotherapy * No other concurrent chemotherapy Endocrine therapy * No concurrent steroids, except for any of the following: * Topical steroids * Inhaled steroids for mild or moderate asthma * Dexamethasone as premedication for paclitaxel OR for short-term doses (48-72 hours in duration) to control refractory nausea that is not responding to other antiemetics * Systemic corticosteroids for ≥ grade 3 radiation pneumonitis * No steroid eye-drops for at least 3 weeks after vaccinia vaccination * No concurrent hormonal therapy * No concurrent systemic glucocorticoids Radiotherapy * No prior radiotherapy to the lung fields * No prior thoracic radiotherapy for lung cancer * No other concurrent radiotherapy Surgery * Surgical scars must be healed * No prior splenectomy * No concurrent major surgical procedure Other * Recovered from all prior therapy * No other concurrent anticancer agent or therapy

Study Objectives The purpose of the study is to reduce the incidence of postoperative constipation by systematic nurse assessment, interventions and evaluation, in the first month after thoracic surgery. Conditions: Postoperative Constipation Intervention / Treatment: PROCEDURE: Degree of constipation Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: NON_RANDOMIZED Interventional Model: FACTORIAL Masking: NONE

Inclusion Criteria: * Patients admitted for planned lung surgery * Patients are capable * Able to talk and understand Danish Exclusion Criteria: * Patients with colostomy and / or ileostomy * Neurological or abdominal diseases * Feed through a tube

Study Objectives This pilot study is designed to evaluate outcomes with the combination of CPX-351 salvage therapy and haplo-cord graft stem cell transplantation for subjects with relapsed or refractory AML or myelodysplastic syndrome. Conditions: Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia, Relapsed Adult Acute Myeloid, Myelodysplastic Syndromes, Previously Treated Intervention / Treatment: DRUG: CPX-351, DRUG: Fludarabine, DRUG: Melphalan, DRUG: Rabbit Anti-Human T-Lymphocyte Globulin, BIOLOGICAL: Haplo-Cord Stem Cell Transplantation 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: 1. Subject must have refractory or relapsed Acute Myeloid Leukemia (AML) according to previously established criteria: 1. Primary induction failure (PIF) after ≥ 2 cycles of chemotherapy 2. First relapse 3. Relapse refractory to salvage chemotherapy 4. Second or subsequent relapse 2. Subjects with Myelodysplastic Syndrome (MDS): (a) Either Refractory Anemia with Excess Blasts I or Refractory Anemia with Excess Blasts II (RAEB I or RAEB II) 3. Karnofsky performance status ≥ 70 4. Willing to participate as a research subject and sign an informed consent form 5. Adequate physical function measured by: 1. Cardiac: asymptomatic, or if symptomatic then Left Ventricular Ejection Fraction (LVEF) at rest must be ≥ 45% and must improve with exercise 2. Hepatic: ≤3 x upper limit of normal (ULN) alanine aminotransferase (ALT) and ≤ 1.5 total serum bilirubin, unless liver is involved with the disease or there is congenital benign hyperbilirubinemia 3. Renal: serum creatinine within normal range, or if serum creatinine is outside the normal range, then calculated creatinine clearance ≥ 60 ml/min 4. Pulmonary: asymptomatic, or if symptomatic, diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 45% of predicted (corrected for hemoglobin) 6. If subject has prior malignancy, must be without any evidence of disease of that prior malignancy for at least 2 years (excludes skin cancers that may have been excised within that 2 year period). Exclusion Criteria: 1. Serious active or uncontrolled infection or medical condition 2. Women who are pregnant or breast feeding. Women of childbearing age must use adequate contraception and have a negative pregnancy test. 3. Prior daunorubicin therapy with a cumulative dose of more than 368 mg/m2 or equivalent 4. Other systemic anticancer therapy or ongoing clinically relevant toxicities from such therapy (at discretion of the investigator) 5. History of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, congestive heart failure), resulting in heart failure by New York Heart Association Class III or IV staging. 6. Subjects with Wilson disease or other Copper-related disorders.

