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Study Objectives Study PT-112-102, a multicenter, open-label dose-finding and pharmacokinetic study of PT-112 in patients with relapsed or refractory multiple myeloma. This is designed as a two-part study. In the first part of the study, cohorts of three patients (expanded to six patients in the event of a dose-limiting toxicity) will receive escalating doses of PT-112 until the MTD is reached, based on tolerability observed during the first 28 days of treatment. In the second part of the study, an expansion cohort of 14 patients will be treated at the recommended dose to confirm the tolerability of treatment and evaluate evidence of treatment efficacy. Conditions: Multiple Myeloma Intervention / Treatment: DRUG: PT-112 Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Key Inclusion Criteria: 1. Previously diagnosed with MM requiring treatment based on IMWG diagnostic criteria; 2. Relapsed or refractory MM after adequate exposure to and therapeutic response (following IMWG response criteria) to at least one line of treatment with one or more active agents, including alkylating drugs, corticosteroids, immunomodulatory drugs (IMiD: thalidomide, lenalidomide, pomalidomide), proteasome inhibitors (bortezomib, cartilzomib), and monoclonal antibodies (daratumumab, elotuzumab, ixazomab); 3. Evaluable MM with at least one of the following: (a) serum monoclonal component ≥ 0.5 g/dL; or (b) Bence Jones (BJ) proteinuria ≥ 200 mg/24h; or (c) measurable plasmacytoma (not previously irradiated); or (d) involved serum free light chain ≥ 10 mg/dL with an abnormal free light chain ratio; 4. ECOG Performance Status (PS) 0-2; 5. Life expectancy \> 3 months; 6. At least 2 weeks (or 5 half-lives, whichever is longer) wash-out since the end of previously administered experimental therapy (6 weeks if previous nitrosourea containing regimen) or 2 weeks for standard-of-care regimens. Concurrent corticosteroids are allowed provided they are administered at an equivalent prednisone dose of ≤ 10 mg/day, as prediction or blood products only; 7. Recovery from non-hematologic toxic effects of prior therapy to grade ≤ 1 (except alopecia) by NCI CTCAE Version 4.03; 8. Adequate bone marrow (BM), renal, hepatic and metabolic function. Key Exclusion Criteria: 1. Any of the following concomitant diseases/conditions: * History or presence of myocardial infarction, clinically relevant valvular heart disease, or congestive heart failure within the last 12 months; * Unstable cardiac dysrhythmias or persistent prolongation of the corrected QT interval (QTc) (Fridericia) to \>480 msec for males or \>500 msec for females, based on ECG at screening (patients with stable atrial fibrillation on treatment are allowed provided they do not meet any other cardiac or prohibited drug exclusion criterion); * Presence of current angina; * Active uncontrolled infection; * Morphological or cytological features of myelodysplasia and/or post-chemotherapy aplasia on BM assessment; * Myopathy \> grade 2 or any clinical situation that causes significant and persistent elevation of CPK (\>2.5 x ULN in two different determinations performed one week apart); * Peripheral neuropathy \> grade 1, except for grade 2 without limitations on instrumental daily life activities; * POEMS syndrome or active plasma cell leukemia; * Chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHD; * History or presence within the last 3 months of Deep Vein Thrombosis (DVT) or a pulmonary embolism (PE);- Uncontrolled leptomeningeal disease; * Uncontrolled disease-related metabolic disorder (e.g., hypercalcemia); * Acute or chronic infections requiring systemic therapy, including, among others: * active infection requiring systemic therapy; * history of testing positive to human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome; * hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is positive); * active tuberculosis (history of exposure or history of positive TB test with presence of clinical symptoms, physical or radiographic finding); * Any other major illness that, in the Investigator's judgment, may substantially increase the risk associated with the patient's participation in this study; 2. History of prior malignancy other than those previously treated with a curative intent more than 5 years ago and without relapse (any tumor) or basal cell skin cancer, in situ cervical cancer, superficial bladder cancer, or high grade intestinal polyps treated adequately, regardless of the disease-free interval; 3. Prior irradiation to \> 30% of BM reserves (including total body irradiation), regardless of the washout period; 4. High dose chemotherapy followed by autologous stem cell transplantation within 90 days prior to initiating study treatment; 5. Bisphosphonate treatment within 7 days prior to initiating study treatment (while on study, bisphosphonates can be administered only once a month, between Days 18 to 21 of the 28-day treatment cycle)

Study Objectives The purpose of this dose-escalation study is to assess the safety and tolerability of treatment with Chidamide in a range of doses combined with CHOP in fixed dose in patients with newly diagnosed peripheral T-cell lymphoma. Conditions: Peripheral T-cell Lymphoma Intervention / Treatment: DRUG: Chidamide, DRUG: cyclophosphamide, DRUG: adriacin, DRUG: vincristine, DRUG: prednisone Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: 1. Male and female aged 18-65 years old; 2. Histopathologically confirmed Peripheral T -cell Lymphoma (PTCL) including: * PTCL-unspecified; * Angioimmunoblastic T-cell lymphoma; * Anaplastic large cell lymphoma, ALK positive or negative; * Subcutaneous panniculitis T-cell lymphoma; * Cutaneous / T-cell lymphoma; * Other T-cell lymphoma that investigators consider to be appropriate to be enrolled; 3. Patients have not received anti-tumor therapy; 4. In any Ann Arbor disease stage; 5. ECOG performance status 0-1; 6. Patients without bone marrow involvement. The absolute number of neutrophile is no less then 2.0 \* 10\^9/L, platelet no less then 100 \* 10\^9/L. And the concentration of hemoglobin is no less than 110 g/L; 7. Life expectancy is no less than 6 months; 8. Patients who have signed the Informed Consent Form. Exclusion Criteria: 1. Patients who have central nervous system or meninges involvements; 2. Patients have been treated by radiotherapy, chemotherapy or immunotherapy for PTCL; 3. Patients have uncontrollable or significant cardiovascular disease including: * history of myocardial infarction; * uncontrollable angina within the 6 months before screening, or taking anti-angina drugs at the time of screening; * history of congestive heart failure, or the left ventricular ejection fraction (LVEF) is \< 50% at the time of screening; * clinically significant ventricular arrhythmia such as ventricular tachycardia, ventricular fibrillation or torsades de pointes; * History of supraventricular arrhythmia or nodal arrhythmia that could not been controlled by drug or need a pacemaker; * History of cardiomyopathy; * History of clinically significant QTc interval prolongation, or QTc interval \> 450 ms at screening; * Coronary disease which is with symptoms and needs drug therapy; 4. Patients have undergone organ transplantation; 5. Patients with thromboembolic disease, hematencephalon or cerebral infraction within 4 weeks before screening, or patients who are under anticoagulant therapy; 6. Patients with clinically significant abnormalities in gastrointestinal tract, such as dysphagia, chronic diarrhea and intestinal obstruction which may affect the uptake,transformation and absorption of the drug; 7. Patients with active infections, including active bacterial,viral,fungoid, mycobacterium, parasite infections (but not including hyponychium fungoid infection), or infections which need not be treated by intravenous antibody therapies, or antiviral therapies, or any serious infection need to be treated by hospitalization; 8. Patients who have been conducted the surgery on a major organ in less than 6 weeks; 9. Hepatic function: Serum total bilirubin \> 1.5 fold of normal range; ALT/AST \> 2.5 folds of normal range or 5 folds for liver metastasis; Renal function: Serum creatine \> 1.5 folds of normal range; 10. Patients with other malignancies in the past or now (except basal cell carcinoma, squamous-cell carcinoma or carcinoma in situs of cervix that has been adequately treated),unless the malignancy has been radically treated and there has been no evidence of recurrence for 5 years; 11. Pregnant or lactating women and patients in childbearing age who will not carry out birth control; 12. Patients with mental disorders, which may affect understanding and execution of informed consent or the compliance of the study; 13. Drug abuse or long term alcoholism that could affect the evaluation for the study results; 14. Patients considered by investigators not suitable for the study.

Study Objectives Evaluation of maintenance BCG immunotherapy (dose 27 mg) in superficial bladder tumors. Two randomized arms (every 3 or 6 months) will be studied for a population of 300 patients. Conditions: Bladder Cancer Intervention / Treatment: BIOLOGICAL: bladder tumor recurrence Location: France Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Ta and T1 bladder tumors Exclusion Criteria: * BCG contra-indications

Study Objectives The purpose of this study is to assess in a prospective multicentric study (Phase III) the introduction of a monoclonal antibody directed against B-cells associated with a standard therapy including chemotherapy and alpha-interferon in first line treatment of patients with a large tumor burden follicular lymphoma. Conditions: Lymphoma Intervention / Treatment: DRUG: rituximab Location: France, Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed follicular lymphoma with a biopsy performed in the last 3 months * Patients previously untreated. * Patients with at least one of the following symptoms requiring initiation of treatment: * Bulky disease at study entry according to the Groupe d'Etudes Lymphomes Folliculare (GELF) criteria: nodal or extranodal mass \> 7cm in its greater diameter * B symptoms * Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 1 * Elevated serum lactate dehydrogenase (LDH) or beta2-microglobulin * Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm) * Symptomatic splenic enlargement * Compressive syndrome * Pleural/peritoneal effusion * Age must be \> 18 years and less than 76 years * Having previously signed a written informed consent form. Exclusion Criteria: * Transformation to high-grade lymphoma (secondary to "low-grade" follicular lymphoma). * Patients without a large tumor burden. * Patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer. * Poor renal function: Serum creatinine \> 150 μmol/L, * Known HIV infection or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. * Patients with contra-indication to interferon, adriamycin, or rituximab. * Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). Judgment is up to the investigator. * Known sensitivity or allergy to murine products * Adult patient under tutelage.

Study Objectives The research aims to the primary hepatic carcinoma patients whose diameter of the single tumor is equal or less than 5cm.By supervising the changes of liver function, Child-Pugh score, ICG-R15 value, secondary reaction, incidence rate of RILD during and after the radiotherapy, meanwhile combining the outcome of the progression of disease and the condition of survival quality, the optimum proposal could be obtained and apply to clinic thus make the treatment safe, effective and personalized. Conditions: CyberKnife Radiosurgery Intervention / Treatment: RADIATION: Dose fraction forms Location: China Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * The participants are from 30 to 80 years of age, without gender restriction * With the hepatopathy background, the diagnosis of primary hepatic carcinoma is confirmed by image examination and laboratory test(the diagnosis criteria is according to the primary hepatic carcinoma rule of diagnosis and treat in 2007) * The max diameter of single tumor ≤5cm * Child-Pugh Classification(CPC) A or B * ECOG score 0 or 1 * Leukocyte is more than 2×109/L and thrombocyte is more than 60×109/L * Kidney function is normal * Unsuitable or rejecting other therapies such as resection, liver transplantation etc * Anticipated lifetime is longer than six months * The participants who are voluntary comply with the requirements of research * The participants agree to sign the informed consent. Exclusion Criteria: * The metastasis occur outside of liver * Child-Pugh Classification(CPC) * The outline of tumor is not confirmed by image examination * With hepatic or any other abdomen radiotherapy history before * With severe internal medicine diseases * Bone marrow haematopoietic function or kidney function is severe failure * Intractable ascites * The position of tumor is nearby esophagus, stomach or intestine * The normal liver volume less than 700 cm3

Study Objectives RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with cytarabine in treating patients who have refractory or recurrent acute myeloid leukemia or chronic myelogenous leukemia. Conditions: Leukemia Intervention / Treatment: DRUG: cytarabine, DRUG: irinotecan hydrochloride Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: * Histologically confirmed acute myeloid leukemia (M0-M7) * De novo or secondary disease * Previously treated and refractory to prior therapy (which has included high-dose cytarabine and an anthracycline) * Antecedent hematologic disorders allowed OR * Histologically confirmed Philadelphia chromosome-positive chronic myelogenous leukemia in myeloid blast transformation * Treated or untreated * Blast transformation defined by at least 20% blasts in marrow and/or blood * Myeloid lineage defined by immunophenotyping PATIENT CHARACTERISTICS: Age * 15 and over Performance status * 0-3 Life expectancy * At least 4 weeks Hematopoietic * See Disease Characteristics Hepatic * Bilirubin less than 2 times upper limit of normal (ULN) * SGOT less than 2 times ULN Renal * Creatinine less than 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * No other concurrent serious medical or psychiatric illness that would preclude study consent PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * Prior chemotherapy for an antecedent malignancy or other medical condition allowed Endocrine therapy * Not specified Radiotherapy * Prior radiotherapy for an antecedent malignancy or other medical condition allowed Surgery * Not specified

Study Objectives This research study is studying a combination of drugs as a possible treatment for triple-negative breast cancer that has spread to other areas of the body. The names of the study interventions involved in this study are: * Cisplatin * AZD1775 Conditions: Triple-negative Metastatic Breast Cancer Intervention / Treatment: DRUG: Cisplatin, DRUG: AZD1775 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: * Participants must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease. Patients without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation. * Either the primary invasive tumor and/or the metastasis must be triple-negative, defined as: * hormone-receptor poor, ER- and PR-negative, or staining present in \<1% by immunohistochemistry (IHC) * HER2-negative: 0 or 1+ by IHC, or FISH\<2.0 * Participants must have at least one lesion that is not within a previously radiated field that is measurable on computerized tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST version 1.1. Bone lesions are not considered measurable by definition. See Section 11 for the evaluation of measurable disease. * Prior chemotherapy: Patients may have received 0-1 prior chemotherapeutic regimen for metastatic breast cancer and must have been off treatment with chemotherapy for at least 21 days before enrollment in the study. The number of patients with 0 prior chemotherapeutic regimen will be limited to a maximum of n = 20. * Prior biologic therapy: Patients must have discontinued all biologic therapy at least 21 days before participation. * Prior radiation therapy: Patients may have received prior radiation therapy in either the metastatic or early-stage setting. Radiation therapy must be completed at least 14 days prior to study participation and patients should have recovered from adverse effects of radiation to grade ≤1. * Age ≥18 * ECOG performance status ≤1 * Participants must have normal organ and marrow function as defined below: * Absolute neutrophil count ≥ 1500/mm3 * Platelets ≥100,000/mm3 * Hemoglobin ≥ 9 g/dL * Total Bilirubin ≤ 1.5 mg/dL * Serum creatinine ≤1.5 mg/dL OR measured creatinine clearance (CrCl) ≥45 mL/min as calculated by the Cockcroft-Gault method OR 24-hour measured urine CrCl ≥45mL/min * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal. For patients with documented liver metastases, AST/ALT ≤ 5.0 times the upper limit of normal. * Patients on bisphosphonates may continue receiving bisphosphonate therapy during study treatment. * Availability of a tissue block from initial breast cancer diagnosis and/or metastatic recurrence. If a tissue block is not available, 10-20 unstained slides may be provided as an alternative. If unstained slides will be provided, they should not be sent until specifically requested by the DFCI study coordinator. If archival tumor tissue is not available, a fresh biopsy may be performed. * In the first stage of the trial, at least 10 patients with biopsy-accessible disease must be willing to undergo paired research biopsies. These biopsies will occur 5-48 hours after the C1D1 cisplatin dose (ie. C1D2or C1D3) and 5-8hrs (+/- 24hrs) after the last dose of AZD1775 on C2D3. The exact timing of the biopsy relative to receipt of study treatment should be accurately recorded. * Biopsies may be done with local anesthesia or intravenous conscious sedation, according to standard institutional guidelines. * Research biopsies requiring general anesthesia are not allowed on this protocol unless a biopsy is being obtained simultaneously for clinical reasons, in the judgment of the patients' treating physician. * Patients who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to continue protocol therapy. They will not be required to undergo a repeat biopsy attempt. * If dosing is delayed placing the biopsy outside of the allowable window, the biopsy should be rescheduled to be within the window. If not feasible, the biopsy should be obtained as close to within the window as possible. * Fine needle aspirates (FNA) is not allowed * Female subjects of childbearing potential must have a negative serum pregnancy test at screening. * The effects of AZD1775 on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use enhanced methods of contraception. All women are considered to be of childbearing potential unless they fulfill one of the following criteria at screening: * Post-menopausal defined as age ≥50 and amenorrheic for at least 12 months OR Women age \<50 if they have been amenorrheic for at least 12 months and have a serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) level in the postmenopausal range (per institutional standards). * If women have documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, or bilateral tubal ligation, they are considered post-menopausal. * Appropriate contraception should be used from the time of screening, throughout the duration of study participation, and for four months after the last dose of AZD1775. Acceptable methods of contraception include abstinence, tubal ligation, intra-uterine devices, and vasectomised partner. All methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by the male sexual partner for intercourse. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the participants treating physician should be informed immediately. Additionally, male patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing AZD1775. If male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of study treatment. * Participant must be able to swallow pills. * Participant may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN). * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Participants who are receiving any other investigational agents within 21 days of the first dose of study drug. * Major surgical procedures \<28 days from beginning study treatment. * Participants who have received a prior inhibitor of Wee1 kinase activity * Participants who have received prior platinum chemotherapy * Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms. Patients with a history of treated central nervous system (CNS) metastases are eligible. Treated brain metastases are defined as those having no evidence of progression for ≥ 1 month after treatment, or hemorrhage for ≥ 2 weeks after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or CT scan) during the screening period. Any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for ≥2 weeks before the first study drug. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 1 month before day 1 of study treatment will be excluded. * Patients with grade \>1 neuropathy or grade \>1 toxicity (except alopecia or anorexia) from prior therapy * History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD1775 or Cisplatin. * Participants receiving any medications, substances, or foods (ie, grapefruit juice) listed below are ineligible (Please refer to Section 5.4 for list of restricted co-medications): * prescription or non-prescription drugs or other products known to be sensitive CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued 2 weeks prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug. sensitive substrates of CYP2C8, CYP2C9, CYP2C19, or substrates of these enzymes with narrow therapeutic range * inhibitors or substrates of P-gp * Participants who have an uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure-New York Heart Association Class III or IV (Appendix B), active ischemic heart disease, myocardial infarction within the previous six months, uncontrolled diabetes mellitus, gastric or duodenal ulceration diagnosed within the previous 6 months, chronic liver or renal disease, or severe malnutrition. In addition, patients are ineligible if they have a psychiatric illness or a social situation that could limit their ability to comply with the study requirements. * Participants who have refractory nausea and vomiting, chronic gastrointestinal diseases, or previous significant bowel resection that would preclude adequate absorption of AZD1775. * Pregnant women are excluded from this study because AZD1775 is a Wee1 inhibitor agent with the potential for teratogenic or abortifacient effects. * Lactating or breastfeeding women are excluded because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD1775, breastfeeding should be discontinued prior to being treated with AZD1775. These potential risks may also apply to other agents used in this study. * Known HIV-positive participants are ineligible because these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. * Participant with mean resting corrected QT interval (specifically QTc calculated using the Fridericia formula \[QTcF\]) \> 450 msec for males and \> 470 msec for females, from 3 electrocardiograms (ECGs) performed within 2-5 minutes apart at study entry, or congenital long QT syndrome.

Study Objectives This is a phase II intervention to propose a new melanoma chemoprevention agent. The investigators believe oxidative stress/damage in nevi is a probable indication for melanoma risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate whether administration of NAC around the time of UV exposure will reduce melanoma risk in high-risk patient populations with genetic susceptibility to UV-induced oxidative stress, and 2) examine key genetic variants that will identify which individuals are most likely to benefit from chemoprotection. Conditions: Patients at Risk for Melanoma Intervention / Treatment: DRUG: N-acetylcysteine, OTHER: Placebo arm Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Inclusion Criteria: * Must have at least 2 nevi (each \>6 mm diameter) not clinically suspicious for melanoma that can be biopsied. * Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria: * The patient is a minor (\< 18 years old). * The patient cannot speak/understand English or Spanish. (NOTE: A Spanish consent form and certified interpreter can be made available if needed) * The patient is pregnant. (NOTE: All female patients who have not had a hysterectomy and are not post-menopausal (i.e. post-menopausal for 1 year and not of child-bearing potential) will have a urine pregnancy test.) * The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable. * The patient has history of allergic reaction to NAC. * The patient has history of severe asthma. * The patient has been taking NAC or any other oral antioxidant. * The patient has recent history (i.e., 3 months) of sunless tanning (tanning bed) or extensive sunburn.

Study Objectives The goal of this study is to examine the effects of an enhanced caregiver training protocol that not only teaches informal caregivers knowledge and skills for managing patient symptoms, but also provides strategies for managing their own psychological distress. The investigators anticipate this training will increase caregivers' self-efficacy and improve important caregiver outcomes (depression, anxiety, burden, quality of life) and patient outcomes (symptom distress/intensity, depression, anxiety, and quality of life). The study will compare the effects of this protocol to an education control condition that equates for interventionist time and attention. Conditions: Neoplasms Intervention / Treatment: OTHER: Self-Efficacy Training for Caregivers, OTHER: Comparison Conditions for Caregivers Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: HEALTH_SERVICES_RESEARCH Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria (patients): * Diagnosis of cancer (liquid or solid tumor); * Admitted to DUMC's 9100 or 9300 for cancer treatment or related complications; * 18 years of age or older; * Able to read, speak and write in English; * Anticipates being discharged to home; * Not referred to hospice; * Will have home care needs after discharge; * No major cognitive impairment; * Has caregiver willing to do study training and surveys. Inclusion Criteria (caregivers): * 18 years of age or older; * Able to read, speak and write in English; * Interacts with, and provides most of the hands-on care to, patient who meets above criteria.