Study Objectives This is a study to determine the optimal treatment for patients with advanced stage or recurrent endometrial cancer. Traditionally, patients have been treated with either hormonal therapies (megesterol) or chemotherapy (paclitaxel and carboplatin). This study investigates the effectiveness of the combination of hormonal therapy and chemotherapy. This study also will examine the side-effects associated with these drugs and the quality of life of patients on combination therapy. Conditions: Uterine Cancer Intervention / Treatment: DRUG: Paclitaxel ,Carboplatin , Megesterol Acetate Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have biopsy proven endometrioid adenocarcinoma or adenosquamous carcinoma. * Patients must have evidence of primary FIGO Stage III-IVB or recurrent endometrial cancer. * Patients with non-measurable disease following complete cytoreduction at the time of initial operative management for Stage III-IVB are eligible. * Patients with recurrent disease must have disease confirmed by one of the following: 1. CT Scan 2. MRI 3. PET Scan 4. Physical Exam * Patients must have adequate organ function defined as: 1. Platelets \>/= 100,000/1 2. Granulocytes (ANC) \>/= 1,500/ 3. Creatinine \</= 1.6mg/dl 4. SGOT (AST) \</= 3x upper limits of normal 5. Bilirubin within institutional normal limits * Patients must have adequate performance status (ECOG performance status 0-2. * Patients must be age 19 or greater and have signed informed consent. Exclusion Criteria: * Patients with history of other malignancies (except non-melanoma skin cancer or carcinoma-in-situ of the cervix) are ineligible. * Patients with high-risk histologic subtypes of endometrial cancer, namely papillary serous or clear cell histology are ineligible. * Patients with evidence of uterine sarcoma, including leiomyosarcoma, carcinosarcoma, endometrial stromal sarcoma, and adenosarcoma are ineligible. * Patients who are less than 8 weeks after the completion of radiotherapy are ineligible. * Patients receiving any other investigational agents are ineligible. * Patients with known hypersensitivity to paclitaxel, carboplatin, or megesterol are ineligible. * Patients with uncontrolled current illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, serious peripheral neuropathy, or psychiatric illness/social situations that would limit or preclude compliance with study requirements are ineligible.

Study Objectives Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had already been treated at the Ambulatory of Botucatu School of Medicine were selected. The measuring tool used for the level of physical activities was the International Physical Activities Questionnaire (IPAQ-short version), validated by the World Health Organization - Physical Activities and Health International Committee (1998). Conditions: Breast Cancer Intervention / Treatment: DRUG: IPAQ Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: Allocation: NA Interventional Model: SINGLE_GROUP Masking: SINGLE

Inclusion Criteria: * Patients whit diagnosis of breast cancer

Study Objectives The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC). Conditions: Non-small Cell Lung Cancer Intervention / Treatment: DRUG: carboplatin, DRUG: paclitaxel, DRUG: sunitinib Location: Canada, United States, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically proven NSCLC * Stage IIIB (locally advanced with malignant effusion) or Stage IV disease * No prior therapy for NSCLC * Evidence of unidimensionally measurable disease Exclusion Criteria: * Previous treatment with systemic chemotherapy for lung cancer * History of or known brain metastases * NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment * Evidence of hemoptysis within 4 weeks of starting study treatment * Serious acute or chronic illness or recent history of significant cardiac abnormality * Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of EGFR and PDGFR

Study Objectives This study is a randomized controlled trial (RCT) with the aim of determining the cultural sensitivity, feasibility, and effectiveness of an expressive writing intervention for Chinese breast cancer survivors. Conditions: Breast Cancer, Breast Neoplasms Intervention / Treatment: BEHAVIORAL: Self-Regulation Condition, BEHAVIORAL: Enhanced self-Regulation Condition Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: 1) having a breast cancer diagnosis; 2) completing breast cancer surgery within five years; and 3) being comfortable writing and speaking Chinese (i.e. Mandarin or Cantonese)