Study Objectives RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Hydroxychloroquine may help chemotherapy and bevacizumab work better and kill more tumor cells. PURPOSE: This phase II trial is studying how well giving hydroxychloroquine together with capecitabine, oxaliplatin, and bevacizumab works in treating patients with metastatic colorectal cancer. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: hydroxychloroquine Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed colorectal carcinoma * Metastatic disease * Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as \> 20 mm by conventional techniques or \> 10 mm by spiral CT scan * Brain metastases allowed provided they have been treated and stable for \> 4 weeks PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * AST/ALT ≤ 3 times upper limit of normal (ULN) * Total bilirubin ≤ 1.5 times ULN * PT (INR) ≤ 1.5 * Creatinine \< 1.5 times ULN * Creatinine clearance ≥ 30 mL/min * Urine protein:creatinine ratio \< 1.0 OR \< 1 g protein by 24-hour urine collection * Not on dialysis * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception before, during, and for 4 weeks after completion of study treatment * Prior non-colonic malignancies allowed provided there is no current clinical evidence of persistent or recurrent disease AND the patient is not on active therapy, including hormonal therapy * No uncontrolled hypertension, defined as systolic BP \> 150 mm Hg or diastolic BP \> 90 mm Hg, despite antihypertensive medications * No cardiac disease, including any of the following: * NYHA class III-IV congestive heart failure * Unstable angina (anginal symptoms at rest) * New onset angina (began within the past 3 months) * Myocardial infarction within the past 6 months * Uncontrolled arrhythmia * No thrombolic or embolic events (e.g., cerebrovascular accident including transient ischemic attacks) within the past 6 months * No serious non-healing wound, ulcer, or bone fracture * No significant traumatic injury within the past 28 days * No neuropathy ≥ grade 2 * No evidence of bleeding diathesis or coagulopathy * No condition that would impair the patient's ability to swallow whole pills * No malabsorption problem * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * No known G-6PD deficiency * No retinal or visual field changes from prior 4-aminoquinoline compound use * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine or hydroxychloroquine * No other concurrent serious systemic disorders (including active infections) that, in the investigator's opinion, would compromise the safety of the patient or compromise the patient's ability to complete the study PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy for metastatic disease, except for adjuvant therapy that was completed ≥ 6 months before the first evidence of metastasis * More than 28 days since prior major surgical procedure or open biopsy * No concurrent anticoagulation with warfarin * Concurrent low molecular weight heparin (or an equivalent drug) allowed * No concurrent hydroxychloroquine for treatment or prophylaxis of malaria * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent St. John wort * No other concurrent investigational or anticancer agents or therapies

Study Objectives To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone Conditions: Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer Intervention / Treatment: DRUG: MM-121, DRUG: Paclitaxel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer * Received at least one prior platinum based chemotherapy regimen * Platinum-resistant or refractory * Eligible for weekly paclitaxel * Adequate liver and kidney function * 18 years of age or above Exclusion Criteria: * Evidence of any other active malignancy * History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor®EL

Study Objectives This is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide vaccination in patients with metastatic melanoma. The objective of this study is to determine the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a multi-epitope melanoma peptide vaccine (tyrosinase and gp100 peptides) in patients with AJCC stage IIB, IIC, III and IV melanoma who are HLA-A2+. We will assess whether use of GM-CSF DNA is safe and generates an immune response to peptides derived from antigens on melanoma cells. Conditions: Melanoma Intervention / Treatment: BIOLOGICAL: GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients must have documented malignant melanoma, American Joint Commission on Cancer (AJCC) stage IIB, IIC, III or IV (54). Patients with resectable stage IIB, IIC and III disease must have undergone surgical resection before participating in this study. * Patients with choroidal melanoma may participate if they fulfill one of the following criteria: Basal diameter \> or = 16 mm; Height \> or = 8 mm or involvement of ciliary body with tumor. * For all patients, pathology slides must be reviewed by the Pathology Department of Memorial Sloan-Kettering Cancer Center for confirmation of melanoma diagnosis. * Patients must be HLA-A2 positive. * Patients must weigh at least 25 kg to be eligible. Patients must be able to read the consent form and give informed consent. Parent or legal guardians of patients who are minors will sign the informed consent form. * Patients must have a Karnofsky performance status of at least 80. * LDH ≤ 2x upper limit of normal value; albumin ≥ 3.5 mg/dl. Creatinine ≤ 2mg/dl and AST ≤ 2- fold upper limit of normal. * A CBC prior to vaccination with WBC ≥ 3000, platelets ≥ 100,000. * A negative serum bHCG within 2 weeks of vaccination in women of childbearing age. * Patients must be free of detectable brain metastases. (Brain MRI or CT pre-protocol) Exclusion Criteria: * Patients may not be receiving or have received chemotherapy, immunotherapy or radiation therapy within the previous 4 weeks or nitrosourea chemotherapy within the previous 6 weeks. Patients must be fully recovered from any previous therapy or surgery. * Patients may not have been previously immunized with vaccines containing tyrosinase or gp100, or peptides derived from tyrosinase or gp100. * Creatinine \> 2mg/dl (or history of Creatinine \> 2 mg/dl) and AST ≥ 2 fold upper limit of normal. * Any medical condition or use of medication (e.g., active autoimmune disease, immunodeficiency or corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators. Patients may not have taken systemic corticosteroids (orally or intravenously) within the previous 6 weeks. Inhaled or nasal steroids are permitted. * Patients who have preexisting retinal or choroidal eye disease (except as outlined in section 5.1.1) will be excluded. * Patients with serious underlying medical conditions, active infections requiring antimicrobial drugs, or active bleeding will be ineligible. * Pregnant women, women who are less than 3 months post-partum or women who are nursing are not eligible. Women of childbearing age and sexually active men must be using appropriate contraception during the course of this study and for 3 months following completion.

Study Objectives Phase I trial to study the effectiveness of erlotinib in treating patients who have metastatic or unresectable solid tumors and liver or kidney dysfunction. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor Conditions: Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma, Adult Diffuse Astrocytoma, Adult Ependymoblastoma, Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Adult Mixed Glioma, Adult Myxopapillary Ependymoma, Adult Oligodendroglioma, Adult Pilocytic Astrocytoma, Adult Primary Hepatocellular Carcinoma, Adult Subependymoma, Advanced Adult Primary Liver Cancer, Advanced Malignant Mesothelioma, Male Breast Cancer, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Adult Brain Tumor, Recurrent Adult Primary Liver Cancer, Recurrent Anal Cancer, Recurrent Basal Cell Carcinoma of the Lip, Recurrent Bladder Cancer, Recurrent Breast Cancer, Recurrent Cervical Cancer, Recurrent Colon Cancer, Recurrent Esophageal Cancer, Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Recurrent Lymphoepithelioma of the Nasopharynx, Recurrent Lymphoepithelioma of the Oropharynx, Recurrent Malignant Mesothelioma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Non-small Cell Lung Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Pancreatic Cancer, Recurrent Prostate Cancer, Recurrent Rectal Cancer, Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Stage II Esophageal Cancer, Stage II Pancreatic Cancer, Stage III Esophageal Cancer, Stage III Pancreatic Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Adenoid Cystic Carcinoma of the Oral Cavity, Stage IV Anal Cancer, Stage IV Basal Cell Carcinoma of the Lip, Stage IV Bladder Cancer, Stage IV Breast Cancer, Stage IV Colon Cancer, Stage IV Esophageal Cancer, Stage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity, Stage IV Inverted Papilloma of the Paranasal Sinus and Nasal Cavity, Stage IV Lymphoepithelioma of the Nasopharynx, Stage IV Lymphoepithelioma of the Oropharynx, Stage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity, Stage IV Mucoepidermoid Carcinoma of the Oral Cavity, Stage IV Non-small Cell Lung Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Pancreatic Cancer, Stage IV Prostate Cancer, Stage IV Rectal Cancer, Stage IV Salivary Gland Cancer, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Verrucous Carcinoma of the Larynx, Stage IV Verrucous Carcinoma of the Oral Cavity, Stage IVA Cervical Cancer, Stage IVB Cervical Cancer, Unspecified Adult Solid Tumor, Protocol Specific, Untreated Metastatic Squamous Neck Cancer With Occult Primary Intervention / Treatment: DRUG: erlotinib hydrochloride, OTHER: laboratory biomarker analysis Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed solid tumor, including gliomas and the following epithelial malignancies: * Non-small cell lung * Mesothelioma * Breast * Head and neck * Esophageal * Pancreatic * Bladder * Prostate * Ovarian * Anal * Colorectal carcinoma * Cervical carcinoma * Hepatocellular carcinoma * Metastatic or unresectable disease * Standard curative or palliative therapy does not exist or is no longer effective * Epidermal growth factor receptor (EGFR) positive * Hepatic or renal dysfunction defined as one of the following: * Direct bilirubin 1.0-7.0 mg/dL with any AST * Albumin less than 2.5 g/dL * Creatinine 2.5-5.0 mg/dL * Brain metastases allowed provided patient is asymptomatic, previously treated, has stable disease for at least 2 months, and is not currently receiving steroid therapy * Hormone receptor status: * Not specified * Male or female * Performance status - ECOG 0-2 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * See Disease Characteristics * No evidence of biliary obstruction * See Disease Characteristics * No evidence of renal obstruction * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No gastrointestinal tract disease that would preclude ability to take oral medications * No requirement for IV alimentation * No active peptic ulcer disease * No prior corneal abnormalities (e.g., dry eye syndrome or Sjogren's syndrome) * No prior congenital abnormality (e.g., Fuch's dystrophy) * No prior abnormal slit-lamp exam using a vital dye (e.g., fluorescein or Bengal-Rose) * No prior abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) * No other concurrent uncontrolled illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * Not pregnant or nursing * Fertile patients must use effective contraception * No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) * At least 4 weeks since prior chemotherapy (6 weeks for melphalan or mitomycin) * No prior nitrosoureas * See Disease Characteristics * No concurrent steroids * At least 4 weeks since prior radiotherapy * At least 4 weeks since prior major surgery * No prior surgical procedures affecting absorption * No prior EGFR-targeting therapies, including gefitinib or Imclone C-225 * At least 3 months since prior suramin * More than 7 days since prior grapefruit juice * More than 7 days since other prior CYP3A4 inhibitors * No concurrent grapefruit juice * No concurrent CYP3A4 inducers, substrates, or other inhibitors * No concurrent medications known to affect hepatic or renal function, including antiseizure medication or nonsteroidal anti-inflammatory agents * No concurrent combination anti-retroviral therapy for HIV-positive patients

Study Objectives The purpose of this study is to develop and test a 6 month manualized Health Education intervention in recent breast cancer survivors. Conditions: Breast Cancer Intervention / Treatment: BEHAVIORAL: Individualized Manualized Health Education Intervention Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy) * Having received chemotherapy as part of their primary therapy for breast cancer * Be in complete remission * Aged 18 years or older * Able to read, write, and understand English * Karnofsky Performance Status (KPS) greater than or equal to 60 * Have impaired quality of life * Ability to give informed consent Exclusion Criteria: * Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed therapy is not exclusionary. * Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary. * Patients on adjuvant hormone therapy for less than 2 months * Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.

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

Inclusion Criteria: 1. Sign written informed consent before any trial-related processes are implemented; 2. Age ≥ 18 years old and ≤ 75 years old; 3. Life expectancy exceeds 3 months; 4. The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if it is confirmed to have progressed; 5. Patients with treated metastatic or recurrent (stage IV) NSCLC confirmed by histology or cytology according to the International Association for the Study of Lung Cancer and the American Association for the Classification of Cancer Classification, 8th edition; 6. The Eastern Cancer Cooperative Group (ECOG) has a fitness status score of 0 or 1; 7. Patients with genetic testing (allowing PCR and NGS detection methods) confirmed uncommon mutations (EGFR G719X, L861Q, S768I, and 20ins et al.), patients can accept two or more types of EGFR rare co-mutation. Populations with the primary EGFR T790M mutation can also be included in the study. 8. Patients who have experienced disease progression after at least two treatment regimens for advanced/metastatic disease must include a platinum-containing systemic chemotherapy and an EGFR-TKI treatment. Patients with EGFR 20ins who have experienced disease progression only after platinum-containing systemic chemotherapy. 9. Hematological function is sufficient, defined as absolute neutrophil count ≥1.5×109 /L, platelet count ≥100 ×109 /L, hemoglobin ≥90g/L (no history of blood transfusion within 7 days); 10. Hepatic function is adequate, defined as all patients with total bilirubin levels ≤ 1.5 times normal upper limit (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN, or for patients with liver metastases , AST and ALT levels ≤ 5 times ULN; 11. adequate renal function, defined as creatinine clearance ≥ 45 ml/min (Cockcroft-Gault formula); 12. Coagulation function is adequate, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulant therapy, as long as the INR or PT is within the range of anticoagulant drugs can; 13. Female subjects of childbearing age should be negative for urine or serum pregnancy test within 3 days prior to receiving the first study drug. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required; 14. If there is a risk of conception, male and female patients need to use high-efficiency contraception (ie, an annual failure rate of less than 1%) and continue until at least 180 days after stopping the trial treatment; Note: If abstinence is normal for the subject Lifestyle and preferred methods of contraception can be used as a method of contraception. Exclusion Criteria: 1. Histology is NSCLC, if there are small cell carcinoma, neuroendocrine carcinoma, sarcoma components, it can not be included; 2. Patients with known EGFR-sensitive mutations (19-Del and L858R); 3. Cavity lung squamous cell carcinoma, or non-small cell lung cancer patients with hemoptysis (\>50 mL/day); 4. Patients whose tumor has invaded an important blood vessel or who is judged by the investigator to have major bleeding during the follow-up study; 5. Patients with any signs or history of bleeding physique; 6. Currently participating in interventional clinical research treatment, or receiving other research drugs or research equipment within 4 weeks prior to the first dose; 7. Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or against another stimulus or synergistic inhibition of T cell receptors (eg CTLA-4, OX-40, CD137) drug; 8. Received a proprietary Chinese medicine or immunomodulatory drug (thymosin, interferon, interleukin, etc.) with anti-cancer indications within 2 weeks before the first dose, or received major surgery within 3 weeks before the first dose; 9. Received a physical organ or blood system transplant; 10. There is clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not need drainage or stop drainage and have no significant increase in 3 days of effusion can be enrolled); 11. The tumor compresses important organs (such as the esophagus) around it and is accompanied by related symptoms, oppression of the superior vena cava or invasion of the mediastinal vessels, heart, etc.; 12. Class III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias; 13. Any arterial thrombosis, embolism or ischemia occurred within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack. A history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to enrollment (implanted IV port or catheter-derived thrombosis, or superficial vein thrombosis is not considered a "serious" thrombosis embolism); 14. It is known that there is an allergic reaction to the active ingredient of sindril mAb and or any excipients; 15. Active autoimmune diseases requiring systemic treatment (eg, using disease-modifying drugs, corticosteroids or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (such as thyroxine, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments; 16. Patients who require long-term systemic use of corticosteroids. Patients with intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroids due to COPD or asthma may be enrolled. 17. has not fully recovered from toxicity and/or complications caused by any intervention prior to initiation of treatment (ie, ≤1 or baseline, excluding fatigue or alopecia); 18. diagnosis within 5 years prior to initial dosing For other malignancies, it does not include radical cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ. If more than 5 years before the drug is diagnosed as other malignant tumors or lung cancer, pathological or cytological diagnosis of recurrent metastatic lesions is required; 19. symptomatic central nervous system metastasis. For patients with asymptomatic brain metastases or brain metastases with stable symptoms after treatment, as long as all the following criteria are met, participate in this study: measurable lesions outside the central nervous system; no midbrain, pons, cerebellum, meninges, Medulla or spinal cord metastasis; maintain clinical stability for at least 2 weeks; stop hormone therapy 14 days before the first study drug; 20. One year before the first dose, a history of non-infectious pneumonia requiring corticosteroid treatment or the presence of non-infectious pneumonia; 21. active infections requiring treatment or systemic anti-infectives used within one week prior to first administration; 22. There are known cases of mental illness or substance abuse that may have an impact on compliance with the test requirements; 23. A history of human immunodeficiency virus (HIV) infection (ie, HIV 1/2 antibody positive), known syphilis infection (positive syphilis antibody), and active tuberculosis are known. 24. Untreated active hepatitis B; Note: Hepatitis B subjects meeting the following criteria are also eligible for inclusion: The HBV viral load must be \<1000 copies/ml (200 IU/ml) or below the lower limit of detection before the first dose. Subjects should receive anti-HBV treatment during the entire study chemotherapy drug treatment to avoid viral reactivation. For subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but viral reactivation is closely monitored; 25. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection); 26. Vaccination with live vaccine within 30 days prior to first dose; Note: Injectable inactivated virus vaccine for seasonal influenza is permitted; however, live attenuated influenza vaccine for intranasal administration is not permitted; 27. There are medical history, disease, treatment, or laboratory abnormalities that may interfere with the test results, hinder the subject's full participation in the study, or the investigator believes that participating in the study is not in the best interest of the subject. 28. Local or systemic diseases caused by non-malignant tumors, or secondary reactions to cancer, and may lead to higher medical risks and/or uncertainty in survival assessment.

Study Objectives This study is being done to study the healthful benefits of eating garlic. Previous studies suggest that garlic may help prevent cancer. The investigators are recruiting healthy volunteers to participate in a study to determine the ways in which eating garlic may reduce cancer risk. Conditions: Healthy Men, Healthy Women Intervention / Treatment: OTHER: Control, OTHER: Garlic treatment Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: DOUBLE

Inclusion Criteria: * Age 40-80 years Exclusion Criteria: * Younger than 40 years old or older than 80 years old * Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisinidione) * Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases or malabsorption syndromes. * Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study * Follicle stimulating hormone levels above 35 mIU/mL serum * Type 2 diabetes requiring the use of oral antidiabetic agents or insulin * History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets) * Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity * Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months). * Use of any tobacco products in past 6 months * Use of oral or IV antibiotics during the month preceding the study or during the study * Unwillingness to abstain from vitamin, mineral, and herbal supplements for two weeks prior to the study and during the study * Known (self-reported) allergy or adverse reaction to garlic * Inability to metabolize garlic * Unable or unwilling to give informed consent or communicate with study staff * Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion) * Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Study Objectives Background: - Irinotecan is a drug that is used to treat colon or rectal cancer. It affects the deoxyribonucleic acid (DNA) of growing cancer cells. It is most often used with other chemotherapy drugs. Researchers want to test it with an experimental drug, ISIS 183750. They want to see if the drugs are a safe and effective treatment for advanced solid tumors or colorectal cancer that has not responded to other treatments. Objectives: - To test the safety and effectiveness of ISIS 183750 with irinotecan for advanced solid tumors or colorectal cancer. Eligibility: - Individuals at least 18 years of age who have solid tumors or colorectal cancer that has not responded to other treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. Tumor tissue samples may be collected as well before and after treatment. Imaging studies will also be performed. * Participants will take ISIS 183750 once a week for 28-day cycles of treatment. On the first cycle, they will also have ISIS 183750 on days 3 and 5. * Participants will take irinotecan every second week, beginning on day 15 of the first cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Treatment will continue as long as the cancer does not grow and the side effects are not severe. Conditions: Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Tumors Intervention / Treatment: DRUG: ISIS 183750, DRUG: Irinotecan Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

* INCLUSION CRITERIA: * Phase I: Patients must have histopathological confirmation of carcinoma by the Laboratory of Pathology of the National Cancer Institute (NCI) prior to entering this study. * Phase II: Patients must have histopathological confirmation of Colorectal Carcinoma (CRC) by the Laboratory of Pathology of the NCI prior to entering this study. For this portion of the study patients must also have irinotecan-refractory colorectal cancer and have also received prior treatment for advanced/metastatic disease with an oxaliplatin-, bevacizumab-, or epidermal growth factor receptor (EGFR) inhibitor-containing (only for subjects with wild type Kras) regimen. Irinotecan-refractory will be defined as patients who have radiological evidence of disease progression whilst receiving irinotecan or within 3 months after completing it. * Patients must have disease that is not amenable to potentially curative resection or ablative techniques and have received at least one prior standard chemotherapeutic regimen for metastatic disease. * All patients enrolled will be required to have measurable disease. For the phase II portion of the study patients must have disease that is amenable to biopsy and be willing to undergo this. * Age greater than18 years * Life expectancy of greater than 3 months * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patients must have acceptable organ and marrow function as defined below: * leukocytes \> 3,000/mcL * absolute neutrophil count \> 1,500/mcL * platelets \> 100,000/mcL * total bilirubin Within normal institutional limits * Serum albumin greater than or equal to 2.5 g/dL * Patients are eligible with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) measuring 3 x upper limit of normal (ULN) if no liver metastasis or up to 5 x ULN with liver metastasis. * creatinine \< 1.5X institution upper limit of normal * OR * creatinine clearance \> 45 mL/min/1.73 m\^2, as calculated below, for patients with creatinine levels above institutional normal * Estimated creatinine clearance (mL/min) * Females see calculations * Males see calculations - May use a 24 hr. urine collection to determine creatinine clearance. * Measured creatinine clearance (mL/min) * Patients must have recovered from any acute toxicity related to prior therapy, including surgery. Toxicity should be \< grade 1 or returned to baseline. * Patients must not have other invasive malignancies within the past 3 years (with the exception of non-melanoma skin cancers, carcinoma in situ of the cervix and noninvasive bladder cancer that has had successful curative treatment). * The effects of ISIS 183750 on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months after dosing with study medication ceases. However, adequate contraception for male patients should be used for 16 weeks post- last dose due to sperm life cycle. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of child-bearing potential must have a negative pregnancy test prior to entry. * Patient must be able to understand and willing to sign a written informed consent document. * Men and women of all races and ethnic groups are eligible for this trial. * Ejection fraction \> 55% on echocardiogram. EXCLUSION CRITERIA: * Patients who have had chemotherapy (or so-called targeted systemic therapy), large field radiotherapy, or major surgery must wait 4 weeks after completing treatment prior to entering the study. * Patients may not be receiving any antineoplastics or other drugs intended to treat cancer within 4 weeks prior to starting ISIS 183750. * Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with clinically significant ascites, pleural effusion, and/or peripheral edema, unless the ascites or pleural effusion occurred as a result of malignancy. * Patients with known hypersensitivity to irinotecan. * Patients with known homozygous mutations in the UTG1A1 UUDP-glucuronosyltransferase 1-1) allele, or with unknown UTG1A1 status but who could not tolerate irinotecan even after dose reduction. * Patients with bleeding diathesis and subjects who are receiving anticoagulation treatment with International Normalized Ratio (INR) \> 2.5 are excluded. * Uncontrolled intercurrent illness including, but not limited to, hypertension (systolic blood pressure (BP) \> 160, diastolic BP \> 100), ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements. * Human immunodeficiency virus (HIV)-positive patients receiving anti-retroviral therapy are excluded from this study due to the possibility of pharmacokinetic interactions between antiretroviral medications and the investigational agent. * Known hepatitis B or hepatitis C infection. * Pregnancy and breast feeding are exclusion factors. Enrolled patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation and 3 months after the end of the treatment.

Study Objectives The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety. Conditions: Breast Neoplasms Intervention / Treatment: DRUG: SU011248/Trastuzumab Location: Belgium, United States, Canada, Spain, France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease. * HER2 positive disease (3+ by immunohistochemistry \[IHC\] or FISH-positive) * Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted. Exclusion Criteria: * Prior treatment with \>1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted * Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions. * Prior treatment on a SU11248 clinical trial. * Uncontrolled brain metastases.