Study Objectives Primary Objective: To evaluate the improvement in progression-free survival (PFS) of aflibercept versus placebo in participants with metastatic colorectal cancer treated with FOLFIRI as second-line treatment for metastatic disease. Secondary Objectives: To compare the overall survival (OS) in the 2 treatment arms. To compare the overall response rate (ORR) in the 2 treatment arms. To assess the safety profile of the 2 treatment arms. To assess immunogenicity of intravenous (IV) aflibercept in selected centers. Conditions: Colorectal Cancer Metastatic Intervention / Treatment: DRUG: Aflibercept, DRUG: Placebo Location: Taiwan, Hong Kong, Singapore, China, Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: DOUBLE

Inclusion criteria: * Histological or cytological proven adenocarcinoma of the colon or rectum. * Metastatic disease that was not amenable to potentially curative treatment. * One and only one prior chemotherapeutic regimen for metastatic disease. This prior chemotherapy must be an oxaliplatin containing regimen. Participants who were relapsed within 6 months of completion of oxaliplatin based adjuvant chemotherapy were eligible. Exclusion criteria: * Prior therapy with irinotecan. * Eastern Cooperative Oncology Group (ECOG) performance status \>1. * Less than 28 days elapsed from prior radiotherapy, from prior surgery and prior chemotherapy to the time of randomization. Less than 42 days elapsed from prior major surgery to the time to randomization. * Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.3.0) at the time of randomization. * Age \<18 years. * History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease. * Other prior malignancy. Adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or any other cancer from which the participants had disease free for \> 5 years were allowed. * Participation in another clinical trial with an investigational drug and any concurrent treatment with any investigational drug within 30 days prior to randomization. * Any of the following within 6 months prior to randomization: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association Functional Classification (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack. * Any of the following within 3 months prior to randomization: treatment resistant peptic or duodenal ulcer disease, erosive oesophagitis or gastritis, grade 3 or 4 gastrointestinal bleeding/hemorrhage, gastrointestinal perforation/fistula, abdominal abscess, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event. * Participants who had given high dose of aspirin or non steroidal anti-inflammatory agents (NSAIDS) or high steroids within 4 weeks prior to randomization. The definition of "high dose" was to be based on the investigator's judgment. * Occurrence of deep vein thrombosis within 4 weeks, prior to randomization. * Inadequate organ or bone marrow function. * Pregnant or breast-feeding woman. Positive serum or urine pregnancy test prior to randomization. Participants with reproductive (M/F) who were not agree to use accepted and effective method of contraception during the study treatment period and for at least 6 months following completion of study treatment. * Uncontrolled hypertension. * Urine Protein: creatine ratio (UPCR) \>1 on morning spot urinalysis or proteinuria \> 500mg/24 hours. * Participants on anticoagulant therapy with unstable dose of warfarin and/or having an out-of-therapeutic range international normalized ratio (INR) (\>3) within 4 weeks prior to randomization. * Evidence of clinically significant bleeding diathesis or underlying coagulopathy. * Known dihydropyrimidine dehydrogenase deficiency. * Predisposing colonic or small bowel disorder in which the symptoms were uncontrolled as indicated by baseline of \> 3 loose stools daily. * Prior history of chronic enteropathy, inflammatory enteropathy, chronic diarrhea, unresolved bowel obstruction/sub-obstruction, more than hemicolectomy, extensive small intestine resection with chronic diarrhea. * History of anaphylaxis or known intolerance to atropine sulphate or loperamide or appropriate antiemetics to be administered in conjunction with FOLFIRI. * Treatment with concomitant anticonvulsant agents that were cytochrome P450 3A4 (CYP3A4) inducers (phenytoin, phenobarbital, carbamazepine), unless discontinued \> 7 days. * Participants with known Gilbert's syndrome. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Objectives The purpose of the study in Phase I is to select the recommended dose of bortezomib in combination with melphalan and prednisolone in Japanese participants. In Phase II, to assess the effectiveness and safety of the recommended dose of bortezomib (selected in the phase I portion). Conditions: Multiple Myeloma Intervention / Treatment: DRUG: JNJ-26866138 0.7 mg/m2, DRUG: JNJ-26866138 1.0 mg/m2, DRUG: JNJ-26866138 1.3 mg/m2, DRUG: Melphalan, DRUG: Prednisolone Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Participants diagnosed with symptomatic or nonsecretory multiple myeloma * Participants who have not received chemotherapy and are not hematopoietic stem cell transplantation candidates * Participants with a measurable lesion * Life expectancy greater than or equal to 3 months Exclusion Criteria: * Previously received treatment for Multiple Myeloma * Greater than or equal to Grade 2 peripheral neuropathy or neuropathic pain * Myocardial infarction within 6 months prior to enrollment or uncontrolled angina, severe uncontrolled ventricular arrhythmias, or clinically significant conduction system abnormalities * Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection * Active prior malignancy diagnosed within the last 5 years * Female participant who is pregnant or breast-feeding * Participant is enrolled in another clinical research study and/or is receiving an investigational agent

Study Objectives Two metaanalyses of studies on the prognostic significance of circulating cancer cells in colorectal cancer indicated, that the presence of circulating tumour cells (CTC) in the peripheral blood is the negative prognostic factor. However there is no sufficient evidence that disseminated tumour cells (DTC) in the bone marrow of the colorectal cancer patients influence the prognosis. There is the evidence that right-sided and left- sided cancers may have different biology and different prognosis. Therefore in this study the investigators concentrated on the left colon and rectum locations with the locally advanced cancer being the main area of interest. The aim of this study was to analyse the relation of DTC with the tumor characteristics, cancer progression and survival in left sided colorectal cancer. Conditions: Colorectal Cancer, Bone Marrow Tumor Cell Infiltration Intervention / Treatment: DIAGNOSTIC_TEST: Bone marrow analysis to identify disseminated tumour cells Location: Poland Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * age \> 18 years * histologically proven left-sided colorectal cancer * signed informed consent Exclusion Criteria: * synchronous right sided colon cancer * history of other neoplasm * inability to understand and sign informed consent

Study Objectives The main objective of this study is to evaluate the change of neutrophil to lymphocyte ratio (NLR) after 6-week treatment of immune checkpoint inhibitors (ICIs) with or without immunomodulatory drugs and recognize the effect of post-treatment NLR and overall survival in advanced lung cancer patients by retrospective review. Conditions: Advanced Lung Cancer Intervention / Treatment: Location: Taiwan Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria * Aged 20 years and older. * Patients who have been given a diagnosis of lung cancer. * Previously advanced lung cancer patients first treated with ICIs from Oct 1, 2015 to Oct 31, 2019. Exclusion Criteria * Patients who have no hematological laboratory data available at baseline (within 3 days prior to ICI treatment) and the 6th week (± 2 weeks) after ICI treatment initiation.

Study Objectives This study will assess the occurrence of multiple symptoms in cancer patients of 5 German university hospitals. Primary goal of the study is to assess the prevalence of multiple symptoms and related symptom clusters (e.g. pain, fatigue and sleep disorder). Conditions: Cancer Intervention / Treatment: Location: Germany Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * cancer patients (ICD 10) * 18 to 80 years of age * ongoing treatment * informed consent Exclusion Criteria: * not speaking and writing German

Study Objectives This is a clinical trial to evaluate the intravenous administration of indocyanine green (ICG) as a method of intra-thoracic lesion localization. The primary purpose is to determine if intravenous ICG allows us to identify intra-thoracic lesions. Conditions: Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple Intervention / Treatment: DRUG: ICG Intervention, DEVICE: Near Infrared Camera Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: DEVICE_FEASIBILITY Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients with intra-thoracic lesions that require resection for therapeutic or diagnostic purposes as recommended by their thoracic surgeon. * 18 years of age or older * Documented, signed, dated informed consent obtained prior to any study specific procedures being performed Exclusion Criteria: * Subjects who do not wish to have subsequent surgical resection * A medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the treating surgeon, makes resection unreasonably hazardous for the patient * Pre-operative spirometry that suggests the patient is at high risk or cannot undergo resection of the primary tumor. * Iodide or seafood allergy

Study Objectives This research seeks to determine if a combination of low-dose ibuprofen along with a structured home-based walking and progressive resistance exercise program, EXCAP, will be effective in reducing cognitive difficulties among cancer patients receiving chemotherapy. Conditions: Cancer-related Cognitive Difficulties Intervention / Treatment: DRUG: Ibuprofen, BEHAVIORAL: Home-Based Exercise, DRUG: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: FACTORIAL Masking: DOUBLE