Study Objectives The purpose of this study is to assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (NET). Conditions: Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System Intervention / Treatment: DRUG: Pasireotide LAR followed by Pasireotide LAR + Everolimus, DRUG: Everolimus followed by Pasireotide LAR + Everolimus Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic neuroendocrine tumor * Progressive disease within last 12 months (only patients with nonfunctional tumors) * Documented liver metastasis * Measurable disease per RECIST determined by multiphase MRI or triphasic CT Exclusion Criteria: * Previous treatment with radiolabeled somatostatin analogs within 12 months prior to reporting baseline symptoms * Previous treatment with mTOR inhibitors or pasireotide * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study * Women who are pregnant or lactating Other protocol-defined inclusion/exclusion criteria may apply

Study Objectives The goal of this clinical research study is to evaluate the outcome of a standard radiation treatment called stereotactic radiotherapy (SRT) for NSCLC. Specifically, researchers want to learn if standard SRT has as good of an outcome at 3 years after the procedure. The safety of the study treatment will also be analyzed. Conditions: Lung Cancer Intervention / Treatment: RADIATION: Stereotactic Body Radiotherapy (SABR) 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. Histological confirmation of non-small cell cancer will be required by either biopsy or cytology. The following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma with or without BAC features, large cell carcinoma with or without neuroendocrine features, neuroendocrine carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified. 2. Eligible patients must have appropriate staging studies identifying them as specific subsets of the revised IASLC stage IA based on the following combination of TNM staging: T1a,N0,M0 or T1b,N0,M0 3. A PET/CT scan is required. Patients with hilar or mediastinal lymph nodes with short axis diameter \</= 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with \> 1 cm short axis diameter of hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. Solitary pulmonary lesions \</= 6mm will not be considered significant. 4. Patients must be considered a candidate for surgical resection of the primary tumor. Standard justification for deeming a patient medically operable based on pulmonary function for surgical resection of NSCLC may include any of the following: Baseline FEV1 \> 40% predicted, post-operative predicted FEV1 \> 30% predicted, diffusion capacity \> 40% predicted, absent baseline hypoxemia and/or hypercapnia, exercise oxygen consumption \> 50% predicted, absent severe pulmonary hypertension, absent severe cerebral, cardiac, or peripheral vascular disease, and absent severe chronic heart disease. 5. Patients must be \>/= 18 years of age. 6. The patient's Zubrod performance status must be Zubrod 0-2. 7. PET/CT scan to include both lungs, the mediastinum, and adrenal glands; Primary tumor dimension will be measured on diagnostic CT and again on simulation CT. Must be done within 10 weeks prior to study entry. 8. Mediastinoscopy or endobronchial ultrasound (EBUS) guided biopsy of mediastinal lymph nodes is required for all patients. Must be done within 10 weeks of study entry. 9. MRI or CT scans of Brain if there are symptoms or signs suggesting brain metastases, must be done within 10 weeks prior to study entry. 10. Invasive Mediastinal Staging - All patients with CT and/or PET evidence of hilar (level 10) or mediastinal lymph nodes \> 1.0 cm in the shortest diameter must be staged by either cervical mediastinoscopy, esophageal endoscopic ultrasound guided biopsy, or endobronchial ultrasound guided biopsy. 11. Patients must sign a study-specific consent form. 12. Patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study. Exclusion Criteria: 1. Patients with primary tumors \> 3 cm. 2. Patients with well-differentiated neuroendocrine carcinoma (carcinoid tumor). 3. Direct evidence of regional or distant metastases after appropriate staging studies, or synchronous primary or prior malignancy in the past 3 years other than nonmelanomatous skin cancer or in situ cancer. 4. Previous lung or mediastinal radiotherapy. 5. Plans for the patient to receive other concomitant local therapy (including standard fractionated radiotherapy and surgery) while on this protocol except at disease progression. 6. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus. 7. Cannot achieve acceptable SABR planning to meet minimal requirement of target coverage and dose-volume constraints of critical structures (see RT techniques).

Study Objectives The main purpose of this study is to see how well FDG-PET scans can determine the malignancy of thyroid nodules that have already been tested (and come back positive) by fine needle aspiration. Conditions: Thyroid Neoplasms Intervention / Treatment: OTHER: FDG-PET Scan Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: DIAGNOSTIC Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Documented history of a solitary thyroid nodule or a dominant nodule within multinodular disease, with fine needle aspiration demonstrating a follicular or indeterminate cytologic examination. If a core needle biopsy was performed instead of a fine needle aspiration, demonstrating follicular or indeterminate cytology, the patient is eligible if the biopsy procedure was felt to be minimally disruptive to the nodule architecture, based on a review by the PI or nuclear medicine investigator. * Thyroid nodule must be palpable on physical examination or have a minimum size of 1 cm in diameter by ultrasonography, CT or MRI. The minimum size criterion was established to address the spatial resolution limitations of PET/CT imaging. * Scheduled for surgical excision of thyroid nodules within 3 months of the date of the FDG-PET/CT scan. * Ability to tolerate lying supine for a FDG-PET/CT examination. * Age \>/= 18 and \</= 105 (This disease is rare in children and therefore the study will be limited to adults.) * Willing to participate in all aspects of the study (patient may opt out of the tissue collection portion.) * Patient must be euthyroid with a serum TSH or a free T4 level within the institutional upper and lower limits of normal, measured within 6 months of registration. NOTE: mild deviations from the institutional normal limits may be considered acceptable if the patient has achieved a clinically euthyroid state with medication at a stable dose for \>3 months, and the TSH is considered to be at target by the patient's treating physician. In patients with hyperthyroidism requiring treatment, this euthyroid state may be achieved with administration of a thionamide such as propylthiouracil prior to FDG-PET/CT exam. Patients with hyperthyroid inflammatory conditions such as thyroiditis and toxic multinodular goiter often exhibit increased glucose uptake resulting in diffuse uptake of FDG which may obscure visualization of a thyroid tumor. * If female, patient must have a negative pregnancy test at the time of registration, be post-menopausal (with no period in the last twelve months), have had a tubal ligation at least twelve months ago, or have had a hysterectomy. * In patients with multinodular disease and a dominant nodule, the nuclear medicine physician responsible for FDG-PET/CT scan interpretation must determine whether the indeterminate nodule can be discriminated on FDG-PET/CT imaging prior to enrollment. * A signed and dated written informed consent obtained from the patient or the patient's legally acceptable representative prior to study participation. Exclusion Criteria: * Patient has a fasting glucose level \> 200 mg/dL at the time of the PET/CT scan * Patient has had prior neck surgery or radiation that in the opinion of the investigator has disrupted tissue architecture of the thyroid * Patient has evidence of infection localized to the neck in the 14 days prior to the FDG-PET/CCT scan * Patient does not meet any of the inclusion criteria

Study Objectives Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. The purpose of this study is to determine whether Clofarabine is safe and effective in the treatment of Acute Lymphoblastic Leukemia (ALL.) Conditions: Leukemia, Lymphoblastic, Acute, Pediatric Intervention / Treatment: DRUG: clofarabine (IV formulation) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Have a diagnosis of ALL according to FAB classification with greater than or equal to 25% blasts in the bone marrow. * Be less than or equal to 21 years old at time of initial diagnosis. * Not be eligible for therapy of higher curative potential, and must be in second or subsequent relapse and/or refractory. Where an alternative therapy has been shown to prolong survival in an analogous population, this should be offered to the patient prior to discussing this study. * Have a Karnofsky Performance Status (KPS) of \>70. * Provide signed, written informed consent from parent or guardian and assent from patients greater than or equal to 7 years old according to local IRB and institutional requirements. * Be able to comply with study procedures and follow-up examinations. * Have adequate organ function as indicated by the following laboratory values, obtained within 2 weeks prior to registration: Serum bilirubin less than or equal to 1.5 x ULN; AST and ALT less than or equal to 5 x ULN; Serum Creatinine less than 2 x ULN for age. ULN= Institutional Upper Limit of Normal Exclusion Criteria: * Received previous treatment with Clofarabine. * Have had a recent (\<30 days) history of fungal or serious bacterial infection or who are receiving therapeutic antibiotics. * Are pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control (i.e., latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. * Have psychiatric disorders that would interfere with consent, study participation, or follow up. * Are receiving any other chemotherapy. Patients must have been off previous therapy for at least 2 weeks (with the exception of intrathecal therapy, which is allowed up to 24hrs prior to 1st of study drug) and must have recovered from acute toxicity of all previous therapy prior to enrollment. Treatment may start earlier, following consultation with the ILEX Medical Monitor, if there is evidence of disease relapse prior to that time. * Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or pancreas. * Have symptomatic CNS involvement. * Febrile neutropenia at time of study entry. * Have received a hematologic stem cell transplant (HSCT) within the previous 3 months or have active GVHD (greater than or equal to Grade 2).

Study Objectives Study Design: This is a pragmatic study on the management strategy for patients with metastatic colorectal cancer (CRC) who are candidates for CT, independently of any previous adjuvant therapy received. The aim of this study is to define the role of new target molecules in combination with CT in first- and second line treatment. First line study: Eligible patients were randomized to either treatment: Arm A: FOLFIRI or FOLFOX + Bevacizumab, cycle to be repeated every 2 weeks * BEVACIZUMAB: Day 1,1st cycle 5 mg/kg IV infusion of 90 min Day 1, 2nd cycle if well tolerated, 5 mg/kg IV infusion of 60 min Day 1, 3rd cycle and subsequent cycles if well tolerated, 5 mg/kg IV infusion of 30 min after 5-Fluorouracile (FU) bolus * FOLFIRI Day 1: Irinotecan 180 mg/m2 IV infusion 30-90 min Day 1,2: L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus 5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours - FOLFOX Day 1: Oxaliplatin 85 mg/m2 IV infusion of 2hours Day 1,2: L-Folinic acid 100 mg/m2 IV infusion of 2 hours 5-Fluorouracil 400 mg/m2 as a bolus 5-Fluorouracil 600 mg/m2 continuous IV infusion of 22 hours Arm B: FOLFIRI or FOLFOX, cycle to be repeated every 2 weeks If FOLFIRI: FOLFIRI as specified in arm A without Bevacizumab If FOLFOX: FOLFOX as specified in arm A without Bevacizumab Duration of Therapy For both arms, CT was repeated until progressive disease (PD) or unacceptable toxicity occurs. If unacceptable CT-related toxicity occurs in ARM A, in the absence of PD patients stopped CT and continued with only bevacizumab 5 mg/kg as a 30-min infusion every 2 weeks until progression or intolerable toxicity occurred. Second line - it is divided in two different studies (2A and 2B): Study 2A: Patients from arm A and Kras Wild Type were randomized to: * Arm C: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as defined in arm B) * Arm D: FOLFIRI or FOLFOX (the CT schedule not received in 1st line trial, as described in arm B) plus CETUXIMAB CETUXIMAB 1st cycle Day 1 400 mg/m2 infusion of 120 min 2 hrs before CT infusion 1st cycle Day 8 and subsequent cycles 250 mg/m2 infusion of 60 min 1 hr before CT infusion Patients from arm A and Kras Mutant were treated according to arm C. Study 2B: Patients from arm B and Kras Wild Type were randomized to: * Arm E: FOLFIRI or FOLFOX (the CT schedule not received in the 1st line trial, as defined in arm B) plus BEVACIZUMAB * Arm F: FOLFIRI or FOLFOX (the CT schedule not received in the first-line trial, as defined in arm B) plus BEVACIZUMAB and CETUXIMAB; cycle to be repeated every 2 weeks, whilst cetuximab will be administered weekly. * BEVACIZUMAB 2nd day of 1st cycle 5 mg/kg IV infusion of 90 min 2nd day of 2 nd cycle if well tolerated, 5 mg/kg IV infusion of 60 min 2nd day of 3 rd cycle and subsequent cycles if well tolerated, 5 mg/kg IV infusion of 30 min after the end of 5-FU bolus on the 2nd day * CETUXIMAB 1st cycle Day 1 400 mg/m2 infusion of 120 min 2 hr before CT infusion 1st cycle Day 8 and subsequent cycles 250 mg/m2 infusion of 60 min 1 hr before CT infusion If cetuximab will be stopped for any of the reasons specified in this protocol, bevacizumab will be administered as defined in arm A of the 1st line study Patients from arm B and Kras Mutant were treated according to arm E. Objectives of study The primary objective of the 1st line study is to determine whether the addition of bevacizumab to a poly-chemotherapy (polyCT) regimen (FOLFIRI or FOLFOX) improves efficacy in terms of progression-free survival (PFS). The secondary objectives of the 1st line study are to determine the Overall Response Rate (ORR) and the safety profile of the treatments administered. The primary objective of the 2nd line studies is to determine, separately for each study, whether the addition of cetuximab to a polyCT schemes (FOLFOX or FOLFIRI), or to polyCT schemes plus bevacizumab, improves efficacy in terms of PFS.The secondary objectives of the 2nd line studies are to determine the ORR, the overall survival (OS) and the safety profile of the treatments administered. Conditions: Metastatic Colorectal Cancer Intervention / Treatment: DRUG: Arm A: FOLFIRI or FOLFOX + Bevacizumab, DRUG: Arm B: FOLFIRI or FOLFOX, DRUG: Arm D: FOLFIRI or FOLFOX plus CETUXIMAB, DRUG: Arm F: FOLFIRI or FOLFOX plus BEVACIZUMAB and CETUXIMAB Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: 1. Histologically or cytologically confirmed untreated metastatic or locally advanced, non resectable CRC; previous adjuvant chemotherapy for CRC or neoadjuvant/adjuvant chemoradiotherapy for rectal cancer is permitted but must have been completed at least 6 months prior to enrolment; 2. Resected CRC patients who have developed metastases do not require separate histological or cytological confirmation unless \> 5 yrs have elapsed between primary surgery or primary tumor stage I; 3. Evaluation of Kras status from the primary tumor or metastases 4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria) 5. Age ≥ 18 years and \< 70 years with Performance Status (ECOG) ≤ 2 or age \> 70 years with ECOG ≤ 1; 6. Estimated life expectancy of at least 12 weeks; 7. Adequate hematological, hepatic and renal function, as follows: hemoglobin ≥ 9 g/dl,absolute neutrophil count ≥1,500/μL, platelets ≥100,000/μL, total bilirubin ≤1.5 x upper limit of normal (ULN),alkaline phosphatase, aspartate aminotransferase (AST(SGOT)) and alanine aminotransferase (ALT(SGPT)) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases present), serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance \>50 mL/min (calculated on the basis of Standard Cockcroft and Gault Formula, urinary excretion (if protein \> 30 mg/dL or +1, patients must have ≤ 1 g of protein/24 hours) 8. Either international normalized ratio (INR) or activated partial thromboplastin time (APTT) \< 1.5 x ULN and D-dimer within normal range (if abnormal, thromboembolic events must be excluded); 9. Negative pregnancy test no more than 7 days before randomization; test pregnancy can be omitted only in women without any reproductive potential (e.g.: postmenopausal women, i.e. amenorrhoea ≥2 years or with previous hysterectomy or bilateral ovariectomy). Women of child-bearing potential and men must agree to use adequate contraception at the time of randomization and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician and coordinating centre (CC) immediately; women in lactation period must be excluded; 10. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Prior treatment with cetuximab, bevacizumab or other anti Epidermal Growth Factor Receptor (antiEGFR) or anti-angiogenesis agents; 2. Prior chemotherapy or immunotherapy for metastatic or advanced disease; 3. Participation in another clinical trial with any investigational agents ≤ 30 days prior to study randomization; 4. Contraindications or hypersensitivity to study drugs; 5. Treatment with other concomitant antineoplastic drugs; 6. Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix); 7. Symptomatic brain or central nervous system metastases or clinically relevant central nervous diseases (for example: primary brain tumor, uncontrolled convulsions with medical therapy, carcinomatous meningitis); 8. Grade \> 1 peripheral neuropathy (as defined by the National Cancer Institute - Common Toxicity Criteria for Adverse Effects (NCI CTCAE) v3.0); 9. Clinically significant (i.e. active) cardiovascular disease e.g. cerebrovascular accidents ≤ 6 months prior to randomization), myocardial infarction (≤ 1 year prior to randomization), uncontrolled hypertension whilst receiving chronic medication, unstable angina, New York Heart Association (NYHA) grade II or more congestive heart failure,or serious cardiac arrhythmia requiring medication; 10. Malabsorption syndrome or lack of physical integrity of the gastrointestinal tract. Diverticulitis. Patients with colostomy or ileostomy may enter at the investigator's discretion. History of trachea-oesophageal fistula or any other type of fistula (e.g. abdominal), gastrointestinal perforation, intra-abdominal abscess; 11. Interstitial pneumonia or extensive symptomatic fibrosis of the lungs; 12. Serious, non-healing wound, ulcer, or bone fracture; significant traumatic injury in the 4 weeks prior to enrolment (complete recover must have occurred); 13. Major surgery (e.g. laparotomy) in the 4 weeks prior to study randomization; 14. Minor surgery in the 2 weeks prior to study randomization. Insertion of a central vascular access device for chemotherapy infusion must be done at least 2 days prior to the start of treatment. Patients will be randomized only if they have recovered from all surgery related toxicities; 15. Bleeding diathesis or coagulopathy; 16. Pulmonary embolism or any arterial thromboembolism; 17. Deep vein thrombosis or other significant thromboembolic event; 18. Clinically significant peripheral vascular disease; 19. Previous organ transplantation that requires immunosuppressive therapy; 20. Need for chronic oral steroid use ( ≥10 mg/day of methylprednisolone or equivalent) for the treatment of a nonmalignant condition other than intermittent prophylactic use as an antiemetic and inhaled steroid use; 21. Chronic use of aspirin (\> 325 mg/day) or other non steroidal anti-inflammatory agents (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases); 22. In treatment with antiplatelets agents (i.e clopidogrel \> 75 mg/day, ticlopidine,dipyridamole); 23. Undergoing treatment with sorivudine or its chemically-related analogues (such as brivudine); 24. Full-dose oral or parenteral anticoagulants or thrombolytic treatment for therapeutic purposes ≤10 days prior to study randomization; 25. Geographic inaccessibility; 26. Any radiation therapy completed ≤ 4 weeks prior to study randomization. If the radiated lesion/s is/are the only site of disease, and if it/they show progression after the radiotherapeutic procedure, the patient will become eligible for the study; 27. Previous embolization or thermoablation of metastases ≤ 30 days prior to study randomization. If these lesions are the only site of disease, and if they show progression after the embolization or thermoablation procedure, the patient will become eligible for the study; 28. Laboratory abnormality or medical or psychiatric disorders that would interfere with informed consent or compliance, or which could indicate a contraindication to patient enrolment into the study (also known dihydropyrimidine dehydrogenase deficit); 29. HIV-positivity, whether or not symptomatic.

Study Objectives A study to evaluate effectiveness of sublobar dissection in patients with non-small cell lung cancer Conditions: Non-small Cell Lung Cancer Intervention / Treatment: PROCEDURE: Sublobar dissection Location: China Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Patients \>= 18 years old; * Patients who received sublobar dissection from 2014 to 2017 (segment dissection/wedge dissection/segment and wedge dissections); * Patients who received selective or systematic lymphadenectomy; * Pathologically diagnosed patients with non-small cell lung cancer; * Pathological staging: I, II Exclusion Criteria: * Patients who received cancer treatments before surgeries (adjuvant therapies including chemotherapies, radiotherapies, target therapies); * Patients who received late-phase or intolerant palliative lobectomy or compromise sublobar dissection;

Study Objectives This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine. Conditions: Acute Myeloid Leukemia Intervention / Treatment: DRUG: vosaroxin + cytarabine, DRUG: placebo + cytarabine Location: Korea, Republic of, New Zealand, Belgium, Austria, Germany, United States, Hungary, Poland, Canada, Australia, Spain, France, United Kingdom, Czechia, Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Provided signed, written informed consent * At least 18 years of age * Had a diagnosis of AML according to World Health Organization (WHO) classification * First relapsed or refractory AML (refractory to initial induction therapy) with at least 5% blasts by bone marrow or aspirate or 1% blasts in peripheral blood with additional requirements for relapsed or refractory * Had an ECOG score of 0-2 * Had adequate liver and renal function as indicated by certain laboratory values * Had adequate cardiac function (left ventricular ejection fraction at least 40% by multiple gated acquisition scan or ECG) * Nonfertile or agreed to use an adequate method of contraception until 30 days after the last treatment * Had any clinically significant nonhematologic toxicity after prior chemotherapy recovered to Grade 1 per NCI-CTCAE Exclusion Criteria: * Had acute promyelocytic leukemia * Had more than 2 cycles of induction therapy for AML * Had completed a single cycle of treatment containing a total dose of 5 g/m2 or more of cytarabine within 90 days before randomization * Refractory to or relapsed within the previous 3 months after therapy with an IDAC- or HIDAC-containing regimen * Had received a hematopoietic stem cell transplant (HSCT) within the previous 90 days * Had received active immunosuppressive therapy for graft-versus-host disease (GVHD) within 2 weeks before study start * Had any other severe concurrent disease, or have a history of serious disease involving the heart, kidney, liver, or other organ system * Had evidence of central nervous system involvement of active AML * Had other active malignancies (including other hematologic malignancies) or been diagnosed with other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia * Had an active, uncontrolled infection * Had received any other investigational therapy within 14 days or not recovered from acute affects of the other investigational therapy * Had received prior or current hydroxyurea or medications to reduce blast count within 24 hours before randomization * Had received previous treatment with vosaroxin * Pregnant or lactating * Had any other medical, psychological, or social condition that may interfere with consent, study participation, or follow-up * Had known HIV seropositivity

Study Objectives Single -arm, multicenter phase-II trial for catumaxomab and chemotherapy in patients with recurrent ovarian cancer to investigate the feasibility and clinical activity of initial intraperitoneal catumaxomab followed by chemotherapy regimes. Conditions: Recurrent Epithelial Ovarian Cancer Intervention / Treatment: DRUG: Catumaxomab 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: * Histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer * Recurrent ovarian cancer disease * Signs for progression either measurable disease according to RECIST or CA 125 increase according the GCIG-criteria or clinical symptoms of tumor progression according to RECIST * Radiologically and cytologically confirmed malignant ascites possible to puncture * Life expectancy ≥ 12 weeks * Age ≥ 18 years * ECOG performance status at least 1 * No prior operation or, in case of prior operation, the patient must be recovered therefrom. The operation must be performed at least 4 weeks prior to start of study drug * Capable of understanding the purposes and risks of the study, willing and able to participate in the study, and written informed consent * Non-childbearing potential or negative pregnancy test Exclusion Criteria: * known brain metastases * Concomitant cancer, chemo- or radiotherapy (except for local radiation therapy for bone marrow metastases) * Any investigational product within 2 weeks prior to first administration of catumaxomab * In cases of previous exposure to investigational product, cancer-, chemo-, immune- or radiotherapy (except for local radiation therapy for bone marrow metastasis): not sufficiently recovered from previous treatment (toxicity present) based on adequate laboratory values and general status according to other in-/exclusion criteria (i.e. this might be less than 1 or 2 weeks after a weekly or bi-weekly scheduled previous therapy regimen) * Patients must not have been exposed to nitrosoureas or mitomycin C within 6 weeks prior the first infusion of catumaxomab * Abnormal organ or bone marrow function * Use of immune-suppressive agents for the past 4 weeks prior to first administration of catumaxomab. For regular use of systemic corticosteroids patients should only be included after stepwise discontinuation to be free of steroids for a minimum of 5 days prior to study entry * Any known active and chronic infection * Known HIV infection and / or hepatitis B virus or hepatitis C virus * Any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator * Known or suspected hypersensitivity to catumaxomab and its analogues in general or to murine proteins (from rat or mouse) * Known or suspected hypersensitivity to PLD, topotecan, paclitaxel, gemcitabine or their excipients. * Patients with congestive heart failure New York Heart Association (NYHA) Class III and IV. Cardiac arrhythmias (except atrioventricular block type I and II, atrial fibrillation/flutter bundle brunch block)or other signs and symptoms of relevant cardiovascular disease * Body mass index (BMI) \< 17 (assessment after ascites drainage) * Inadequate respiratory function in the opinion of the investigator * Presence of complete bowel obstruction * Patients with substance abuse, medical or psychological or social conditions which the investigator believes would preclude compliance with the study requirements. * Unwilling or unable to follow protocol requirements * Participation in another clinical study with experimental therapy within 14 days before start of treatment * Legal incapacity or limited legal capacity * Subjects housed in an institution on official or legal orders * Pregnancy or lactation period

Study Objectives The goal of this clinical research study is to find the highest tolerable dose of the combination of regorafenib and cetuximab that can be given to patients with advanced solid tumors. The safety and effectiveness of this drug combination will also be studied. Conditions: Advanced Cancers Intervention / Treatment: DRUG: Regorafenib, DRUG: Cetuximab, BEHAVIORAL: Questionnaire 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. Patient must be \>= 12 years of age and \> 40kgs. 2. Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months. 3. Patients must have evaluable or measurable disease by RECIST criteria for solid tumors. 4. Ability to understand and the willingness to sign a written informed consent document. 5. Patients must be \>/= 4 weeks beyond treatment with any chemotherapy or radiotherapy, and must have recovered to \</= grade 2 toxicity for any treatment-limiting toxicity of prior therapy. (Exception: patients may have received palliative low dose radiotherapy to the limbs 1-4 weeks before this therapy provided pelvis, ribs, sternum, scapulae, vertebrae or skull were not included in the radiotherapy field). Also, patients who have received non-chemotherapeutic biologic agents will need to wait at least five half-lives or four weeks, whichever is shorter, from the last day of treatment. Exception: No washout of cetuximab or regorafenib is required for patients who have received prior cetuximab or regorafenib and have recovered from any treatment-related toxicities to Grade \</= 1. 6. ECOG performance status \</= 2 (Karnofsky \>/= 60%). 7. Patients must have: leukocytes \>/= 3,000/mL; absolute neutrophil count \>/= 1,000/mL; platelets \>/=100,000/mL; creatinine \</= 2 X ULN; total bilirubin \</= 2.0; ALT(SGPT) \</= 3 X ULN; Exception for patients with liver metastasis: total bilirubin \</= 3 x ULN; AST (SGOT) and ALT(SGPT) \</= 5 X ULN. Patients should not have received any platelet transfusions in the last 4 weeks before screening date. 8. Patients should not become pregnant or breastfeed while on this study. Sexually active patients must agree to use contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose. Exclusion Criteria: 1. KRAS mutated colorectal cancer. 2. Major surgery within 28 days prior to the first dose of study medication. 3. Pregnant or lactating women. 4. Patients with hemoptysis within 28 days prior to entering the study. 5. Patients with clinically significant unexplained bleeding within 28 days prior to entering the study. 6. Uncontrolled systemic vascular hypertension (Systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg on medication). 7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1. 8. Patients with clinically significant cardiovascular disease: 1). History of CVA within 6 months; 2). Myocardial infarction or unstable angina within 6 months; 3). Unstable angina pectoris; 4). New York Heart Association Class III or greater congestive heart failure. 9. Patients with untreated or progressing brain metastases. 10. Patients who had radiation to greater than 25% marrow in the past 5 years.