Inclusion Criteria: * Must report cognitive difficulties of 3 or higher on a 0-10 scale * Must provide informed consent * Be able to read English * Have a primary diagnosis of cancer * Be able to swallow medication * Women of child-bearing potential must not be pregnant or become pregnant during the 6 week study * Agree not to take NSAIDs during the 6 week intervention period * Be scheduled to receive at least 2 additional cycles of oral or IV chemotherapy over the 42-day study period. * Must have the approval of their treating physician to begin the exercise program and receive the ibuprofen * Must be over 18 years of age Exclusion Criteria: * Currently taking a consistent dosage of a NSAID at least 3 days a week for the last 3 months that is over 400mg daily * Have an allergy to ibuprofen * Be identified as in active or maintenance stage of exercise behavior as assessed by the single-item exercise stages of change short form * have physical limitations that contraindicate participation in sub-maximal physiological fitness testing or a low to moderate home-based walking and progressive resistance program * have a history of peptic ulcer disease within the last 12 months * Diagnosed with a neurodegenerative disease * Had a myocardial infraction within the past 6 months * Patients with a neutropenic episode during the first cycle of chemotherapy or at high risk for a neutropenic episode during future chemotherapy cycles at the treating physicians discretion * Have confirmed metastatic disease to the central nervous system * Have been hospitalized for a major psychiatric illness within the last 5 years

Study Objectives RATIONALE: Oxandrolone and megestrol may help prevent weight loss and improve quality of life in patients with cancer. It is not yet known whether oxandrolone is more effective than megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors. PURPOSE: This randomized phase III trial is studying oxandrolone to see how well it works compared to megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors. Conditions: Unspecified Adult Solid Tumor, Protocol Specific, Weight Changes Intervention / Treatment: DRUG: Megestrol Acetate, DRUG: Oxandrolone 20 mg Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: FACTORIAL Masking: NONE