Study Objectives The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab. The secondary objectives are safety and pharmacokinetic interaction Conditions: Breast Neoplasms Intervention / Treatment: DRUG: larotaxel (XRP9881), DRUG: trastuzumab Location: Sweden, France, Switzerland, Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Metastatic breast cancer (MBC) * HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ Hybridization) positive or IHC (Immunohistochemistry) 3+ * Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) * Adequate organs functions Exclusion Criteria: * More than one previous chemotherapy regimen for metastatic disease * Cardiac dysfunction

Study Objectives Prospective study on patients with orbital tumors of unknown origin. Aim of the study is to differentiate benign from malignant tumors upon MR imaging. Magnetic resonance imaging of the orbit will be performed including standard morphological sequences and advanced sequence techniques. These advanced sequence techniques may allow to differentiate benign from malignant tumors based on their cellularity and vascularity (diffusion and perfusion imaging). These MRI data will be analysed and the level of diffusion and perfusion will be measured and compared to the histological findings. Cut-off values of diffusion and perfusion will be calculated that allow to separate benign from malignant tumors. Conditions: Orbital Tumors Intervention / Treatment: OTHER: MRI Location: Germany Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * non-diagnosed orbital tumors Exclusion Criteria: * any metal implants, non-MRI compatible * age below 18 * pregnancy * recent surgery * recent severe medical diseases

Study Objectives The purpose of this research study is to learn if and in what amount a compound from hops, called xanthohumol (ZAN-tho-HUE-mol), prevents damage to DNA and oxidative stress. The human body is constantly exposed to oxidative stress from environmental compounds (e.g. air pollution) which may cause damage to DNA. The human body can repair some DNA damage, but too much DNA damage is harmful and may lead to cancer. Research done at OSU and around the world has shown that xanthohumol can stop or slow processes that lead to cancer. Conditions: Oxidative Stress Intervention / Treatment: DRUG: 6 mg xanthohumol per day, DRUG: 12 mg xanthohumol per day, DRUG: 24 mg xanthohumol per day, DRUG: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: QUADRUPLE

Inclusion Criteria: * Non-smokers or no other tobacco use in the past 3 months. * Willing to stop taking regular supplements including anti-oxidants for 2 weeks prior to study entry through conclusion of study. * Willing to stop consumption of high levels of flavonoids and xanthohumol in the normal diet (onions, teas including green/black tea and microbrew beers) for 2 weeks prior to study entry through conclusion of study. * Must be able to give written informed consent. * Blood screen tests (Comprehensive metabolic profile \[CMP\] and lipid profile) within normal limits. Exclusion Criteria: * Body Mass Index (BMI) less than 18.5 (underweight) or greater than 30 (obese) * Have a significant acute or chronic coexisting illness such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease, cancer, history of chemotherapy, celiac disease or gluten/wheat intolerance\*, diabetes, thyroid problems, or any condition which contraindicates, in the investigators judgement, entry into the study. * Currently taking prescription drugs except oral contraceptives. * Consumption of more than the recommended alcohol guidelines i.e. \>2 drinks/day. * Consumption of high levels of flavonoids and xanthohumol in the normal diet (onions, teas including green/black tea and microbrew beers). * Pregnancy (as confirmed by urine pregnancy test), breastfeeding, or planning to become pregnant before completing the study. * Undergoing UV therapy (e.g. treatment for skin conditions such as psoriasis), using UV tanning beds, or unprotected sun exposure greater than 1 hour per day. * Engaging in vigorous exercise more than 6 hours per week. * Participation in another dietary study in the past 3 months. * Had surgery in the last 3 months. * Post-menopausal status (\*Note: Beverage is formulated with a barley extract. Barley contains gluten.)

Study Objectives Until recently, bolus 5-flourouracil (FU) + folinic acid (FA) has been considered the standard chemotherapy for patients with colorectal cancer. Several studies have shown that Capecitabine is as effective as Mayo regimen. The Nordic FU/FA schedule was developed to be an active and tolerable bolus regimen. The Nordic regimen consists of a short (3 minutes) bolus injection of FU and 30 minutes later FA for 2 consecutive days each 2 weeks. In randomized studies efficacy is comparable to other FU/FA regimens. It is claimed that patients prefer oral therapy and in a randomized study comparing oral therapy (UFT/FA) and bolus FU/FA (Mayo) 84% preferred oral therapy. In the present randomized cross-over study patients were randomized for 3 courses of Nordic FU/FA followed by 2 courses of Capecitabine (or vice versa), and patients were asked for their preference. Conditions: Colorectal Cancer Intervention / Treatment: DRUG: Capecitabine, DRUG: Fluorouracil + folinic acid Location: Denmark Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: DOUBLE

Inclusion Criteria: * Indication for treatment with a FU-regime * WHO Performance Status 0-1 * Life expectancy \> 3 months * Adequate haematological, renal and hepatic functions * Adequate contraceptives * Written informed consent Exclusion Criteria: * Known CNS-metastases * Prior treatment with chemotherapy * Pregnant or breast feeding women * Current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis * other serious illness or medical conditions

Study Objectives This phase Ⅱ study was designed to evaluate the efficacy and safety of FOLFIRI as second-line treatment for metastatic esophageal carcinoma. Conditions: Advanced Esophageal Carcinoma Intervention / Treatment: DRUG: FOLFIRI Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients have provided a signed Informed Consent Form * Karnofsky score ≥70 * Age: 18-75 years old * Histologically confirmed diagnosis of advanced esophageal carcinoma * Patients have Received and progressed on first-line treatment, and not received CPT-11 or Fluoropyrimidine based palliative chemotherapy * Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria * Life expectancy ≥ 3 months * Patient has adequate bone marrow and organ function * Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L * Platelets ≥ 75 x 109/L * Hemoglobin ≥ 9.0 g/dL * Patient has adequate liver function * AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis) * Serum bilirubin ≤ 2 x ULN * Creatinine ≤ 1.5 times ULN * Good compliance Exclusion Criteria: * Pregnant or lactating women * Brain metastasis or only with bone metastasis. * Patients with severe infection or active peptic ulcer which need treatment * Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases * Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ * Psychiatric illness that would prevent the patient from giving informed consent * Patient is concurrently using other approved or investigational antineoplastic agent

Study Objectives RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy. PURPOSE: Phase I trial to study the effectiveness of high-dose radiation therapy planned using a 3-dimensional picture of the tumor in treating patients who have stage I, stage II, or stage III non-small cell lung cancer. Conditions: Lung Cancer Intervention / Treatment: 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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Clinical stage T1-4, N0-2, M0 * Clinical stage T1-2, N0-1 must be medically inoperable * No distant metastases on history and physical exam, CBC, screening profile, CT or MRI of brain, CT of chest and abdomen (including adrenals and liver), and bone scan * No pleural effusions * Atelectasis not clearly distinguishable from tumor mass allowed provided all tumor and atelectasis together represent a volume that can be safely treated to the total dose delivered to gross disease * Diffuse pulmonary infiltrates thought to represent benign disease allowed only if representative lesion samples are proven by biopsy or cytology not to contain cancer * No diffuse bronchoalveolar carcinoma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other malignancy within the past 5 years except nonmelanomatous skin cancer or noninvasive cervical carcinoma * No other medical illness that cannot be adequately controlled with appropriate therapy or that is considered severe enough to preclude a radical treatment approach PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy for lung cancer Chemotherapy * No prior chemotherapy for lung cancer Endocrine therapy * No prior endocrine therapy for lung cancer Radiotherapy * No prior radiotherapy for lung cancer Surgery * No prior surgery for lung cancer

Study Objectives Accrue samples for the further development and clinical validation of a blood-based cell-free DNA (cfDNA) quantitative real-time polymerase chain reaction (qPCR) assay as a potential biomarker for early non-response to therapy in stage IV non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer (BC). Conditions: Metastatic Non-Small Cell Lung Carcinoma, Metastatic Colorectal Cancer, Metastatic Breast Cancer Intervention / Treatment: DIAGNOSTIC_TEST: Blood-based cell-free cfDNA qPCR assay Location: Canada, United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: Age ≥ 18 years. Documented stage IV NSCLC, SCLC, BC or CRC (can be new diagnosis, persistent or recurrent disease): BC patients who meet the following criteria: ER+/HER2- and has failed hormone therapy within the last two years, or ER+/HER2+ or, ER-/HER+ or, HER2-/ER-/PR- (TNBC), and Has ≥ 1 measurable non- bone lesion as measured per RECIST or, If bone only disease, has two or more measurable (\> 1 cm by RECIST) predominantly lytic bone lesions Planned initiation of new systemic first- or second-line treatment or subsequent therapies with chemotherapy, immunotherapy, targeted therapy or combination thereof. Or continuation of the current line of therapy after RECIST/iRECIST evaluation which coincides with end of the cycle of therapy and prior to initiation of the next cycle of therapy. Imaging to determine RECIST and/or iRECIST criteria: If baseline blood draw is planned prior to first cycle of a line (1st, 2nd, 3rd etc) of therapy, measurable disease with CT or MRI or PET/CT monitoring should be completed within 4 weeks prior to baseline blood draw. If baseline test is performed at the completion of a cycle of therapy, CT or MRI or PET/CT monitoring should be completed to coincide with end of cycle of therapy and prior to baseline blood draw. Planned CT or MRI or PET/CT monitoring for treatment response completed within 8-12 weeks of start of treatment. Willing and able to donate up to 30mL of blood at each blood draw. Willing and able to provide informed consent. Exclusion Criteria: Diagnosis of a secondary malignancy that is not in complete remission. Imaging to determine RECIST and/or iRECIST criteria is not planned or available. CT or MRI or PET/CT monitoring for treatment response is not planned within 8-12 weeks. Presence of active autoimmune disease which is under active treatment. DVT, PE, sepsis, or has recovered from any other serious illness within the prior 2 weeks of the baseline blood draw. (Note: Patients who have recovered from similar conditions more than 2 weeks prior to the baseline blood draw would be eligible for the study) If initiating a new line of therapy, patient has received any doses of the new block of therapy before the first designated blood draw. If continuing current line of therapy after CT, MRI or PET/CT monitoring, patient has received subsequent cycle of therapy before the first designated blood draw. Performance status ECOG ≥3. Evidence of acute renal failure as determined by current clinical guidelines. NSCLC, SCLC or CRC patients beyond 9 months of the initiation of therapy, on 1st line immunotherapy alone, or combination immunotherapy and chemotherapy regimens. (Note: patients on subsequent lines of therapy (2nd,3rd line etc.) would be eligible at any time point including prior to the 9 months vs those patients on 1st line therapy)..

Study Objectives Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in subjects with advanced melanoma or metastatic TNBC Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination Hypothesis: Restore (for melanoma) or enhance (for TNBC) sensitivity to checkpoint inhibitors (CPI) by appropriate and effective stimulation of the subject's innate and adaptive immune systems in those subjects who have failed 1st line therapy The study will incorporate Simon's optimal 2-stage design with sample size fixed at 12 subjects each in Stage 1 for advanced melanoma and for Triple Negative Breast Cancer (TNBC) subjects. The safety criterion of ≤ 4 (or ≤ 33%) subjects with Grade 3/4 adverse events in Cycle 1 within either tumor type must be met in order to proceed to Stage 2. The starting dose is 4 mg/kg for Imprime PGG. In the event there are a total of \> 4 (or \> 33%) of subjects with Grade 3/4 adverse events in Cycle 1, the dose of Imprime PGG will be reduced to 2 mg/kg, and Stage 1 will be repeated at a dose of 2 mg/kg with an additional cohort of n=12 subjects. For the dose that meets the safety criterion in Stage 1, at least 1 response in melanoma subjects and 2 responses in TNBC subjects amongst the 12 subjects within each tumor type must be observed in order to proceed to Stage 2. Stage 2 will enroll an additional 17 subjects with melanoma, and 30 subjects with TNBC. For the dose that meets the Stage 1 safety criterion, success will be declared if at least 4 amongst the total of up to 29 subjects with melanoma, and 13 amongst the total of up to 42 subjects with TNBC achieve an objective response. Conditions: Advanced Melanoma, Triple-Negative Breast Cancer Intervention / Treatment: BIOLOGICAL: Imprime PGG, DRUG: Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: 1. Have signed an informed document prior to any study-specific procedures or treatment 2. Be ≥ 18 years of age at time of consent 3. For Melanoma Subjects: Have histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic (Stage IV) melanoma not amenable to local therapy, and irrespective of PD-L1 status 4. For TNBC Subjects: Have histologically or cytologically confirmed diagnosis of metastatic (Stage IV) TNBC, and irrespective of PD-L1 status. TNBC is defined as negative immunohistochemistry (IHC) assays for Estrogen Receptor (ER), and Progesterone Receptor (PR), and HER2 negative (IHC 0 or 1+, or 2+ by IHC confirmed negative by FISH) 5. Have documented objective radiographic or clinical disease progression after PD-1/PD-L1 +/- anti-CTLA-4 inhibitor therapy (melanoma) or after at least 1 line of chemotherapy for metastatic disease (TNBC) 6. Have resolution of all previous treatment-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (less than or equal to Grade 2) or alopecia. If subject received major surgery or radiation therapy of \> 30 Gy, must have recovered from the toxicity and/or complications from the intervention. 7. Have at least one radiologically measurable lesion as per RECIST v1.1 defined as a lesion that is at least 10 mm in longest diameter or lymph node that is at least 15 mm in short axis imaged by CT scan or MRI and obtained by imaging within 28 days prior to start of study treatment. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. 8. Have peripheral blood levels of IgG anti-β-glucan antibody (ABA) of ≥ 20 mcg/mL as determined by an ELISA test within 28 days prior to start of study treatment 9. Be willing to consider providing fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality, for assessment of biomarker status. Repeat samples may be required if adequate tissue is not provided. Newly obtained biopsy specimens are preferred to archived samples and formalin-fixed, paraffin-embedded block specimens are preferred to slides. Note: Information on 1 tumor biopsy sample is mandatory and is as follows: (1) To determine eligibility, historical (diagnostic) tumor biopsy official pathology report +/- an archival sample. Additional biopsy samples, preferably obtained from the same localized region, are highly desirable when feasible at the following time points: (2) Sample before the first dose of study treatment, (3) Sample after completion of Cycle 2 but before the start of Cycle 3 dosing, and (4) Sample either at the time of response or at the End of Study Visit (if no response). 10. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 14.3) 11. Have life expectancy of 3 months or greater as determined by the treating physician 12. Have adequate organ function (all screening labs should be performed within 15 days prior to treatment initiation): 1. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) OR direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 x ULN 2. Aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases 3. Alanine aminotransferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN for subjects with known hepatic metastases 13. Have adequate renal function as defined by the following criteria: Creatinine ≤ 1.5 x ULN and CrCl ≥ 30 ml/min per Cockcroft Gault formula: 14. Have adequate hematologic function, defined as meeting all of the following criteria: 1. Hemoglobin ≥ 9 g/dL (uncorrected by RBC transfusion) 2. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L 3. Platelet count ≥ 100 × 109/L 15. Have adequate coagulation functioning within 15 days prior to start of study treatment, defined by either of the following criteria: 1. INR \< 1.5 × ULN 2. OR for subjects receiving warfarin or low molecular weight heparin (LMWH), the subjects must, in the Investigator's opinion, be clinically stable with no evidence of active bleeding while receiving anticoagulant therapy. The INR for these subjects may exceed 1.5 × ULN if that is the goal of anticoagulant therapy. 3. Activated Partial Thromboplastin Time (aPTT) \< 1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants 16. Female subjects of childbearing potential as defined in Section 5.7.2 must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 17. If of childbearing potential as defined in Section 5.7.2, must be willing to use an adequate method of contraception (see Section 5.7.2) from the first dose of study medication through 120 days after the last dose of study medication 18. Be willing and have the ability to comply with scheduled visits (including geographical proximity), treatment plans, laboratory tests, and other study procedures Exclusion Criteria: 1. Has disease that is suitable for local therapy administered with curative intent 2. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment 3. Has a diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor. 4. Has known history of active tuberculosis 5. Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) 6. Has known active Hepatitis B (eg, HBsAg reactive) or Hepatitis C (eg, HCV RNA \[qualitative\] is detected 7. Has a history of clinically severe autoimmune disease, or history of organ transplant 8. Has a history of ocular melanoma 9. Has known hypersensitivity to baker's yeast 10. Had previous exposure to Betafectin® or Imprime PGG 11. Has hypersensitivity to pembrolizumab or any of its excipients 12. Had a prior anti-cancer monoclonal antibody (except immune CPI in the case of melanoma subjects) within 30 days prior to start of study treatment, or failure to recover to CTCAE Grade 1 or better from the adverse events of prior therapies 13. Had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Study Day 1 or who has not recovered from adverse events due to a previously administered agent or major surgery 14. Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF, or recombinant erythropoietin) within 4 weeks prior to Study Day 1 15. Has known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 16. Has known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability. 17. Has active autoimmune disease requiring systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteriod replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. 18. Has evidence of (non-infectious) pneumonitis that required steroids or current pneumonitis 19. Has a history of interstitial lung disease 20. Has an active infection requiring systemic therapy 21. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator 22. Has a clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome within ≤180 days prior to start of study treatment, symptomatic or uncontrolled arrhythmia, congestive heart failure, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification 23. Has a known psychiatric or substance abuse disorder(s) that would interfere with informed consent or cooperation with the requirements of the trial 24. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment 25. With TNBC has received prior therapy with an anti-PD-1, anti-PD-L1, anti-CTLA-4, or anti-PD-L2 agent 26. Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted

Study Objectives The purpose of this study is to see whether the combination of avelumab and talazoparib can be an effective treatment for metastatic renal cell carcinoma. Conditions: Metastatic Renal Cell Carcinoma, Fumarate Hydratase Deficient Renal Cell Carcinoma, Succinate Dehydrogenase Deficient Renal Cell Carcinoma Intervention / Treatment: DRUG: Talazoparib, DRUG: Avelumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Biopsy proven, histological confirmed renal cell carcinoma (RCC) or renal medullary carcinoma (RMC).. Patients with surgery and biopsy at outside institutions will be eligible for this protocol once archival material is reviewed and the above diagnosis confirmed by genitourinary pathology review at Memorial Sloan Kettering Cancer Center (MSKCC). Cohort 1: (Closed to Accrual) * Presence of VHLalteration by next-generation sequencing (NGS) with a stateapproved assay * Patients must have radiographic evidence of disease progression after treatment with at least one prior PD-1 or PD-L1 agent, and one prior VEGF inhibitor * Maximum 3 prior lines of therapy Cohort 2: * For FH/SDH patients FH- or SDH- expression-loss by immunohistochemistry (IHC) or alteration (somatic or germline) in FH or SDH per NGS with a state-approved assay * For Renal Medullary Carcinoma (RMC) patients: histologic confirmation of RMC (no IHC/NGS criteria required) * At least one prior line of therapy: * For FH/SDH patients Patients must have radiographic evidence of disease progression after treatment with at least one prior line of therapy (one prior PD-1/PD-L1 and/or VEGF inhibitor). * For Renal Medullary Carcinoma (RMC) patients prior radiographic evidence of disease progression on/after at least one line of chemotherapy (e.g. carboplatin / paclitaxel, carboplatin / paclitaxel / bevacizumab, carboplatin / gemcitabine, and gemcitabine / doxorubicin). * No maximum lines of therapy Both Cohorts 1 \& 2 * Adequate Hematologic Function * Absolute Neutrophil Count ≥ 1.5 x 10\^9 / L * Platelet Count ≥ 100 x 10\^9 / L * Hemoglobin ≥ 9 g/dL * No transfusion of packed red blood cells or platelets within 21 days of Cycle 1 Day 1 * Adequate Renal Function ≥ 30 ml/min according to the Cockcroft-Gault Equation * Patients with moderate renal impairment (creatinine clearance 30-59 by Cockcroft-Gault EquationI) will start with a reduced dose of talazoparib. * Adequate Hepatic Function including: * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * AST ≤ 3 x upper limit of normal (ULN) without liver metastasis * ALT ≤ 3 x upper limit of normal (ULN) without liver metastasis * AST or ALT ≤ 5 x upper limit of normal (ULN) for patients with liver metastasis * Patients with known Gilbert's syndrome may be included if total bilirubin ≤ x 3 ULN * Eastern Cooperative Group (ECOG) Performance Status 0-2. * Patients must have measurable disease by RECIST v1.1. At least one measurable lesion should not have been previously irradiated. * Women of childbearing potential must have negative serum pregnancy testing at screening. All women will be considered childbearing potential unless meeting criteria including: * Achieved post-menopausal status as defined by cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have follicular stimulation hormone showing postmenopausal state. Women who have been amenorrhoeic for ≥12 months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anorexia, low body weight, ovarian suppression, anti-estrogen therapy or other medically inducible reasons. * Documented hysterectomy or bilateral oophorectomy surgery * Medically confirmed ovarian failure * Sexually active participants and their partners must agree to use medically accepted methods of contraception (i.e. barrier methods including condoms, female condom, or diaphragm with spermicidal gel) during the study and for 7 months after the last dose of the study treatment for females, and 4 months for males. * Recovery of baseline CTCAE v5.0 grade ≤1 toxicities related to prior study treatments unless adverse events are clinically non-significant and/or stable on supportive therapy if needed. * Patients must be willing and able to comply with trial protocol. This includes adhering to the treatment plan, scheduled visits, laboratory and other study procedures. Exclusion Criteria: * Patients \< 18 years old * Patients who are pregnant or breast-feeding. Fertile patients who are unwilling or unable to use two methods of contraception (at least one of which considered highly effective) for duration of study and after 7 months after last dose of study treatment for female, and 4 months for males. * Patients who had prior immune checkpoint blockade therapy (either anti-PD-1, anti- PD-L1 and/or anti-CTLA-4) discontinued due to development of an immune related adverse event. * Prior diagnosis of myelodysplastic syndrome (MDS) or diagnosis of other malignancy that requires anti-cancer directed therapy within the last 24 months. Exclusions include those cancers that are considered cured by local therapy (i.e.Basal cell carcinoma, squamous cell carcinoma, ducal carcinoma in situ of breast, bladder of cervix) or other cancers that have low malignant potential and do not require systemic therapy (i.e. Gleason-grade \<6 prostate adenocarcinoma, borderline ovarian malignancy / low malignant potential). * Prior treatment with talazoparib or other agents that target PARP * Treatment with anti-cancer therapies within 21 days or five half-lives, whichever shorter, of start date, including monoclonal antibody, cytotoxic therapy, or another investigational agent. There is no specific time window between last PD-1/PD-L1 therapy and start date of new therapy on protocol. * Significant vascular disease (i.e. aortic aneurysm requiring surgical repair, recent arterial thrombosis) within 6 months prior to first dose of therapy. * Evidence of bleeding diathesis or significant unexplained coagulopathy (i.e. absent of anticoagulation) * Clinical signs or symptoms of gastrointestinal obstruction requirement parenteral hydration, parenteral nutrition, or feeding tube. * Uncontrolled effusion management (pleural effusion, pericardial effusion, or ascites) which requires recurrent drainage procedures. * Patients treated with systemic immunosuppressants; except for 1. chronic physiologic replacement of ≤ 10mg prednisone (or equivalent) for treatment of adrenal insufficiency; Steroids required for pre-medication reactions 2. Local steroid use is permitted (e.g. intranasal, topical, inhaled, or local steroid injection, i.e. intra-articular) * Patients with autoimmune disease that may worsen during immune checkpoint blockade therapy are excluded. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requirement immunosuppressive treatment as above are eligible. * Prior organ transplantation including allogeneic stem cell transplant. * No active infection requiring parenteral antibiotic therapy. * Prior diagnosis of HIV/AIDS * History of either positive HCV RNA viral load or anti-HCV antibody screening detectable; HBV infection with HBV surface antigen detection and/or positive HBV DNA viral load. * Known hypersensitivity to talazoparib or avelumab, or any component in formulations. Patients with known hypersensitivity to monoclonal antibodies (Grade ≥3 by CTCAE v5.0) * Live vaccination within 4 weeks of first dose of therapy. All vaccines except inactivated are prohibited while on study. * Severe acute or chronic medical conditions which may significantly increase the risk of study participants, per treating investigator's discretion * Radiation therapy to any site (including bone) \<2 weeks prior to the first dose of therapy. Patients with clinically relevant ongoing complications from prior radiation therapy, per investigators' assessment, are not eligible. * Symptomatic brain metastasis or leptomeningeal disease requiring steroid use. Patients are eligible if they neurologically stable for 4 weeks, and have completed radiation therapy or surgery, and recovered from side effects. Patients must have discontinued steroid therapy for at least 2 weeks prior to first dose of study treatment. * Current or anticipated use of potent P-gp inhibitors within 7 days prior to randomization or anticipated use during the study. Please see Appendix 5 for a list of potent P-gp inhibitors. * Inability to swallow capsules, known intolerance to talazoparib or its excipients, known malabsorption syndrome, or other conditions which impair intestinal absorption. * Investigator site staff members directly involved in study conduct, including but not limited to their family members, or patients who are Pfizer members, including their family members, who are directly involved in study conduct.

Study Objectives CMP-001-007 is a Phase 2 study of CMP-001 intratumoral (IT) and pembrolizumab intravenous (IV) administered to participants with head and neck squamous cell carcinoma (HNSCC) who have not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody. The primary objective of the study is to determine the Investigator-assessed confirmed objective response with CMP-001 in combination with pembrolizumab in subjects with head and neck squamous cell carcinoma (HNSCC) The secondary objectives are to: * To evaluate the safety and tolerability of CMP-001 administered by intratumoral (IT) injection in combination with pembrolizumab in subjects with HNSCC * To evaluate the efficacy of CMP-001 in combination with pembrolizumab in subjects with HNSCC * To evaluate the effect of human papillomavirus (HPV) infection and programmed death-ligand 1 (PD-L1) expressions on the efficacy of CMP-001 in combination with pembrolizumab Participants will continue to receive treatment of CMP-001 and pembrolizumab according to the treatment schedule until a reason for treatment discontinuation is reached. Conditions: Squamous Cell Carcinoma of Head and Neck Intervention / Treatment: DRUG: CMP-001, DRUG: Pembrolizumab Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically- or cytologically-confirmed recurrent or metastatic HNSCC considered incurable by local therapies. * No prior systemic therapy in the recurrent or metastatic setting. Systemic therapy as part of multi-modal treatment for locally advanced disease is allowed. * Primary tumor locations of oropharynx, oral cavity, hypopharynx, larynx or paranasal sinus. Participants may not have a primary tumor site of nasopharynx (any histology). * Able to provide tissue from a core or excisional biopsy (fine needle aspirate is not sufficient). A newly obtained biopsy (within 90 days before the start of study treatment) is preferred but an archival sample is acceptable. * Combined Positive Score (CPS) ≥ 1 for PD-L1 on Immunohistochemistry (IHC) of tumor tissue. * Have results of tumor HPV p16 by IHC for oropharyngeal cancer. * Measurable disease as defined by RECIST v1.1, and both of the following: 1. At least 1 lesion amenable to repeated Intratumoral (IT) injection. 2. Documented disease progression in any lesion that was previously radiated in order to serve as a target lesion. * Adequate organ function based on most recent laboratory values within 3 weeks before the first dose of study drug on Week 1 Day 1 (W1D1) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening. * Capable of understanding and complying with protocol requirements. * Women of childbearing potential must have negative serum pregnancy test during Screening and be willing to use an adequate method of contraception from the time of consent until at least 120 days after the last dose of study drug. * Male subjects must be surgically sterile or must agree to use adequate method of contraception from the time of consent until at least 120 days after the last dose of study drug. * Able and willing to provide written informed consent and to follow study instructions. * Subjects unable to provide written informed consent on their own behalf will not be eligible for the study. Exclusion Criteria: * Disease suitable for local therapy administered with curative intent. * Has PD within 3 months of completion of curatively intent systemic treatment for locoregionally advanced HNSCC. * Radiation therapy (or other non-systemic therapy) within 2 weeks before the first dose of study drug on W1D1. * Received prior therapy with PD-1 or PD-L1 blocking antibody therapy in the recurrent/ metastatic setting. If PD-1 or PD-L1 blocking antibody therapy was given as part of curative intent therapy, it must be at least 1 year since receipt of PD-1 or PD-L1 blocking antibody. * Not fully recovered from adverse events (to Grade 1 or less \[per CTCAE v5.0\]), with the exception of persistent alopecia, neuropathy, ototoxicity, hypothyroidism, pain, or dysphagia, due to prior treatment. * Requires systemic pharmacologic doses of corticosteroids greater than the equivalent of 10 mg/day prednisone within 30 days before the first dose of study drug on W1D1. 1. Subjects who are currently receiving steroids at a prednisone-equivalent dose of ≤ 10 mg/day do not need to discontinue steroids prior to enrollment. 2. Replacement doses, topical, ophthalmologic, and inhalational steroids are permitted. * Active pneumonitis, history of noninfectious pneumonitis that required steroids, or history of interstitial lung disease. * Severe uncontrolled cardiac disease within 6 months of Screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis within the previous 6 months, cerebrovascular accident, implanted or continuous use of a pacemaker or defibrillator. * Known history of immunodeficiency. * Known additional malignancy that is progressing or required active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, in situ cervical cancer on biopsy or a squamous intraepithelial lesion on Papanicolaou smear, and thyroid cancer (except anaplastic). * Active autoimmune disease that has required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment * Untreated, symptomatic, or enlarging central nervous system (CNS) metastases or carcinomatous meningitis. * Prior allogenic tissue/solid organ transplant. * Active infection requiring systemic therapy. * Known or suspected active infection with SARS-CoV-2 virus. * Known or suspected infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus; testing is not required unless suspected. * Received a live virus vaccination within 30 days before the start of study drug dosing on W1D1. * Received blood products (including platelets or red blood cells) or colony stimulating factors \[including granulocyte colony-stimulating factor (GCSF), granulocyte-macrophage colony-stimulating factor (GMCSF) (or recombinant erythropoietin)\] within 30 days before the start of Screening. * Any concurrent uncontrolled illness, including mental illness or substance abuse, which in the opinion of the Investigator, would make the subject unable to cooperate or participate in the trial. * Participation in another clinical trial of an investigational anticancer therapy or device within 30 days before the first dose of study drug. * Requires prohibited treatment (ie. non-protocol specified anticancer pharmacotherapy, surgery or conventional radiotherapy for treatment of malignant tumor). * Has a life expectancy of less than 3 months and/or has rapidly progressing disease (eg. tumor bleeding, uncontrolled tumor pain) in the opinion of the treating Investigator. * Received previous CMP-001 treatment. * Pregnant or breast-feeding or expecting to conceive or father children within the projected duration of the study, from the time of consent until at least 120 days after the last dose of study drug.

Study Objectives To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN). Conditions: Usual Type Vulval Intraepithelial Neoplasia (uVIN) Intervention / Treatment: DRUG: Omiganan (CLS001) topical gel, DRUG: Vehicle topical gel Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: 1. Women ≥ 18 years 2. Biopsy proven uVIN, biopsies to have been taken within the last three months 3. Written informed consent to participate in the trial 4. At least one lesion that can be accurately measured (using RECIST criteria) * in at least one dimension with longest diameter ≥ 20mm * OR in two perpendicular dimensions that when multiplied together give a surface area of ≥ 120mm2 (e.g. 15mm x 8mm or 12mm x 10mm) * This is to ensure that 4x4mm biopsies can be performed on this lesion. Exclusion Criteria: 1. Has any concomitant disease or significant medical conditions that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial. 2. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis) or ECG. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects. 3. Indication of a current active infectious disease of the vulva, other than HPV 4. Pregnant, breast feeding or trying to conceive 5. Active treatment for uVIN (i.e. surgical excision, lasertherapy, imiquimod, photodynamic therapy) within the previous month 6. Patients receiving immunosuppressive therapy 7. HIV positive or transplant patients 8. Any condition that in the opinion of the investigator could interfere with the conduct of the study

Study Objectives RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment on patients with cancer. PURPOSE: This clinical trial studies the impact of therapy on the health status and quality of life of patients with stage I or stage II Hodgkin's disease who are receiving radiation therapy with or without chemotherapy. Conditions: Lymphoma, Psychosocial Effects of Cancer and Its Treatment Intervention / Treatment: PROCEDURE: psychosocial assessment and care, PROCEDURE: quality-of-life assessment Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: Patients must be eligible for and registered to SWOG-9133 PATIENT CHARACTERISTICS: Patients must be able to complete the questionnaires in English. If they are not able to complete questionnaires in English, patients may be registered to SWOG-9133 without participating in SWOG-9208. The Symptom and Personal Information Questionnaire #1, the Cancer Rehabilitation Evaluation System Short Form (CARES-SF) and Cover Sheet must be completed prior to registration and randomization on SWOG-9133.

Study Objectives Testing two different strategies for weight loss intervention and revealing possible changes in composition of gut microbiota, in order to provide more insight in the effect of dietary changes and weight loss treatments on gut microbiome in overweight and obese women with polycystic ovary syndrome (PCOS). The two strategies are: * dietary advice plus myo-inositol and folic acid * dietary advice plus liraglutide, glucagon-like peptide-1 (GLP-1) receptor agonist Primary outcome will be weight loss. Secondary outcomes are longitudinal changes in clinical features associated with PCOS and metabolic syndrome, longitudinal changes in gut microbiome with interventions. Subjects will be treated during 16 weeks and follow-up will take 16 weeks after stop of treatment. Conditions: PCOS, Obesity, Metabolic Syndrome Intervention / Treatment: DIETARY_SUPPLEMENT: dietary advice plus myo-inositol and folic acid, DRUG: dietary advice plus Liraglutide Pen Injector Location: Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * PCOS according to ROtterdam criteria * BMI ≥ 27 kg/m2 and at risk of metabolic syndrome or BMI ≥ 30 kg/m2 Exclusion Criteria: * pregnancy * pancreatitis (in the past) * oral contraceptive pill use * inflammatory bowel disease * auto-immune disease * immuno-modulatory drugs * antidiabetic drugs * anti-inflammatory drugs

Study Objectives This study is an open label, multicenter phase 2 study. The primary objective of the study is to determine the efficacy of brentuximab vedotin in patients treated by gemcitabine for relapsed or refractory peripheral T-cell lymphoma in term of overall response rate assessed after 4 cycles of treatment according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response). Conditions: Refractory Peripheral T-Cell Lymphoma, Relapsed Peripheral T-Cell Lymphoma Intervention / Treatment: DRUG: Brentuximab Vedotin - induction, DRUG: Gemcitabine, DRUG: Brentuximab Vedotin - maintenance, PROCEDURE: autologous or allogeneic stem cell transplantation Location: France, Belgium Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Males and females of 18 years to 80 years of age; * Understand and voluntarily sign an informed consent document prior to any study related assessment or procedure; * Patients able to adhere to the study visit schedule and protocol requirements; * Patients with histologically proven, CD30 positive (at least 5% of cells according to local examination) peripheral T-cell lymphoma (PTCL) according to the 2016 World Health Organization (WHO) classification for whom gemcitabine treatment is expected. A biopsy at relapse is highly recommended; * Patients who have evidence of relapsed disease after at least one line (and no more than three lines) of treatment or who were refractory to a first or subsequent line of treatment; * Patients with Ann Arbor stage I - IV; * Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2; * Patients with at least one measurable disease, i.e. one nodal or extra-nodal lesion of 1.5 cm or more; * Negative pregnancy test for females of childbearing potential (FCBP); * Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 6 months thereafter. * Males must use an effective method of birth control during treatment period and 6 months thereafter. Exclusion Criteria: * Any significant medical condition or laboratory abnormality unrelated to PTCL, or psychiatric illness that would prevent the patient from participating in the study and from signing the informed consent form; * Any condition that confounds the ability to interpret data from the study; * Other types of lymphomas, e.g. B-cell lymphoma; * Central nervous system and/or meningeal involvement by PTCL; * Signs or symptoms of Progressive Multifocal Leukoencephalopathy; * Preexistent peripheral neuropathy ≥ grade 2, whatever the cause; * Contraindication to any drug contained in the chemotherapy regimen; * Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin; * Subjects with HIV or HTLV1 positivity; * Subjects with active hepatitis B or C. Chronic carriers of hepatitis B without hepatitis B virus (HBV) DNA positive blood are eligible. Subjects with non-active hepatitis C (with normal transaminases) are eligible; * Chronic or acute, clinically significant, untreated bacterial, viral or fungal infection; * Any of the following laboratory abnormalities: 1. Absolute neutrophil count (ANC) \< 1500 cells/mm3 (1.5 x 109/L); 2. Platelet count \<75,000/mm3 (75 x 109/L); 3. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3.0 x upper limit of normal (ULN). AST or ALT may be elevated up to 5 x ULN if their elevation can be ascribed to the presence of hematologic/solid tumor in the liver; 4. Serum total bilirubin \> 1.5 x ULN; 5. Serum lipase level \> 2 x ULN; 6. Serum creatinine \> 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance \< 40 mL/minute; 7. Hemoglobin \< 8g/dL; * Active malignancies other than PTCL requiring systemic treatment; * Previous treatment with brentuximab vedotin; * Previous treatment with gemcitabine; * Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study; * Known history of any of the following cardiovascular conditions: 1. Myocardial infarction within 2 years of enrollment 2. New York Heart Association (NYHA) Class III or IV heart failure 3. Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities 4. Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction \<50% * Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment; * Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.

Study Objectives This phase I trial is studying the side effects and best dose of tipifarnib and etoposide in treating older patients with newly diagnosed acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with etoposide may kill more cancer cells Conditions: Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia Intervention / Treatment: DRUG: tipifarnib, DRUG: etoposide 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: * Adults age with established, pathologically confirmed diagnoses of newly diagnosed AML, including de novo and secondary AMLs but excluding newly diagnosed acute progranulocytic leukemia (APL, M3), will be considered eligible for study * ECOG performance status 0-2 * Patient must be able to give informed consent * Serum creatinine =\< 2.0 mg/dl * SGOT and SGPT =\< 5 x upper limit normal (ULN) * Bilirubin =\< 2 mg/dl * Disease-specific criteria: * Newly diagnosed AML, subtypes M0,1,2,4-7 but excluding M3 (APL), including myelodysplasia (MDS)-related AML (MDS/AML) and treatment-related AML * Patients who have received hydroxyurea alone or have received non-cytotoxic therapies previously for MDS (e.g., thalidomide, interferon, cytokines, 5-azacytidine) will be eligible for this trial Exclusion Criteria: * Any previous treatment with R115777 or VP-16 * Patients receiving concomitant chemotherapy, radiation therapy or immunotherapy * Hyperleukocytosis with \>= 30,000 blasts/uL or rapidly rising blast count with projected doubling time of =\< 2 days * Acute progranulocytic leukemia (APL,M3) * Active CNS leukemia * Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible * Presence of other life-threatening illness * Patients with mental deficits and/or psychiatric history that preclude them from giving informed consent or from following protocol * Patients on enzyme-inducing anti-convulsants (e.g., phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine); patients may be changed to non-enzyme inducing anti-convulsants and stabilized before starting study treatment

Study Objectives This is a randomized controlled trial that will evaluate the effectiveness of different reminder modalities for a population-based mailed FIT program at the VA Puget Sound among average risk Veterans who are due for annual colorectal cancer (CRC) screening. Conditions: Colorectal Cancer Intervention / Treatment: OTHER: Reminder Phone, OTHER: Reminder Text Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SCREENING Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: TRIPLE

Eligible participants are automatically enrolled in this project. We are unable to enroll participants upon request. Inclusion Criteria: * Veterans assigned to a primary care provider at the VA Puget Sound as of January 1, 2021 * At least 1 year of prior data available (evidence of at least one outpatient visit). * Due for annual CRC screening Exclusion Criteria: * Not scheduled for either a screening or diagnostic colonoscopy within the following 12 weeks from assessment. * No indication of current receipt of hospice care or record of recent death in the administrative data. * No personal history of CRC or history of prior colectomy.

Study Objectives To study the drug-related pneumonitis during mTOR inhibitor therapy in patients with metastatic breast cancer. Conditions: Everolimus, Pneumonitis Intervention / Treatment: Location: China Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: 1. Postmenopausal woman (or premenopausal women treated with LHRHa) diagnosed with HR+，HER2- metastatic breast cancer 2. Treated with everolimus for at least one month in metastatic setting 3. With baseline and at least one follow-up chest CT during everolimus therapy. 4. Complete medical history Exclusion Criteria: 1. Incomplete medical history 2. Radiographic imaging unavailable

Study Objectives All patients with a new, untreated solitary pulmonary nodule (SPN) between 7 mm and 3 cm in diameter identified by chest x-ray, will be approached to undergo positron emission tomography (PET) and computerized tomography (CT). The PET and CT scans will be interpreted independently. The Primary Care Physician will be provided the results of the baseline chest x-ray and the CT scan, and will be asked for a management and treatment decision. Then the results of the PET will be provided to the Primary Care Physician who will be asked for a management and treatment decision based on all findings (chest x-ray, CT, and PET). Conditions: Benign and Malignant Solitary Pulmonary Nodules Intervention / Treatment: PROCEDURE: PET Imaging, PROCEDURE: CT scan Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: DIAGNOSTIC Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

All patients with a new, untreated solitary pulmonary nodule (SPN) between 7 mm and 3 cm in diameter identified by chest x-ray, will be approached to participate in the study.

Study Objectives This research study is studying a combination of drugs with radiation as a possible treatment for Glioblastoma. The drugs involved in this study are: * Bavituximab * Temozolomide Conditions: Glioblastoma Intervention / Treatment: DRUG: Temozolomide, DRUG: Bavituximab, RADIATION: Radiation 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: * Participants must have histologically confirmed newly diagnosed glioblastoma or glioblastoma variant (ex. gliosarcoma), including documentation of unmutated isocitrate dehydrogenase (IDH) by immunohistochemistry (sequencing not required). * Participants must have 1-4 cm2 measurable disease (4 cm2 is the maximal size). See Section 11 for the evaluation of measurable disease. Disseminated GBM is not allowed. * No prior immunotherapy allowed or prior alkylating agents or prior radiation to the brain. * Age \>17 years since adult GBM is biologically different from pediatric GBM and there is no data for bavituximab in pediatric populations. * Karnofsky ≥60%, see Appendix A * Life expectancy of greater than 6 months. * Participants must have normal organ and marrow function as defined below: * leukocytes ≥3,000/mcL * absolute neutrophil count ≥1,500/mcL * platelets ≥100,000/mcL * total bilirubin within normal institutional limits (unless patient has Gilbert's syndrome in which total bilirubin should be ≤ 2xULN) * AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal * creatinine within normal institutional limits OR * creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal(using Cockcroft Gault Formula) * negative serum pregnancy test in WOCBP * INR/PT ≤1.5 x institutional ULN unless subject is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of intended use of anticoagulants * aPTT ≤1.5 x institutional ULN unless subject is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants * \< 4 mg dexamethasone daily (or equivalent if on another corticosteroid) at time of start of therapy. Patients on a steroid taper post-surgery and are anticipated to be on \<4 mg at time of chemoradiation initiation will be eligible to consent but to initiate treatment on trial, the participant must be on \<4 mg or equivalent of steroids otherwise participate will be deemed a screen fail and be replaced. * The effects of bavituximab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of bavituximab administration. * Able to undergo an MRI scan and receive gadolinium-based contrast. * 1 cm3 of available tissue. * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Participants who are receiving any other investigational agents. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to bavituximab. * Participants receiving any medications or substances that are moderate and/or potent enzyme inducers or inhibitors which may have an effect on the metabolism of bavituximab. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product (Appendix C for partial list). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because bavituximab is an immunotherapy agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with bavituximab breastfeeding should be discontinued if the mother is treated with bavituximab. These potential risks may also apply to other agents used in this study. * HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with bavituximab. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated. * Participants with other active malignancy in the past 3 years excluding in situ tumors. * Participants must meet the following windows from procedures (there is no window required for port placement since there is no anticipated impact on wound healing with bavituximab): * Major surgery (ex. craniotomy) within 3 weeks of initiation of treatment. * Brain biopsy within 2 weeks * Participants with history of bleeding disorder/coagulopathy. * Participants with history of chronic or acute hepatitis C or B infection

Study Objectives This is a biomedical study of interventional type. The trial will include 270 patients (180 patients in the first cohort and 90 patients in a second cohort) over a period of 3 years + 2 years of follow up. This prospective study will be conduct in patients who will receive a third line chemotherapy for metastatic breast cancer. The main objective of the study (first cohort) is to identify patients who benefit from a third line treatment in terms of overall survival with a score established from clinical, histological, but also biological "classic" and "innovative" (account of circulating tumor cells) criteria, all of these criteria must be measurable before the introduction of the 3rd line. This score will then be validated on the 2nd cohort. There will be no interruption of inclusions between first and second cohort of patients Conditions: Metastatic Breast Cancer Starting a Third Line Chemotherapy Intervention / Treatment: OTHER: Construction of a prognostic score (non-drug intervention types) Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: 1. Women of more than 18 years old 2. WHO 0-4 3. Metastatic breast cancer 4. Progression after two lines of chemotherapy with treatment decision by investigator to start a third-line chemotherapy 5. Evaluable disease 6. Histology: breast carcinoma whatever the histological type, grade, hormone receptor expression and HER-2 7. Patient able to complete the EORTC PAL 15 Questionnaire 8. Patient member in a national insurance scheme 9. Informed consent obtained and signed by the patient Exclusion Criteria: 1. History of other (s) cancer (s) potentially metastatic (s) 2. Woman participating in a third line chemotherapy clinical trial 3. Pregnant women or nursing mothers can not participate in the study 4. Patient under legal guardianship 5. Patient unable to undergo medical test for various reasons including social or psychological reasons.

Study Objectives We aim to develop an EUS-AI model which can facilitate clinical diagnosis by analyzing EUS pictures and clinical parameters of patients. Conditions: Pancreatic Ductal Adenocarcinoma, Pancreatitis, Chronic, Pancreatic Neuroendocrine Tumor, Autoimmune Pancreatitis Intervention / Treatment: DIAGNOSTIC_TEST: EUS-AI model Location: China Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Patients who underwent EUS using a curved line array echoendoscope (GF-UCT260; Olympus Medical Systems) since 2014 in our affiliation. * For each patient, all available native EUS pictures are included. * Patients' diagnosis are validated by surgical outcomes or fine-needle aspiration (FNA) findings and have a compatible clinical course with a follow-up period of more than 6 months. Exclusion Criteria: * The image is of poor quality. * The images contain unique marks which can potentially bias the model, such as the biopsy needle.

Study Objectives Blood and marrow stem cell transplant has improved the outcome for patients with high-risk hematologic malignancies. However, most patients do not have an appropriate HLA (immune type) matched sibling donor available and/or are unable to identify an acceptable unrelated HLA matched donor through the registries in a timely manner. Another option is haploidentical transplant using a partially matched family member donor. Although haploidentical transplant has proven curative in many patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including GVHD and infection due to delayed immune reconstitution. These can, in part, be due to certain white blood cells in the graft called T cells. GVHD happens when the donor T cells recognize the body tissues of the patient (the host) are different and attack these cells. Although too many T cells increase the possibility of GVHD, too few may cause the recipient's immune system to reconstitute slowly or the graft to fail to grow, leaving the patient at high-risk for significant infection. For these reasons, a primary focus for researchers is to engineer the graft to provide a T cell dose that will reduce the risk for GVHD, yet provide a sufficient number of cells to facilitate immune reconstitution and graft integrity. Building on prior institutional trials, this study will provide patients with a haploidentical graft engineered to specific T cell target values using the CliniMACS system. A reduced intensity, preparative regimen will be used in an effort to reduce regimen-related toxicity and mortality. Two groups of patients were enrolled on this study. One group included those with high-risk hematologic malignancies and the second group included participants with refractory hematologic malignancies or undergoing a second transplant. The primary aim of the study was to estimate the relapse rate in the one group of research participants with refractory hematologic malignancies or those undergoing second allogeneic transplant. Both groups will be followed and analyzed separately in regards to the secondary objectives. This study was closed to accrual on April 2006 as it met the specific safety stopping rules regarding occurrence of severe graft vs. host disease. Although this study is no longer open to accrual, the treated participants continue to be followed as directed by the protocol. Conditions: Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Juvenile Myelomonocytic Leukemia, Myelodysplastic Syndrome, Paroxysmal Nocturnal Hemoglobinuria, Hodgkin's Lymphoma, Non-Hodgkin Lymphoma Intervention / Treatment: DRUG: Systematic chemotherapy and antibodies, PROCEDURE: Allogeneic stem cell transplantation, DEVICE: Miltenyi CliniMACS 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: Eligible participants were assigned to one of two different strata dependent on diagnosis, disease status and/or past transplant experience. Both strata received the same intervention but will be followed and analyzed separately. * Group A must have one of the following diagnosis * Acute lymphoid leukemia (ALL) in second or subsequent remission or high risk in first remission * Acute myeloid leukemia (AML) in remission or with ≤ 25% blasts in bone marrow * Chronic myeloid leukemia (CML) * Juvenile myelomonocytic leukemia (JMML) * Myelodysplastic syndrome (MDS) * Paroxysmal nocturnal hemoglobinuria (PNH) * Hodgkin's (HD) or non-Hodgkin's lymphoma (NHL) in second or subsequent remission after autologous HSCT, or unable to have hematopoietic stem cells collected for autologous HSCT * Group B must have one of the following refractory diagnosis (chemoresistant relapse or primary induction failure) * Acute lymphoid leukemia (ALL) * Acute myeloid leukemia (AML) ≥ 25% blast in bone marrow * Secondary AML / MDS * Chronic myeloid leukemia (CML) in accelerated phase or blast crisis * Juvenile myelomonocytic leukemia (JMML) * Myelodysplastic syndrome (MDS) * Hodgkin's (HD) or non-Hodgkin's lymphoma (NHL) with residual disease followed by autologous HSCT or who have chemo-resistant disease * Or patients who have undergone prior allogeneic HSCT or who have a co-morbid condition that in the medical opinion of the Transplant Faculty makes standard myeloablation prohibited * At least 2 and less than or equal to 21 years of age * Lacks suitable HLA-identical sibling or matched available unrelated donor and has a mismatched family member donor that is available, HIV negative and at least 18 years old * Cardiac shortening fraction ≥ 25% * Creatinine clearance ≥ 40 cc/min/1.73m\^2 * FVC ≥ 40% of predicted or pulse oximetry ≥ 92% on room air * Direct bilirubin ≤ 3 mg/dL or SGPT ≤ 500 U/L * Karnofsky or Lansky (age dependent) performance score of ≥ 50 Exclusion Criteria: * Known allergy to murine products * Lactating (female patient) * Pregnancy (female patient) * Active central nervous system (CNS) leukemia

Study Objectives Purpose:To gather preliminary data and to determine the feasibility and acceptability of an 8-week Tai Chi intervention for adults cancer survivors (survivors) who report experiencing cognitive impairment, and to perform exploratory analyses to assess improvements in cognitive performance, health-related quality of life, brain activity, and blood-based biomarkers. Participants: Adult survivors (\> 18 years old) who report experiencing cognitive impairment and are within 60 months of completion of chemotherapy for treatment of a breast cancer diagnosis. Procedures (methods): A single arm pre-/post-test non-randomized study design in adult cancer survivors (Enrollment goal N=15; current age ≥ 18 years, treatment completed within 60 months). Outcomes will be assessed at baseline and after the 8-week Tai Chi intervention, and consist of feasibility, acceptability, expectancy/credibility, health-related quality of life, cognitive performance, serum biomarkers, and brain activity. Conditions: Cancer, Breast, Cognitive Impairment Intervention / Treatment: BEHAVIORAL: Tai Chi Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Was diagnosed with breast cancer (all stages accepted). * Currently \> 18 years of age * Age at cancer diagnosis \> 18 years. * Able to engage in moderate intensity exercise as determined by their treating physician. If participant no longer has a treating physician, safety will be determined by following the American College of Sports Medicine (PAR-Q \& YOU) physical activity questionnaire. An answer of "yes" to \> one of the seven questions will require the participant to receive written permission from their physician prior to beginning the Tai Chi intervention. * Not previously engaged in regular exercise training (\>1-2d/wk for \>30 min/d) in past 6 months. * Completed chemotherapy treatment for a breast cancer diagnosis. * Cancer chemotherapy treatment completed within last 60 months. Defined as not currently scheduled for or undergoing active treatment (chemotherapy, radiation, surgery). Treatments to prevent or delay recurrence (e.g., breast cancer hormonal therapies) or for maintenance of remission are allowed. * Report experiencing cognitive impairment following treatment for cancer. * No psychiatric disorder with psychotic features. * Able to receive emails from study staff (i.e. for receiving study reminders). * Able to speak and read English. * Able to provide informed consent. Exclusion Criteria: * Unwilling or unable to complete study procedures. * Currently participating in another study which would preclude participation in this study. * Has a known additional malignancy that is metastatic, progressing, or requires active treatment. * Has a neurocognitive disorder of other etiologies, such as Alzheimer's Parkinson's, etc., that might confound the analysis

Study Objectives This study was to evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML. Conditions: Refractory Leukemia, Acute Myelogenous Leukemia Intervention / Treatment: DRUG: Panobinostat/LBH589 Location: Korea, Republic of, Belgium, Turkey, Germany, United States, Australia, Spain, France, Switzerland, United Kingdom, Italy, Peru Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Written informed consent prior to study-specific screening procedures * Life expectancy of ≥ 60 days * Eastern Cooperative Group (ECOG) performance status ≤ 2 * Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR- Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD) * Negative serum pregnancy test (within 7 days of first dose) * Negative urine pregnancy test immediately prior to first dose Exclusion Criteria: * Known HIV * Psychiatric disorder that interfered with ability to understand the study and give informed consent, and/or would impact study participation or follow-up * Concurrent use of medications that might prolong the QT interval or of inducing Torsade de Pointes * Female patients who were pregnant or breast-feeding or patients of childbearing potential who were not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug. * Male patients whose sexual partner(s) were women of childbearing potential who were not willing to use a double method of contraception, one of which included a condom, during the study and for 3 months after the end of treatment * Patient unable to swallow capsules * Patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat Other Protocol-defined inclusion/exclusion criteria may apply

Study Objectives RATIONALE: Comparing lung CT scans from participants with lung nodules at high-risk for lung cancer may help doctors learn more about the disease and find better methods of treatment. PURPOSE: This trial studies the natural history of lung nodules using CT scans from participants at high-risk for lung cancer. Conditions: Lung Cancer, Precancerous Condition Intervention / Treatment: OTHER: medical chart review, PROCEDURE: computed tomography, PROCEDURE: computer-aided detection/diagnosis Location: Italy Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: * Annual Computed Tomography (CT) scans obtained from participants with undetermined lung nodules detected by low-dose CT enrolled in both of the following trials: * A large-scale COSMOS screening trial * Three annual CT scans obtained as part of the COSMOS trial after budesonide study treatment completion * The MDA05-5-01, a subset of COSMOS trial participants, a randomized phase II trial of inhaled budesonide twice daily versus placebo * Two CT scans performed as part of the budesonide protocol (MDA05-5-01) * Only CT scans from participants enrolled in both trials will be used PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Study Objectives This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early breast cancer (EBC) whose primary tumors were greater than or equal to (\>/=) 2 centimeters (cm). The study was designed to evaluate the efficacy and safety of trastuzumab emtansine + pertuzumab (experimental arm; T-DM1 + P) versus chemotherapy, trastuzumab + pertuzumab (control arm; TCH + P). The study comprised a neoadjuvant treatment period, followed by surgery, and an adjuvant treatment period. Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination. Conditions: Breast Neoplasms Intervention / Treatment: DRUG: Carboplatin, DRUG: Docetaxel, DRUG: Pertuzumab, DRUG: Trastuzumab, DRUG: Trastuzumab Emtansine Location: Taiwan, Ukraine, Korea, Republic of, Belgium, Germany, United States, Canada, Spain, France, Russian Federation Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed invasive breast cancer with a primary tumor size of greater than (\>) 2 cm * HER2-positive breast cancer * Participants with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) are eligible provided all discrete lesions are sampled and centrally confirmed as HER2 positive * Stage at presentation: cT2-cT4, cN0-cN3, cM0, according to American Joint Committee on Cancer (AJCC) staging system * Known hormone receptor status of the primary tumor * Participant agreement to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Baseline Left Ventricular Ejection Fraction (LVEF) \>/= 55 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) * Effective contraception as defined by protocol Exclusion Criteria: * Stage IV (metastatic) breast cancer * Participants who have received prior anti-cancer therapy for breast cancer except those participants with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated exclusively with mastectomy. In case of prior history of LCIS/DCIS, \>5 years must have passed from surgery until diagnosis of current breast cancer * Participants with multicentric (multiple tumors involving more than 1 quadrant) or bilateral breast cancer * Participants who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes * Axillary lymph node dissection or positive sentinel lymph node prior to start of neoadjuvant therapy * History of concurrent or previously non-breast malignancies except for appropriately treated (1) non-melanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease-free \>/= 5 years * Treatment with any investigational drug within 28 days prior to randomization * Current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0 * Any significant concurrent medical or surgical conditions or findings that would jeopardize the participant's safety or ability to complete the study * Current pregnancy or breastfeeding

Study Objectives The main aim of the study is to assess if a pre consultation intervention facilitates greater participation of patients (and accompanying key persons when present) in the consultation process by determining an increase in questioning and/or in the number of different illness related issues (e.g. diagnosis, treatment, prognosis) being discussed with the oncologist. Other aims are to assess the effect of the intervention on the oncologist's level of patient involvement, on patient satisfaction and coping and to explore the role of key persons accompanying the patient. The investigators expect that patients who have the opportunity to rehearse their informative needs before the consultation will ask a greater number of questions which in turn will determine their greater involvement by the physician and a greater number of satisfied needs. The investigators expect also that the straightforward use of a list of printed questions of potential relevance for cancer patients and their companions at an early stage of illness, by modifying the process of information exchange, increases their participation and satisfaction with the consultation, with potential benefits for treatment adherence and consequently treatment efficacy. Conditions: Breast Cancer Intervention / Treatment: BEHAVIORAL: prompt-sheet, BEHAVIORAL: control group Location: Italy Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * all consecutive patients * age between 18 and 75 years * attending the Oncology Out-patient Clinics of the participating centres * recent diagnosis of breast cancer at an early stage Exclusion Criteria: * presence of metastasis or relapse * severe mental deterioration * comprehension difficulties of the Italian language.

Study Objectives This is a Phase II study of the drug combination of Oxaliplatin, Avastin and capecitabine. This is an open-label study. Conditions: Cancer Intervention / Treatment: DRUG: Bevacizumab, DRUG: Capecitabine, DRUG: Oxaliplatin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * advanced, surgically unresectable CRC * measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension(histological confirmation of adenocarcinoma of the colon or rectum. ECOG performance status of 0, 1, or 2 Estimated life expectancy of at least 12 weeks. * chemotherapy prior to the diagnosis of metastatic disease. The chemotherapy regimen must not have included oxaliplatin or bevacizumab. No prior therapy for metastatic disease is permitted. * Evidence of adequate organ function, including: * Evidence of adequate hepatic function, * Evidence of adequate renal function INR \<1.5 x ULN (unless taking warfarin in which case it must be in the therapeutic range). Patients on warfarin are allowed to participate. * Absence of proteinuria on urine analysis· Patients with a history of prior non-colorectal malignancies are eligible if they have been disease-free for at least 5 years prior to study entry and are deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: melanoma in situ, and basal cell and squamous cell carcinoma of the skin. * Age \> 18 yrs. Exclusion Criteria: * Any systemic therapy administered for metastatic or locally recurrent disease. Patients who are considered candidates for surgical resection of metastatic and/or locally advanced disease. * Any histology other than adenocarcinoma of the colon or rectum. * Pregnancy or lactation at the time of patient entry or women of childbearing potential with no pregnancy test. Eligible patients of reproductive potential (both sexes) must agree to use adequate contraceptive methods during and for 6 months after study therapy. * Serious concomitant medical conditions that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study. * General Medical Concerns History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications. * Serious, uncontrolled, concurrent infection. * Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations or core biopsies within 7 days prior to Day 0. * Proteinuria at baseline or clinically significant impairment of renal function. * Serious, non healing wound, ulcer, or bone fracture * Subjects who can not take oral medication

Study Objectives Isocapnic hyperventilation (IHV) is a method that shortens time to extubation after inhalation anaesthesia by increasing airway carbon dioxide (CO2) during hyperventilation (HV). In two experimental studies (mechanical lung model and porcine model) and in a pilot study on patients undergoing sevoflurane anaesthesia for major ear-nose-throat (ENT) surgery, the investigators evaluated the feasibility of an alternative technique of IHV. By performing a prospective, randomised controlled study, the investigators want to further test this alternative method for IHV. Conditions: Oropharyngeal Neoplasms Intervention / Treatment: DEVICE: Isocapnic hyperventilation Location: Sweden Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: OTHER Allocation: RANDOMIZED Interventional Model: SEQUENTIAL Masking: NONE

Inclusion Criteria: * Adult patients scheduled for major elective ear-nose-throat (ENT) surgery after informed consent was obtained during the pre-operative evaluation. Exclusion Criteria: * Patients with severe pulmonary or circulatory disease

Study Objectives The purpose of this study is to determine whether the application of low dose total body irradiation following chemo-immuntherapy in elderly patients with aggressive with non-Hodgkin's lymphoma would be safe and potentially benecicial adjuvant therapy Conditions: Non Hodgkin's Lymphoma Intervention / Treatment: RADIATION: Low dose total body irradiation Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * previously untreated, pathology verified aggressive non-Hodgkin lymphoma of the diffuse large B-cell type according to the WHO classification. Age between 60 years and 80 years.Positive for an anti-CD20 antibody. Good performance status and normal initial normal blood count. Exclusion Criteria: * Patients with previous lymphoma associated with immune suppression of any sort. Diagnosis or history of indolent lymphoma or other malignancies. Marked impairment of any vital organ such as the heart, lung, liver or kidneys.

Study Objectives RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy works in treating patients with acute promyelocytic leukemia. Conditions: Leukemia Intervention / Treatment: DRUG: arsenic trioxide, DRUG: cytarabine, DRUG: daunorubicin hydrochloride, DRUG: mercaptopurine, DRUG: methotrexate, DRUG: tretinoin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: * Diagnosis of acute promyelocytic leukemia (APL) by morphologic and flow cytometric documentation (high orthogonal light scatter, lack of HLA-DR expression) * Patients with classical APL as well as the microgranular variant (M3V) are eligible * In cases where the diagnosis is unclear, consultation with a hematopathologist is required before enrolling the patient in the study * Patients found to have cytogenetic abnormalities that do not produce the PML-RARα gene rearrangement will be removed from study and will not be included in data analysis PATIENT CHARACTERISTICS: * Patients will not be excluded because of performance status or comorbid disease * Premenopausal female patients must have a negative pregnancy test PRIOR CONCURRENT THERAPY: * No prior chemotherapy for APL except hydroxyurea

Study Objectives Chemotherapy-induced thrombocytopenia (CIT) is a common hematological toxicity in patients with solid tumors undergo chemotherapy, which can increase the risk of bleeding, prolong hospital stay, increase medical costs, and even lead to death in severe cases. The incidence and severity of CIT varies among different chemotherapy regimens. Recombinant human interleukin-11 (rhIL-11) and recombinant human thrombopoietin (rhTPO) have been approved for the treatment of chemotherapy-induced thrombocytopenia. Tumor patients are at high risk for venous thromboembolism (VTE). In the clinical study of rhIL-11, it was found that the administration of rhIL-11 in healthy subjects caused an increase in the plasma concentration of vWF factor in the form of normal mults. The application of rhIL-11 in patients with myeloid leukemia can increase the concentration of α2 globulin, fibrinogen and prothrombin time. However, there have been no large-scale clinical studies at home and abroad to evaluate whether platelet raising therapy will increase the risk of thrombosis in chemotherapy patients with solid tumor. This study is aimed to evaluate the efficacy and safety of platelet upwelling therapy in patients with solid tumors undergoing chemotherapy. Conditions: Chemotherapy-induced Thrombocytopenia Intervention / Treatment: DRUG: Recombinant Human Interleukin-11 for Injection Location: China Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Patients with pathological diagnosis of solid tumors or lymphomas. * Have received chemotherapy. * Diagnosed of CIT. * Continuous use of platelet raising drugs for at least 5 days. Exclusion Criteria: * Thrombocytopenia caused other than chemotherapy, including but not limited to: traditional Chinese medicine, congenital platelet disease, etc. * The basic value of platelet count is continuously higher than 300×10\^9/L. * Those without blood routine or coagulation function data. * Those who received non-chemotherapy drugs that may cause thrombocytopenia, such as sulfonamides. * Pseudothrombocytopenia due to Ethylenediamine tetraacetic acid (EDTA) as an anticoagulant in test samples.