INCLUSION CRITERIA: * Age \>18 years with no pre-existing or uncontrolled medical or psychological illness that would impair a patient's ability to provide informed consent or to complete protocol therapy or quality of life questionnaires. * A minimum of one month planned chemotherapy remaining at the time Oxandrin or Megestrol acetate is begun. Oral chemotherapy medications, biologicals, and monoclonal antibodies are included in eligibility criteria. * Histologically confirmed solid tumor (see exceptions in ineligibility list) * Female patients with a history of breast cancer, gynecologic cancer, and hormonally responsive germ cell tumors must be disease free \> 5 years to be eligible for this study * Patients with non-melanoma skin cancers and carcinoma in situ of the cervix are eligible. * History of weight loss of: 1. \> 5% total body weight during the previous 6 months OR 2. \> 3% in previous month OR 3. Progressive weight loss on 2 consecutive visits despite attempts at dietary, behavioral, or pharmacologic intervention. * ECOG Performance Status of 0-2 * Life expectancy \> 6 months * Serum creatinine \< 2.5mg/dl, SGOT and SGPT \< 2 times upper limit of normal, total bilirubin \< 2.5 mg/dl * Patients must be able to swallow 1 tablet twice a day or 20 cc of liquid each day * Patients must be able to meet their nutritional requirements via the oral route with food and/or oral supplements or via enteral tube feedings. However, Oxandrin pills must be administered orally. * Patients who are taking warfarin for maintenance of central venous catheter patency are eligible for this trial if their INR \< 1.2. Because of the interaction between warfarin and Oxandrin, the maintenance dose of warfarin in eligible patients should be halved to keep the INR at 1-1.2. For example, if a patient is taking 1 mg of warfarin at study entry, it is recommended that the dose be decreased to 0.5 mg per day, their dose should be decreased to every other day, every third day, etc. to keep the INR at \< 1.2. The INR must be checked weekly until stable at \< 1.2. * Patients can be receiving concurrent RT. EXCLUSION CRITERIA: * Ongoing or planned treatment with corticosteroid medications, estrogens, progestins (including Megestrol acetate) or any other steroid hormone during the study period. Patients who receive intermittent corticosteroids as part of a pre-chemotherapy antiemetic regimen are eligible for this study. Patients treated with Oxandrin or Megestrol acetate \< 3 months before study entry are not eligible. Patients taking dronabinol or any other appetite stimulant must be off medication for a minimum of 3 days prior to start of study medication. * Patients who have had the following are ineligible: * Prostate cancer * Male breast cancer * Female breast, gynecologic, or hormonally responsive germ cell tumors in the last 5 years * Primary or metastatic malignant brain tumors that have not been stable or demonstrate progressive disease in the last 6 months. * Leukemia, lymphoma, myeloma or other hematologic malignancies * Men \> 40 years of age should have a prostate-specific antigen (PSA) level checked if not monitored in the past year. Those patients with PSA \> 4 ng/mL will be excluded from participation in the study. If required, the PSA should be done within 2 weeks prior to registration. * Patients with hypercalcemia, nephrosis or the nephrotic phase of nephritis or uncontrolled hypertension, congestive heart failure, pulmonary edema, unstable angina or Cushing's syndrome. * Patients with recent (within 6 months) active thromboembolic disease or recent myocardial infarction (within 3 months of study entry). * Systemic anticoagulation: Patients currently on oral anticoagulants (warfarin) are not eligible unless they are taking low doses of warfarin for catheter patency. If a patient develops thromboembolic disease while on treatment, they may remain on study. It is recommended that they receive a standard loading dose of coumadin on day 1. because of the interaction between Oxandrin and Coumadin (Oxandrin elevates the INR), patients will subsequently require a much lower dose of Coumadin. The effect of these combined medications should develop within 24 to 48 hours. The recommended Coumadin dose should be decreased to 20% of what is normally required for sufficient anticoagulation. (Example: If patient would normally receive 5 mg every day, they should only receive 1 mg every day.) PT/INR results should be monitored frequently with dosage adjustment as needed. * Significant ascites, pleural effusions or edema which may inhibit oral food intake or invalidate weight determinations. * Diabetic medications are allowed, however patients taking sulfonyureas are ineligible. Below is a list of commonly used sulfonyureas (Note: This is a helpful guide, not a complete list.): Glimepiride (Amaryl®), glyburide (DiaBeta®), chlorpropamide (Diabinese®), glipizide(Glucatrol®), combined glyburide and metformin (Glucovance®) and orinase (Tolbutamide®). There is no contraindication for concomitant use of insulin and oxandrolone (Oxandrin®) if required by the patient. Any patient on insulin or other oral hypoglycemics should self-monitor to prevent hypo \& hyperglycemia. * Patients who are pregnant or nursing. * Patients with history of priapism (persistant erections) and sickle cell anemia. * Patients with a BMI(Body Mass Index) ≥ 35

Study Objectives This is a prospective registry of all patients who endoscopic submucosal dissection (ESD), per-oral endoscopic myotomy (POEM) and gastric per-oral endoscopic myotomy (G-POEM) using ConMed Electrosurgical unit for submucosal Dissection at Baylor St Luke's Medical Center. Collected information includes; procedure technical success rate, duration, periprocedural complications and ease of use. Conditions: Gastrointestinal Neoplasms, Achalasia, Gastroparesis Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Patient is ≥ 18 years old * Patient is capable of providing informed consent * Patient is referred for endoscopic submucosal dissection, per-oral endoscopic myotomy, or gastric per-oral endoscopic myotomy Exclusion Criteria: * Patient is \< 18 years old * Patient refused and/or unable to provide consent * Patient is a pregnant woman

Study Objectives The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison). Conditions: Actinic Keratoses Intervention / Treatment: DRUG: Metvix and natural daylight PDT, DRUG: Metvix and conventional PDT Location: Australia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: SINGLE

Inclusion Criteria: 1. Male or female above 18 years; 2. Subject with clinical diagnosis of mild AK on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs); Exclusion Criteria: 1. Subject with clinical diagnosis of at least one severe AK on TAs 2. Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs; 3. Subject with pigmented AK on the TAs