Study Objectives The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules of single-agent Irinotecan in women with metastatic breast cancer who have experienced failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3 week cycles. Conditions: Breast Neoplasms Intervention / Treatment: DRUG: Irinotecan Location: Argentina, New Zealand, United States, Australia, Colombia Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Women with diagnosis of primary adenocarcinoma of the breast * Presence of locally advanced or metastatic disease non-amenable to surgery or radiation therapy with curative intent * At least one measurable lesion \>20mm (or \>10 mm with spiral CT scan) * Must have received (and failed) prior treatment with an anthracycline, a taxane, and capecitabine in the adjuvant and/or advanced disease treatment setting * Women at least 18 years old, with performance status 0-2 Exclusion Criteria: * Prior treatment with another topoisomerase I inhibitor * Current enrollment in another clinical trial

Study Objectives The study will evaluate the incidence of major bleeding (including clinically relevant non-major (CRNM) bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg twice a day (BID) compared to current standard of care, subcutaneous enoxaparin 40 mg once a day (QD) for 28 days post surgery. Conditions: Gynecologic Cancer, Venous Thromboembolism Intervention / Treatment: DRUG: Oral apixaban, DRUG: Subcutaneous enoxaparin Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Suitable candidate for surgery (meets appropriate performance status, no significant cardiac/renal/hepatic dysfunction * Diagnosis of pelvic malignancy (suspected/confirmed ovarian, endometrial/uterine, cervical cancers, and vulvar cancers) undergoing surgical debulking, * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to surgery, * Women must not be breastfeeding, WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) apixaban plus 5 half-lives of study drug apixaban (2.5 days) plus 30 days (duration of ovulatory cycle) for a total of 32.5 days post-treatment completion. Exclusion Criteria: * Malignancy or mass that is non-gynecologic in origin (mass/tumor of origin other than reproductive organ such as rectal, abdominal, breast) * Positive pregnancy test on day of surgery, * Known history of Venous (Thromboembolism) VTE prior to diagnosis (DVT or Pulmonary Embolism (PE)) due to increased underlying risk of new event * Concomitant NSAIDS or other anticoagulant/antiplatelet therapy including Acetylsalicylic Acid (Aspirin) (ASA) \>81mg/day, * Selective serotonin re uptake inhibitor (SSRIs) and Serotonin-nor-epinephrine re uptake inhibitor (SNRIs) (common anti-depressant therapies), * Uncontrolled severe hypertension (systolic \>200 mmHg or diastolic \>120 mmHg), * With prosthetic heart valves, * Active bleeding condition (not limited to: thrombocytopenia, haemophilias, potential bleeding lesions, recent trauma or surgery, recent stroke, confirmed intracranial or intraspinal bleeding), * Known or documented bleeding disorders not limited to: anti-phospholipid syndrome, homozygotes for Factor V Leiden deficiency, antithrombin III deficiency, protein C deficiency, Protein S deficiency, hyperhomocysteinemia, systemic lupus erythematous, or Prothrombin G2020 gene mutation, * Significant renal disease as defined by creatinine clearance less than 30 mL/min, * Significant liver disease as defined as Aspartate Transaminase (AST) or Alanine Transaminase (ALT) twice than normal, * Concomitant use of dual strong inhibitors or inducers (CYP3A4, P-gp) * Protein C deficiency (increased risk of skin necrosis do those on injectable anticoagulation), * Documented allergy to apixaban and/or enoxaparin, * Patient's deemed otherwise clinically unfit for clinical trial per Investigator's discretion

Study Objectives This pilot clinical trial studies magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy (SBRT) in treating patients with liver metastases or liver cancer. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Combining MRI with SBRT may help doctors to highlight the tissues surrounding the tumor better. Conditions: Adult Hepatocellular Carcinoma, Metastatic Malignant Neoplasm in the Liver Intervention / Treatment: RADIATION: Image-Guided Adaptive Radiation Therapy, RADIATION: Stereotactic Body Radiation Therapy Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Patients may have either metastatic lesions from another primary site or primary hepatocellular carcinoma; patients with one histologically confirmed metastatic lesion of the liver who are presenting for local therapy for lesions concerning for metastases that cannot or should not be biopsied will also be considered for enrollment on a case by case basis; patients can simultaneously receive treatment for multiple hepatic lesions meeting the prior two requirements, at the discretion of the treating radiation oncologist * Karnofsky performance status (KPS) \>= 70 * No active infections requiring systemic antibiotics * If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study * Ability to understand and willingness to sign a written informed consent Exclusion Criteria: * Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study * Refusal to sign the informed consent * Patients who are participating in a concurrent treatment protocol * Patients for whom a plan meeting institutional quality criteria cannot be designed for SBRT treatment via the MRI-guided teletherapy unit, but for whom an SBRT plan meeting institutional quality criteria can be designed for a conventional linear accelerator

Study Objectives Postoperative recurrent pilonidal sinus disease is troublesome and its treatment is challenge. Many treatment modalities have been advocated in the treatment of recurrent pilonidal sinus disease; however, there is still no consensus in the literature. Some minimally invasive techniques are used alone or as an adjunct to surgery. Crystallized phenol is the most popular method in the nonoperative treatment of primer pilonidal sinus disease. But its long term effect in the postoperative recurrent cases is unclear. Investigators aimed to present the long-term efficacy of crystallized phenol treatment on postoperative recurrent pilonidal sinus disease through our results collected within the last 20 years. Conditions: Pilonidal Sinus Intervention / Treatment: PROCEDURE: Crystallized phenol treatment Location: Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Previous operated recurrent pilonidal sinus disease * Follow-up period of more than 12 months * The patients who connection by e-mail or telephone Exclusion Criteria: * Primer pilonidal sinus disease * Follow-up period of less than 12 months * The patients who can't connection by e-mail or telephone

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 combination chemotherapy in treating patients with locally advanced or metastatic solid tumors. Conditions: Unspecified Adult Solid Tumor, Protocol Specific Intervention / Treatment: DRUG: cisplatin, DRUG: irinotecan hydrochloride, DRUG: paclitaxel Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: Interventional Model: Masking:

DISEASE CHARACTERISTICS: Histologically proven locally advanced (unresectable or recurrent) or metastatic solid tumor No bone metastases, abnormal radionuclide bone scan or pleural effusions as the sole indicators of disease No CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present) No Gilbert's Disease Renal: Creatinine no greater than 1.5 mg/dL Serum calcium less than 12.0 mg/dL No symptomatic hypercalcemia Cardiovascular: No unstable angina No active angina No New York Heart Association class III or IV heart disease No uncontrolled asymptomatic congestive cardiac failure At least 6 months since any myocardial infarction Pulmonary: No interstitial pulmonary fibrosis Other: No history of seizure disorder and receiving phenytoin, phenobarbital, or other antiepileptic medication No active or uncontrolled infection No uncontrolled diabetes mellitus Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: One prior chemotherapy regimen allowed Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior mantle, hemibody, pelvic, or lumbar spine irradiation Surgery: Not specified

Study Objectives This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, naive and non-naive of HER2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with Herceptin SC in routine clinical practice use are eligible to participate. The total study duration is anticipated to be 38 months. Conditions: Breast Cancer Intervention / Treatment: Location: France Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Aged \>/= 18 years * Patients with HER2-positive early breast cancer who according to national guidelines are eligible for neoadjuvant or adjuvant HER2+ treatment * Patients for whom the investigator has decided to start a treatment with Herceptin SC * Trastuzumab treatment naive or non-naive (previously intravenous treatment) * Informed consent Exclusion Criteria: * Patients previously treated with Herceptin SC treatment

Study Objectives This is a randomized, double-blind, controlled, parallel-cohort Phase II clinical study, which is planned to enroll 220 subjects with advanced cervical cancer who have failed or cannot tolerate first-line or above platinum-based chemotherapy Conditions: Advanced Cervical Cancer Intervention / Treatment: DRUG: IBI310, DRUG: Placebo, DRUG: Sintilimab Location: China Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: 1. The subject must sign the written informed consent form, and can comply with the visits and related procedures specified in the protocol. 2. Aged ≥18 years and ≤75 years. 3. Diagnosed with cervical cancer by histology/cytology. 4. Patients with relapsed or metastatic cervical cancer who have had progressed or relapsed after receiving at least first-line of platinum-based chemotherapy (if a patient has progressed or relapsed during or within 6 months after receiving platinum-based neoadjuvant or adjuvant chemotherapy, she will be deemed to have received first-line treatment). 5. The subject's previous systemic treatment must have ended ≥4 weeks before the first study administration, and the treatment-related AEs have recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 grade ≤1 (except for alopecia and fatigue). Exclusion Criteria: 1. Diagnosis of other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, radically resected carcinoma in situ and/or thyroid papillary carcinoma. 2. Pleural effusion, ascites, and pericardial effusion with clinical symptoms or requiring drainage (patients with effusion that does not require drainage or patients with no significant increase in the effusion within 3 days after stopping drainage can be selected). 3. Patients who are planning to undergo or have previously received organ or bone marrow transplantation. 4. Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA\> 200 IU/ml or 103 copies/ml; hepatitis C virus (HCV) antibody positive and HCV-RNA level higher than the lower limit of detection. Patients with acute or chronic active hepatitis B or C infection who have received nucleotide antiviral therapy and are below the above standards can be selected. 5. Meningeal metastases or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic brain metastases who do not need treatment with glucocorticoids, anticonvulsants or mannitol after radiotherapy can be enrolled.

Study Objectives RATIONALE: 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 more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy, with or without chemotherapy, with chemotherapy alone in treating patients with stage I or stage IIA Hodgkin's disease. Conditions: Hodgkin Lymphoma Intervention / Treatment: BIOLOGICAL: bleomycin sulfate, DRUG: dacarbazine, DRUG: doxorubicin hydrochloride, DRUG: vinblastine, RADIATION: radiation therapy Location: Canada, Italy, United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Eligibility Criteria * Histologically proven Hodgkin's Disease. A needle aspirate specimen will not be considered sufficient for diagnosis. * Pathologic material must have been reviewed by a designated local reference pathologist (LRP) prior to randomization. Histologic subtype determined by the LRP will be used for patient cohort assignment. * Patients must have clinical stage I - IIA disease according to Ann Arbor staging criteria. Clinical stage must be based on at least one tissue biopsy. The following aspects are to be considered in determining patient stage: i) Splenic Enlargement: Splenic enlargement determined by imaging studies only should not be considered evidence of splenic involvement with Hodgkin's disease. Patients should be considered as having splenic involvement if the spleen is palpable on physical examination and enlarged on imaging studies, or imaging studies show focal abnormalities consistent with Hodgkin's disease. These patients, if presenting with supradiaphragmatic disease would therefore be assessed as having Stage III disease and would be ineligible. ii) Bone Disease: Lytic or blastic lesions seen on plain radiographs or abnormalities on bone scan consistent with Hodgkin's disease will be considered as bone involvement with Hodgkin's disease. These patients would therefore be assessed as having Stage IV disease and would be ineligible. iii) Pleural Effusion and Ascites: The presence of a pleural effusion or ascites will be considered as evidence of Hodgkin's disease even if cytological examination is negative. These patients would be assessed as having probable Stage IV disease and therefore would be ineligible. Patients assessed on Xray as having pleural thickening or "blunting" of the costophrenic angle only may be eligible. iv) Extra-nodal vs. Stage IV Disease: Patients with disease involving a single extra-nodal site may be considered as "limited-stage" provided all disease can be included in a standard radiation field. Patients with extra-nodal disease that cannot be included in such a field (eg, lung, bone) or with multiple sites of extra-nodal disease are not eligible for this trial. * Pulmonary function tests must be done in patients with symptomatic lung disease. FVC, FEV-1 and DLCO must be ≥ 60% of predicted value. Patients with asthma controlled by medication are eligible if the above criteria are met. * Patient's age is ≥ 16 years. (Note that the lower age limit at each centre will be determined by that centre's policy regarding the age at which an individual may sign their own consent.) * Patient must not have received previous chemotherapy or radiotherapy. * Laboratory requirements: granulocytes ≥ 1.5 x 109/L (S.I.) or ≥ 1.5 x 103/uL (U.S.) platelets ≥ 125 x 109/L (S.I.) or ≥ 125 x 103/uL (U.S.) bilirubin ≤ 2.5 x UNL (unless due to hemolytic anemia) serum creatinine ≤ 2 x UNL * Patient must have been seen by both a radiation oncologist and medical oncologist who agree the patient is able to receive protocol radiation therapy. * Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Clinical Trials Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is given. The patient must sign the consent form prior to randomization. Please note that the consent form for this study must contain a statement which gives permission for the NCICCTG and monitoring agencies to review patient records. * Availability of patient for follow-up and quality of life (QoL) assessments. Patients must be accessible for treatment and follow-up. Investigators must assure themselves that patients registered on this trial will be available for complete documentation of the treatment, toxicity and follow-up. Comparison of quality of life is an end-point of this study. Patients must have completed the pre-randomization quality of life assessment and be willing to complete future assessments. The only exceptions will be patients who are unable to read english or french. Patients on study are expected to complete all the quality of life assessments but, should this not prove possible, they will be retained in the study for all other analyses. Ineligibility Criteria * Prior or concurrent malignancies, except adequately treated basal cell carcinoma of the skin. (Patients with prior carcinoma-in-situ of the cervix are not eligible.) * Cardiac disease defined as symptomatic congestive heart failure or coronary artery disease, known valvular (other than asymptomatic mitral valve prolapse) or congenital heart disease (other than asymptomatic atrial septal defects) or need for cardiac medications. Hypertension controlled with drug therapy is not an exclusion criterion. * Other major medical illness judged likely by the local investigator to preclude safe administration of protocol treatment or required follow-up. * Patients with stage IA disease (who might be treated with involved-field only irradiation) defined by meeting all of the following criteria: i) lymphocyte predominant or nodular sclerosing histology ii) disease bulk \< 3 cm iii) erythrocyte sedimentation rate (ESR) \< 50 iv) unilateral high - neck only disease, defined as disease located above the upper border of the thyroid cartilage or isolated epitrochlear adenopathy * Patients with very unfavourable clinical stage I-IIA disease defined as bulky adenopathy. Bulky adenopathy is defined as a palpable nodal mass greater than 10 cm. in diameter or a mediastinal mass with a maximum mass diameter measuring greater than or equal to 1/3 the maximum chest wall diameter (see Appendix III). * Patients with intra-abdominal disease. (Patients with pelvic disease: ileofemoral, inguinal or parailiac nodes are eligible for this study.) * Patients with B symptoms. * Patients known to have a positive antibody test for the human immunodeficiency virus (HIV) or who have a clinical diagnosis of acquired immunodeficiency syndrome. HIV testing is not a requirement for study entry. * Patients who have undergone a staging laparotomy. * Female patients who are pregnant. Note: men and women of childbearing age must be advised in the use of adequate contraception.

Study Objectives The investigators recruited 1542 Breast Cancer (BC) patients and to randomize the participants in two groups: 773 have received standard recommendations for healthy lifestyle without, however, any active support; 700 have received a combination of individual and group contacts over the course of one year, including kitchen courses, gym and dance classes, common meals and reinforcing meetings, with emphasis on a comprehensive dietary change including low saturated fat and low refined carbohydrates, and high whole grain cereals and pulses consumption. Compliance have been monitored through weight change and plasma glucose, triglycerides, cholesterol and testosterone. The main analysis will be by intention to treat. Under the hypothesis of reducing recurrence rate by 25% or 33% the statistical power of the study is 80% or, respectively, 90%, (P\<0.05, 5-year follow-up). Conditions: Breast Cancer Invasive Intervention / Treatment: BEHAVIORAL: Intervention group on diet and physical activity, BEHAVIORAL: Control group: only public recommendation an lifestyle Location: Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Mastectomy or conservative surgery for invasive breast cancer, any type, in the last five years (the investigators recruited mostly patients at the time or after surgery, when chemotherapy has been concluded and hormonal therapy, if necessary, has been started) * Absence of signs or symptoms suggestive of recurrences * Presence of one or more of the following endocrine/metabolic indicators: serum testosterone level ≥ 0.4 ng/ml (1 nmol/ml), corresponding to the median value in BC patients, or serum insulin ≥ 50 pmol/L, corresponding to the upper quartile of insulin distribution in Breast Cancer patients, or metabolic syndrome, present in about 15% of Breast Cancer patients. Exclusion Criteria: * Metastatic disease or previous relapse * Age \>70 * Physical or mental handicaps that would have impeded to engage in moderate physical activity or participate in kitchen classes

Study Objectives The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy. Conditions: Erectile Dysfunction, Prostate Cancer Intervention / Treatment: DRUG: Tacrolimus, DRUG: Placebo Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE4 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Male scheduled to undergo bilateral nerve sparing radical prostatectomy for prostate cancer. Exclusion Criteria: * Patient is \> 65 years of age * Patient has been diagnosed with Type 1 or Type 2 diabetes * Patient is actively smoking on a daily basis

Study Objectives The aim of this study was to investigate whether NETs markers can enhance predict portal vein tumor thrombosis in patients with live cirrhosis, so as to establish a novel predictor to guide clinical decision-making. Conditions: Neutrophil Extracellular Trap Formation, Portal Vein Tumor Thrombosis Intervention / Treatment: OTHER: test NETs markers Location: China Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: （1) Clinical diagnosis of HCC with liver cirhosis (2) Clinical diagnosis of portal vein tumor thrombosis Exclusion Criteria: (1) secondary liver malignancy (2)hematologic diseases (3) Bud-Chiah syndrome (4) incomplete data

Study Objectives The purpose of this study is to learn whether 3 tesla (3T) MRI functional imaging will map a tumor more accurately allowing a more targeted delivery of radiation. The investigators hope to learn whether tomotherapy will be able to deliver higher radiation doses safely to the tumor while sparing the surrounding normal tissue. Conditions: Glioblastoma, Glioma Intervention / Treatment: PROCEDURE: Functional MRI imaging and tomotherapy Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histologically confirmed glioblastoma multiforme * Ages 18-65 * Karnofsky Performance Scale (KPS) equal to or less than 70 * Minimal neurological deficit * Eligible for concurrent temozolomide chemotherapy Exclusion Criteria: * Prior radiation therapy to hand or neck area, chemotherapy, or radiosensitizer

Study Objectives This study investigates whether risk criteria based on MRI features could identify a cohort of patients with a good prognosis among those recommended for preoperative treatment by NCCN guidelines to avoid preoperative treatment with the likely good survival outcomes by primary surgery and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatmen than radiographic TNM staging in the patients who received neoadjuvant therapy. Conditions: Rectal Cancer Intervention / Treatment: PROCEDURE: total mesorectal excision Location: China Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: 1. Underwent primary rectal adenocarcinoma resection 2. Received MRI scan before surgery 3. Willing and able to provide written informed consent for participation in this study. 4. Treatment-naive patients with histological or cytological documentation of rectal adenocarcinoma (\<12 cm from the anal verge). 5. Clinical stage of T3Nx or T1-3N+ at initial diagnosis 6. Non-complicated primary tumor (complete obstruction, perforation, bleeding). 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: 1. Treated with transanal local excision 2. with distant metastases at the time of initial diagnosis 3. Subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer. 4. Subjects with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), myocardial infarction (MI), Transient Ischemic Attacks (TIA), or cerebralvascular accident (CVA).

Study Objectives The purpose of this study is to determine the ability of a specific imaging method, termed Diffuse Optical Spectroscopic Imaging, to provide metabolic and functional information which can be used to predict overall response to preoperative (neoadjuvant) chemotherapy in patients with sarcomas. Sarcoma patients face comparatively poor response rates to chemotherapy and early, non-invasive indications of response could provide physicians with the information necessary to make evidence-based changes in treatment strategies. Patients who do not demonstrate early signs of response would be spared the unnecessary side-effects of an ineffective chemotherapy regimen, and could either be switched to a different regimen or undergo surgery Conditions: Sarcoma Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Any subjects with no current or previous history of sarcoma are eligible to be a normal volunteer * Any subject with a sarcoma neoplasm is eligible to be measured for aim 2 of the study * Only patients undergoing neoadjuvant chemotherapy for sarcoma are eligible for Aim 3 of the study Exclusion Criteria: * Age less that 18 year old

Study Objectives RATIONALE: Drugs used in chemotherapy, such as laromustine, daunorubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of laromustine when given together with daunorubicin and cytarabine in treating patients with acute myeloid leukemia. Conditions: Leukemia Intervention / Treatment: DRUG: amsacrine, DRUG: busulfan, DRUG: cytarabine, DRUG: daunorubicin hydrochloride, DRUG: laromustine, DRUG: melphalan, DRUG: mitoxantrone hydrochloride, PROCEDURE: allogeneic hematopoietic stem cell transplantation, PROCEDURE: autologous hematopoietic stem cell transplantation Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: Masking: NONE

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) * Untreated disease * No promyelocytic AML * Unfavorable prognosis, defined as at least one of the following: * Cytogenetic abnormalities including -5/5q-, -7/7q-, 3q, 11q23, t(6;9), and complex abnormalities (≥ 3 clonal abnormalities), excluding t(9;11) * Baseline hyperleukocytosis ≥ 100 g/L or progression of leukocytosis or extra-medullary localizations despite treatment with hydroxyurea * No AML with favorable or intermediate prognosis * No AML secondary to myelodysplastic syndrome diagnosed within the past 3 months or myeloproliferative syndrome PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Total bilirubin \< 35 μmol/L * Transaminases \< 2.5 times upper limit of normal in the absence of leukemia-related abnormalities * Creatinine \< 170 μmol/L OR creatinine clearance ≥ 50 mL/min in the absence of leukemia-related abnormalities * Not pregnant or nursing * Normal cardiac function by LVEF (echographic ≥ 40% or isotopic ≥ 50%) * Affiliated with a social security system * No uncontrolled or severe cardiovascular disease, including any of the following: * Myocardial infarction within the past 3 months * Cardiac insufficiency * Uncontrolled arrhythmia * No other active cancer within the past year except for basal cell carcinoma of the skin or epithelioma in situ of the cervix * No patients deprived of freedom or under guardianship (including temporary guardianship) * No psychological, familial, geographical, or social situations that preclude follow-up * No other contraindications to study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior hydroxyurea allowed * No concurrent disulfiram * No concurrent participation in another study with an experimental drug

Study Objectives RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy with or without amifostine in treating patients with recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's disease who are undergoing autologous stem cell transplantation. Conditions: Lymphoma Intervention / Treatment: DRUG: Amifostine, DRUG: DHAP Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's disease requiring salvage chemotherapy Prior treatment with at least 3 courses of first line chemotherapy PATIENT CHARACTERISTICS: Age: Over 18 Performance Status: ECOG 0-2 Life Expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 50,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 40 mL/min Cardiovascular: No symptomatic congestive heart failure (class III or more as defined by American Heart Association) Electrolytes: Potassium at least 3.4 meq/L Magnesium at least 1.4 meq/L Other: Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior high dose chemotherapy with stem cell transplant At least 3 courses of first line chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Study Objectives This pilot clinical trial studies positron emission tomography (PET)-magnetic resonance imaging (MRI) and PET-computed tomography (CT) as diagnostic imaging in patients with colon and/or rectal cancer. New diagnostic imaging procedures, such as PET-MRI, may help find and diagnose rectal cancer or recurrence of colorectal cancer Conditions: Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IIA Colon Cancer, Stage IIA Rectal Cancer, Stage IIB Colon Cancer, Stage IIB Rectal Cancer, Stage IIC Colon Cancer, Stage IIC Rectal Cancer, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer Intervention / Treatment: PROCEDURE: positron emission tomography, PROCEDURE: computed tomography, PROCEDURE: magnetic resonance imaging, RADIATION: fludeoxyglucose F 18 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: * Either having a T3 (the cancer has grown through the muscularis propria and into the outermost layers of the colon or rectum but not through them) or higher, node positivity or metastatic lesion in the context of rectal cancer or being studied for colorectal cancer follow up, independent of the renal function * PET-CT should be requested by a referring physician; in the case of having an MR requested as well, it will be reported from the MRI images generated in the PET-MRI * Stable physical medical conditions to undergo a MRI * Informed consent must be given and signed prior to study enrollment Exclusion Criteria: * Refuse to give and/or sign the informed consent * Subjects who do not meet the above mentioned inclusion criteria * Subjects who have a pacemaker * Subjects who have a metallic prostheses either in the pelvis or in the abdomen that will interfere with the MR imaging of that anatomical area * Subjects who suffer from claustrophobia * Pregnant women * Cognitive impairment that affects the subject's ability to give consent