Study Objectives The majority of patients with Hodgkin Lymphoma (HL)are cured with radiation therapy and/or combination chemotherapy. However, patients who relapse after attaining a complete remission with chemotherapy and those with primary refractory disease have a poor outcome with conventional chemotherapy regimens. Treatment results with standard-dose second-line regimens produce low complete remission rates and minimal survival benefit. Single institution studies have shown better outcome after autologous stem cell transplant in this group of patients when compared to historical controls receiving conventional treatment. In this retrospective review, we aim to analyze outcome and determine independent prognostic factors which would correlate with the long-term outcome of patients with HL who received an autologous stem cell transplant in the past at the Royal Marsden Hospital Eligible patients (those on current-follow-up) identified from the transplant database will be eligible for the study. Accrual of eligible patients currently under follow-up will be performed in clinic at the time of next appointment. All patients accrued will give informed consent to participate in the study for retrospective case note review, after discussion with a study investigator and after receiving a study information sheet. The results of the analysis will be published in a peer-reviewed medical journal. Conditions: Hodgkin Lymphoma Intervention / Treatment: PROCEDURE: Autologous stem cell transplant Location: United Kingdom Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * a) Age over 18 b) Patients with Hodgkin Lymphoma who have received an autologous stem cell transplant c) Informed written consent Exclusion Criteria: * a) Medical or psychiatric conditions that compromise the patient's ability to give informed consent b) HIV positive or AIDS related lymphoma

Study Objectives The investigators are enrolling 3-12 month old infants with a diagnosis of tuberous sclerosis complex (TSC) for a new study on early markers of autism. The study is looking for early signs for autism in a population (TSC) where autism is common. The goal of this project is to use behavioral testing, MRI and EEG techniques to identify children at risk for developing autism starting at 3 months of age and continuing until 36 months of age. Throughout the study, the investigators will recommend Early Intervention services for any child who shows early signs of autism. Conditions: Tuberous Sclerosis Complex Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: 1. Meets genetic or clinical diagnostic criteria for TSC (Tuberous Sclerosis), the latter based on current recommendations for diagnostic evaluation, such as physical exam, neuroimaging, echocardiogram. 2. Age criteria: 3 months- 12 months of age at time of enrollment. For study purposes, 3 months is defined as ≥ 9 weeks, 1 day and 12 months is defined as ≤ 13.5 months. Exclusion Criteria: 1. Prematurity, defined as gestational age \< 36 weeks at time of delivery 2. Has taken an investigational drug as part of another research study, within 30 days prior to study enrollment 3. Is taking an mTOR inhibitor such as rapamycin, sirolimus, or everolimus (other than topical formulations) at the time of study enrollment 4. Subependymal Giant Cell Astrocytoma requiring medical or surgical treatment at the time of study enrollment 5. History of epilepsy surgery at the time of study enrollment 6. Contraindications to MRI scanning, such as metal implants/non-compatible medical devices or medical conditions

Study Objectives This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology. Conditions: Breast Cancer Female Intervention / Treatment: DEVICE: Investigational WF-OCT device Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Female * Age 18 years or older * Invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery * May include neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation) * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Metastatic cancer (Stage IV) * Lobular carcinoma as primary diagnosis

Study Objectives The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt: * Incidence of adverse events under actual conditions of use (Serious and Nonserious Adverse Events); * Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected Adverse Reaction); * Adverse Event caused by misuse, abuse, or drug interactions; * Other information concerned with safety or efficacy. Conditions: Glioblastoma, Glioma, Astrocytoma Intervention / Treatment: DRUG: Temozolomide, RADIATION: Radiotherapy Location: Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Participants who are prescribed with temozolomide by local labeling: * participants with newly diagnosed glioblastoma multiforme; * participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. Exclusion Criteria: * N/A

Study Objectives An early feasibility study to evaluate feasibility, radiotherapy benefits and safety when using TraceIT tissue spacer to create space between pancreas and duodenum in patients with localized Pancreatic Cancer. Conditions: Pancreatic Cancer Intervention / Treatment: DEVICE: TraceIT Tissue Spacer implantation 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: 1. Age ≥18 years old 2. Biopsy-confirmed localized pancreatic cancer in the head or neck of the pancreas as defined by the NCCN guidelines 3. Tumor is clearly delineable from duodenum and no clear evidence of invasion of the duodenum is seen at time of EUS performed for either diagnosis or fiducial placement. 4. Subject is able to comply with motion management guidelines. 5. Radiotherapy or chemoradiotherapy for treatment of the disease is indicated. 6. In Investigator's opinion, medically fit to undergo endoscopy for fiducial marker implantation and TraceIT administration. 7. Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria: 1. White blood cell count: ≥ 3.0 x 109/L 2. Absolute neutrophil count (ANC): ≥ 1.5 x 109/L 3. Platelets: ≥ 100 x 109/L 4. Total bilirubin: ≤ 2.0 times upper limit of normal (ULN) 5. AST and ALT: ≤ 3.0 times institutional upper normal limit 6. Serum creatinine: \< 1.5 times ULN e 7. INR: \< 1.5 8. Serum pregnancy: Negative 9. Hemoglobin: ≥ 8.0 g/dl 8. Zubrod Performance Status 0-2 9. Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site. 10. Life expectancy of at least 9 months Exclusion Criteria: 1. Patients for whom radiotherapy is contraindicated 2. Previous thoracic or abdominal radiotherapy 3. Any GI abnormality that would interfere with the ability to access the injection site 4. Presence of tumor invasion of the duodenum detected on EUS at time of biopsy 5. Previous Whipple procedure or other resection of pancreatic tumor prior to screening 6. Active gastroduodenal ulcer or uncontrolled watery diarrhea 7. History of Chronic Renal Failure. 8. Documented history of uncontrolled diabetes (i.e., symptomatic hyperglycemia that cannot be medically managed, fasting blood glucose level above 300 mg/dL, and/or frequent swings between hyperglycemia and hypoglycemia) 9. Currently enrolled in another investigational drug or device trial that clinically interferes with this study. 10. Unable to comply with the study requirements or follow-up schedule. 11. Any condition or comorbidity that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject. 12. Women who are pregnant or breast-feeding; women of child-bearing age must use contraceptives.

Study Objectives This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It has been found that some people with NSCLC have a change (mutation) in a certain gene called the RET gene. This mutated gene may help cancer cells grow. Only participants with a RET mutation will be allowed to participate. In this study, investigators are testing the strategy of using a study drug designed to inhibit or shut off growth signals that results from the mutated RET gene. Ponatinib is an anti-cancer drug that has been used in research studies for other types of cancer. Ponatinib blocks several growth signals in cancer cells, including RET. In this research study, investigators are looking to see whether ponatinib is effective and safe in treating NSCLC harboring RET rearrangements. Conditions: Non Small Cell Lung Cancer Intervention / Treatment: DRUG: Ponatinib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically or cytologically confirmed advanced NSCLC * Molecular confirmation of a RET translocation * At least one measurable lesion as defined by RECIST * No restriction on number of prior therapies * Estimated life expectancy of at least 12 weeks * Able to swallow and retain orally administered medication * Must agree to use an effective form of contraception from enrollment through 30 days after the end of study treatment * Willingness and ability to comply with scheduled visits and study procedures Exclusion Criteria: * Clinically significant gastrointestinal abnormalities * Pregnant or breastfeeding * Major surgery within 28 days of initiating therapy * History of CNS disease (Note: Participants with brain metastases will be eligible if treated appropriately and if they remain clinically stable). * Anti-cancer therapy within 3 weeks * History of significant bleeding disorder unrelated to cancer * History of acute pancreatitis within 1 year of study entry or history of chronic pancreatitis * History of alcohol abuse * Uncontrolled hypertriglyceridemia * History of arterial thrombotic events (myocardial infarction, stroke or peripheral vascular disease). * Uncontrolled hypertension * Taking medications that are known to be associated with Torsades de Pointes * Ongoing active infection * Diagnosed with or received anti-cancer therapy for another primary malignancy within 3 years prior to entry (except for non-melanoma skin cancer or in situ cancers) * Any condition or illness tha could compromise patient safety or interfere with the evaluation of the drug