Study Objectives This is a randomized, open-label, multicenter, prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in participants who have newly diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone marrow transplantation. Conditions: Mantle Cell Lymphoma Intervention / Treatment: DRUG: Rituximab 375 mg/m^2, DRUG: Cyclophosphamide 750 mg/m^2, DRUG: Doxorubicin 50 mg/m^2, DRUG: VELCADE 1.3 mg/m^2, DRUG: Prednisone 100 mg/m^2, DRUG: Vincristine 1.4 mg/m^2 Location: Taiwan, Malaysia, Turkey, South Africa, Portugal, Colombia, Thailand, India, Austria, Singapore, Israel, Romania, Spain, Czechia, Tunisia, Philippines, Chile, Hungary, Germany, United States, China, Canada, Russian Federation, Poland, Italy, Ukraine, Morocco, Belgium, Brazil Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Male or female patients 18 years or older (the patient must be at least the legal age limit to be able to give informed consent within the jurisdiction the study is taking place) * Diagnosis of mantle cell lymphoma MCL (Stage II, III or IV) as evidenced by lymph node histology and either expression of cyclin D1 (in association with CD20 and CD5) or evidence of t(11;14) translocation, such as by cytogenetics, fluorescent in situ hybridization (FISH) or polymerase chain reaction (PCR). Patients with a diagnosis of Stage I MCL will not be permitted to enter study. - Paraffin embedded biopsy tissue block (preferably of lymph node origin) must be sent to the central laboratory for confirmation of MCL diagnosis prior to randomization. In China, a paraffin embedded lymph node biopsy tissue block must be sent for central confirmation of sample adequacy, prior to randomization * At least 1 measurable site of disease * No prior therapies for MCL * Not eligible for bone marrow transplantation as assessed by the treating physician (e.g., age or the presence of co-morbid conditions that may have a negative impact on the tolerability to transplantation). * Eastern Cooperative Oncology Group ECOG status ≤2 * Absolute neutrophil count (ANC) ≥1500 cells/µL, * Platelets ≥100,000 cells/µL or ≥75,000 cells/µL if thrombocytopenia is considered by the investigator to be secondary to MCL (e.g., due to bone marrow infiltration or sequestration from splenomegaly). * Alanine transaminase ≤3 x upper limit of normal (ULN) * Aspartate transaminase ≤3 x ULN * Total bilirubin ≤1.5 x ULN, * Calculated creatinine clearance ≥20 mL/min. * Female patients must be post menopausal for at least 1 year (must not have had a natural menses for at least 12 months), surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) and have a negative serum βHCG or urine pregnancy test at screening. They must also be prepared to continue birth control measures for at least 6 months after terminating treatment. * Male patients must agree to use an acceptable method of contraception (for themselves or female partners as listed above) for the duration of the study. * All patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. * In order to participate in the pharmacogenomics component of this study, patients (or their legally acceptable representative) must have signed the informed consent form for pharmacogenomics research indicating willingness to participate in the pharmacogenomics component of the study. Acquisition of tumor sample collections is required for all patients (where available); all other sample collections are optional Exclusion Criteria: * Prior treatment with VELCADE * Prior antineoplastic (including unconjugated therapeutic antibodies), experimental or radiation therapy, radioimmunoconjugates or toxin immunoconjugates for the treatment of MCL. In the event that a patient has received doxorubicin for the treatment of any condition, other than MCL, the maximum dose and exposure received prior to entry into this study should not exceed 150 mg/m2. - short course (maximum of 10 days, not exceeding 100 mg/day) prednisone or equivalent steroids are allowed to treat symptoms in patients with advanced disease who enter the screening phase and are waiting to be randomized. * Major surgery (at the discretion of the treating physician and in consultation with the sponsor's medical monitor) within 2 weeks before randomization * Peripheral neuropathy or neuropathic pain of Grade 2 or worse (as per the investigators assessment) * Diagnosed or treated for a malignancy other than MCL within 1 year of randomization, or who were previously diagnosed with a malignancy other than MCL and have any radiographic or biochemical marker evidence of malignancy. Patients with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy are not excluded. * Active systemic infection requiring treatment and patients with known diagnosis of human immunodeficiency virus HIV or active hepatitis B (carriers of hepatitis B are permitted to enter study) * History of allergic reaction attributable to compounds containing boron, mannitol, or hydroxybenzoates * Known anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab including polysorbate 80 and sodium citrate dihydrate * Female or male patients of child-bearing potential who will not use adequate contraception during the course of the study. * Serious medical (e.g., pericardial disease, cardiac failure \[New York Heart Association; NYHA Class III or IV, Attachment 12 or left ventricular ejection fraction; LVEF \<50%\], active peptic ulceration, uncontrolled diabetes mellitus, or acute diffuse infiltrative pulmonary disease), or psychiatric illness likely to interfere with participation in this clinical study * Concurrent treatment with another investigational agent.

Study Objectives Fifty eligible breast cancer survivors (median, 10 yrs after surgery) with arm lymph-edema (median, 21% inter limb difference) were included and randomized into the intervention(group A, n = 25) or control ( Group B, n = 25). Intervention group received 60 minutes aquatic-based exercise in the form of warm-up for 10 mins, then strengthening exercise for 40 minutes, followed by 10 min cooling down in the form of stretching and mobility exercise, three times a week for 8 weeks, plus land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise. The control group received 60 minutes of land base exercise, three times a week, for 8 weeks. Arm volume, shoulder flexion, abduction range of motion and pain using a visual analogue scale were assessed at baseline and after 8 weeks of treatment. Conditions: Breast Cancer Intervention / Treatment: OTHER: aquatic based exercise., OTHER: land-based exercise. Location: Egypt Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Breast cancer with unilateral axillary lymph node excision. * Mild-moderate degreed lymphedema (stage I and II) . * Lymphedema with a duration of at least 1 year . Exclusion Criteria: * Recurrence of cancer. * Ongoing active oncological treatment. * Functional disorders hindering participation in exercise programs. * Open wound at any area of the body.

Study Objectives The investigators' group was the first to perform a phase II trial in patients with limited disease (stage I-III) small-cell lung carcinoma (SCLC) in which only the fluorodeoxyglucose-positron emission tomography (FDG-PET) positive lymph nodes were irradiated. In this trial, only 3% of isolated nodal failures were observed. However, all patients in that study were treated with 3D conformal radiotherapy (3DCRT). At present, IMRT techniques have become more standard in lung cancer. Because of the lower radiation dose to the lymph nodes outside of the planning target volume (PTV) with IMRT, higher incidences of isolated nodal failures may occur. In this trial, the investigators will investigate the patterns of local relapse after IMRT with concurrent chemotherapy in patients with stage I-III SCLC. Conditions: Stage I-III Small Cell Lung Cancer Intervention / Treatment: RADIATION: Radiotherapy Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Histological of cytological proven SCLC * UICC stage I-III, which are amendable for radical local treatment * Performance status 0-2 * IMRT technique Exclusion Criteria: * Not SCLC or mixed SCLC and other histologies (e.g. non-small cell carcinoma) * Stage IV * Performance status 3 or more * No IMRT technique

Study Objectives This trial studies how well black raspberry nectar works in changing the gut microbiome and in reducing inflammatory processes that may lead to lung cancer. Studying the effects of black raspberry beverage on inflammation may help doctors find strategies to reduce the risk of developing lung cancer. Conditions: Lung Carcinoma, Tobacco-Related Carcinoma Intervention / Treatment: PROCEDURE: Biospecimen Collection, DIETARY_SUPPLEMENT: Nutritional Supplementation, DRUG: Placebo Administration, OTHER: Questionnaire Administration Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: EARLY_PHASE1 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: CROSSOVER Masking: SINGLE

Inclusion Criteria: * Have a 30 pack-year smoking history * Be either a current smoker or a former smoker that quit in the last 15 years. Any individual who is currently smoking and has smoked more than 100 cigarettes in their lifetime will be identified as a current smoker * Agree to consume a standardized vitamin / mineral supplement and avoid other nutritional, dietary or alternative medications / supplements / probiotics for the duration of the study * Agree to follow a berry-free / controlled phenolic diet and to document consumption of polyphenolic foods each day of the study using a simple daily form Exclusion Criteria: * Person has an allergy to any berries, pectin, or food colorants apples,as well as kiwi fruit, strawberries, soy sauce, pine nuts, almonds, cherries, peaches, blackberries, pears * Person states that they are not a: * Current smoker: active cigarette smoker who has smoked more than 30 pack-years in the last 15 years OR * Former smoker: not a current smoker active cigarette smoker who has smoked more than 30 pack years in the last 15 years * Person is unwilling to follow a berry-free/controlled polyphenol diet while on study * Person has history of metabolic disorders (diabetes, hyper/hypo-thyroidism, etc.); digestive illness which may result in nutrient malabsorption (Crohn's disease, Celiac, renal/hepatic insufficiency, short bowel, etc.); disorders that affect connective tissues; or blood clotting disorders * Person has allergy or food intolerance to ingredients in study products (black raspberries or other berries) * Person is on a regimen of any of the following medications: * Immunosuppressants, bisphosphonates, or steroids. * Anticoagulants (warfarin, apixaban, dabigatran, and rivaroxaban) * Probiotics * Person is undergoing treatment for cancer in any form * Person is currently pregnant or nursing or plans to become pregnant during this study * Person plans to enter smoking cessation or change their smoking status during the course of the study

Study Objectives RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining combination chemotherapy with hormone therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without tamoxifen in treating women with stage I or stage II breast cancer that can be surgically removed. Conditions: Breast Cancer Intervention / Treatment: DRUG: CMF regimen, DRUG: cyclophosphamide, DRUG: fluorouracil, DRUG: methotrexate, DRUG: tamoxifen citrate, PROCEDURE: conventional surgery, RADIATION: radiation therapy Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: Masking:

DISEASE CHARACTERISTICS: Histologically confirmed breast cancer with palpable, unilateral, invasive disease Bilateral mammography required within 1 year prior to randomization TNM Stage T1-3, N0-1, M0 disease for which adjuvant chemotherapy is considered an essential part of initial therapy No prior pure in situ carcinoma in either breast No concurrent in situ carcinoma only No Paget's disease of the nipple without underlying invasion No evidence of distant disease, e.g.: No ipsilateral supraclavicular node enlargement unless proven benign Hormone receptor status: Any status PATIENT CHARACTERISTICS: Age: Not specified Sex: Women only Menopausal status: Pre- or postmenopausal Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No serious unrelated illness No prior invasive malignancy at any other site except adequately treated nonmelanomatous skin cancer No pregnant or nursing women Adequate contraception required PRIOR CONCURRENT THERAPY: No prior tamoxifen and not currently receiving tamoxifen

Study Objectives The goal of this project is to examine the physical and psychological health benefits of a novel, telephone-delivered symptom management intervention for advanced lung cancer patients and their family caregivers. Conditions: Lung Cancer Intervention / Treatment: BEHAVIORAL: Telephone counseling, BEHAVIORAL: Education Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: * Clinical diagnosis of lung cancer * Must be able to speak and read English Exclusion Criteria: * No working phone service * Does not have a family caregiver

Study Objectives The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone. Conditions: Gastric Neoplasm Intervention / Treatment: PROCEDURE: Gastrectomy with more than D2 dissection, DRUG: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy Location: Japan Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: 1. histologically proven adenocarcinoma of stomach 2. Borrmann type 4 or large (\>=8 cm) type 3 3. no evidence of distant metastasis including liver(M0) 4. no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2) 5. no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with laparoscopic confirmation 6. no involvement of the esophagus with \> 3cm 7. an age of 20-75 years 8. an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 9. no prior chemotherapy, radiotherapy for any malignancy 10. no prior surgery for gastric cancer except for endoscopic membrane resection (EMR) 11. no breeding from primary tumor or gastrointestinal stenosis 12. sufficient oral intake 13. adequate organ function 14. written informed consent Exclusion Criteria: 1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2. pregnant or breast-feeding women 3. severe mental disease 4. systemic administration of corticosteroids, flucytosine, phenytoin or warfarin 5. other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease 6. myocardial infarction within six disease-free months

Study Objectives This study will collect 5 year data about any possible health problems associated with breast implants. This data will be used to help see if the implants are both safe and effective. If they are proven safe and effective, they will continue to be available. If they are not proven safe and effective to the satisfaction of the FDA, they may not be available in the future. Conditions: Breast Reconstruction With Silicone Implants Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Females of any age for which breast reconstruction is considered appropriate. (Patients under 18 years old require parental/legal guardian consent to participate). * Have any of the following conditions or situations present: * Post mastectomy surgical removal of the breast for cancer or other diseases; * Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity.(for any reason); * Severe ptosis requiring reconstruction (i.e. mastopexy);. * Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity. This does not include normal variants of asymmetry. Examples include, but are not limited to:Pectus excavatum, Pectus carinatum; Thoracic hypoplasia (Poland's syndrome, Scoliosis; Isolated rib deformities; Tuberous breasts; Congenital absence * Revision of implant procedure due to any of the following circumstances; * Previous augmentation or reconstruction with silicone- or saline-filled implants where problems exist, such as implant. rapture or significant capsular contracture (Baker Grade III or IV) requiring revision; * Contralateral mammaplasty in unaffected breast as a result of the affected breast requiring surgery (for one of the aforementioned circumstances), when medically indicated to provide symmetry. * Adequate tissue available to cover implants. * Saline-filled implants are not an appropriate choice. * Willingness to follow all study requirements, such as agreeing to all required follow-up visits, and acceptance of the risks involved as indicated by signing of the Patient Informed Consent document. Exclusion Criteria: * Advanced fibrocystic disease considered to be premalignant-without accompanying subcutaneous mastectomy. * Existing carcinoma of the breast, without mastectomy. * Abscess or infection in the body at the time of enrollment. * Pregnant or nursing. * Have any disease, including uncontrolled diabetes; which is clinically known to impact wound healing ability. * Show tissue characteristics which are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration. * Have, or under treatment for, any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk. * Show psychological characteristics which, in the opinion of the surgeon, may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation. * Wish to have augmentation mammaplasty, but do not have at least one of the diagnoses identified in Patient Inclusion Criteria item G #2, pages 7 \& 8. * Are not willing to undergo further surgery for revision, if medically required. * Diagnosis of lupus or scleroderma. * Replacement of saline-filled implants solely for a less than desirable cosmetic outcome, such as wrinkling.

Study Objectives This study is an open, non- randomized, phase I, dose-escalating study to evaluate the safety and tolerance of Amphinex based PCI of bleomycin in patients with local recurrent or advanced/metastatic, cutaneous or sub-cutaneous malignancies. Conditions: Head and Neck Neoplasms, Skin Neoplasms Intervention / Treatment: DRUG: Amphinex (TPCS2a), DRUG: Bleomycin, OTHER: Illumination with CeramOptec laser Location: United Kingdom Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Male or female aged 18 years or above who have given written informed consent. * Skin type I- IV according to the Fitzpatrick skin classification (see appendix G). * With a diagnosis of local recurrence or advanced/metastatic, cutaneous or subcutaneous malignancy * Lesion measurement must not be done more than 2 weeks before the beginning of treatment. More than one field with lesion can be illuminated, but care must be taken to avoid overlap of the fields illuminated. * Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, anticancer hormone therapy, or other investigational therapy for at least 2 weeks prior to study entry, and have recovered from the acute effects of therapy. * Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale (see appendix D). * Clinically assessed as eligible for bleomycin chemotherapy. * Have a predicted life expectancy of at least 3 months. * Geographic proximity that allow adequate follow-up. * If female: have had childbearing potential either terminated by surgery, radiation, or menopause or attenuated by the use of an approved contraceptive method during and for 3 months after the trial. * If male: have had reproductive potential either terminated or attenuated by the use of an approved contraceptive method during and for 3 months after the trial. Exclusion Criteria: * Have received prior PCI. * Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site. * Planned surgery in first 28 days after treatment, except for planned surgical removal of the treated lesion. * Planned dentist appointments in first 28 days after treatment. * Anticancer therapy within the first 28 days after treatment. * Therapy with drugs that induce light sensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea, hypoglycemic agents, thiazide diuretics, and griseofulvin) within the first 14 days after treatment. * Co-existing ophthalmic disease likely to require slit-lamp examination within the first 28 days after treatment. * History of hypersensitivity/anaphylactic reactions. * Previous cumulative dose of Bleomycin received over 200 000 IE * Known allergy or sensitivity to photosensitisers. * Known allergy to Cremophor. * Known allergy to bleomycin. * Conditions contraindicated for bleomycin treatment (lung infection, impaired pulmonary function). * Conditions that worsen when exposed to light (including porphyria). * Conditions associated with a risk of poor protocol compliance. * Pregnancy or breastfeeding.

Study Objectives Observational study. All HIV-infected patients who have been diagnosed of hepatocellular carcinoma (HCC), following the American Association for the Study of Liver Diseases (AASLD) criteria, in the participant centers are included. Epidemiological, clinical and laboratory data are collected. The clinical and epidemiological characteristics of HCC cases will be analyzed. The efficacy and outcomes after modalities of HCC therapy will be assessed. Mortality and its predictors will be also assessed. In those cases infected by hepatitis C virus (HCV), the impact of HCV therapy on outcomes will be analysed. Conditions: Hepatocellular Carcinoma, HIV, Chronic Hepatitis C, Hepatitis B Virus, Liver Cirrhosis Intervention / Treatment: Location: Spain Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * HIV infection * Diagnosis of hepatocellular carcinoma according to American Association for the Study of Liver Diseases (AASLD) criteria Exclusion Criteria: * None

Study Objectives The present trial will be performed to determine the MTD and to evaluate the efficacy of BI 2536 in the treatment of elderly patients with relapsed or refractory AML. Different schedules will be compared to identify the better dosing schedule for the further development programme of BI 2536. Dose escalation starting with the maximum tolerated dose previously determined in patients with advanced solid cancers will be performed to determine the maximum tolerated dose for AML patients. Conditions: Leukemia, Myeloid, Acute Intervention / Treatment: DRUG: BI 2536 Location: Austria, Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE2 Primary Purpose: TREATMENT Allocation: Interventional Model: PARALLEL Masking:

Inclusion Criteria: * Male or female patients older than 60 years of age * Patient with confirmed AML (except for APL) according to the WHO definition who relapsed after or are refractory to prior chemotherapy * Leukocyte count \<= 25,000 /mcl (25 x 10e9/Liter) * Patient not eligible for intensive treatment options * Life expectancy \>= 2 months * Eastern co-operative oncology group performance score of 2 or less * Signed written informed consent consistent with international conference on harmonisation - good clinical practice (ICH-GCP) and local legislation Exclusion Criteria: * Patient with acute promyelocytic leukaemia (APL, AML of the French-American-British (FAB) classification subtype M3) * Hypersensitivity to the trial drug or the excipients * Secondary malignancy requiring therapy * Known central nervous system involvement * Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal, or AST or ALT greater than 5 times the upper limit of normal in case of known liver involvement * Bilirubin greater than 1.5 mg/dl (\> 26 mcmol/l, SI unit equivalent) * Serum creatinine greater than 2.0 mg/dl * Concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia * Psychiatric illness or social situation that would limit compliance with trial requirements * Concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug * Chemotherapy (except hydroxyurea) or immunotherapy or treatment with any other investigational drug within the past four weeks prior to treatment with the trial drug * Persistence of toxicities of prior anti-leukaemia therapies which are deemed to be clinically relevant * Patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.) * Patient unable to comply with the protocol

Study Objectives Survivors of Hodgkin Lymphoma (HL) are known to have an increased risk of developing late treatment sequelae such as cardiovascular events due to coronary artery disease. At present no active screening is performed in these patients since it is not known whether screening and subsequent treatment by means of revascularization is effective in reducing the risk of cardiovascular events in symptomatic individuals. In the trial the efficacy and therapeutic consequences of screening for coronary artery diasease by multi-slice CT (MSCT) among asymptomatic HL survivors will be evaluated. Conditions: Radiation Therapy, Coronary Artery Disease, Hodgkin Lymphoma Intervention / Treatment: RADIATION: CT coronary angiography Location: Netherlands Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SCREENING Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * history of Hodgkin Lymphoma(all stages) with at least 10 disease free survival * current age between 35-60 * mediastinal irradiation as part of HL treatment, radiotherapy data available * written informed consent Exclusion Criteria: * current treatment for cardiovascualr disease, excelt hypertension hypercholesterolemia or cardiac murmurs * known or sypmtomatic heart failure * impaired kidney function (Cockcroft \< 55 ml/min) * known contrast allergy * invasive angiography in past 2 years * presence of life threatening disorder

Study Objectives The investigators propose to study the safety and efficacy of the combination of Carboplatin plus Gemcitabine in a Phase I/II trial of elderly subjects with non-small cell lung cancer. Conditions: NSCLC Intervention / Treatment: DRUG: Carboplatin, DRUG: Gemcitabine Location: Greece Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Age ≥70 years old * Cytologically or histologically documented NSCLC * Measurable disease according to Response Evaluation Criteria in Solid Tumors (at least one measurable lesion) * World Health Organisation (WHO) performance status 0-2 * Non-frail patients according to Comprehensive Geriatric Assessment * Previously treated NSCLC (or patients for whom the combination is considered adequate treatment) (for phase I part) * No prior chemotherapy (for phase II part) * Life expectancy of at least 12 weeks * Serum bilirubin less than 1.5 times the upper normal limit * Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit in the absence of demonstrable liver metastases, or less than 5 times the upper normal limit in the presence of liver metastases * Serum creatinine less than 1.5 times the upper normal limit and Creatinine Clearance \>60 ml/min * Neutrophil count more than 1.5x 109 /L * Platelet count more than 100x 109 /L * Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations. Exclusion Criteria: * Hemoptysis * Central nervous system metastases * Clinically significant cardiovascular disease * Medically uncontrolled hypertension * Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ) * Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)

Study Objectives Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release. Conditions: Breast Cancer Intervention / Treatment: DEVICE: Genesis and Gemini, DEVICE: Investigational 3D Mammography system Location: Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Female, any ethnic origin * No contraindication for diagnostic mammography Exclusion Criteria: * Any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants. * Under 30 years of age at the time of consent * Unable to understand and execute written informed consent

Study Objectives Epidemiologic studies suggest that low dietary intakes and low plasma concentrations of antioxidant vitamins and minerals are associated with increased risks of cancer, especially for epidermoid tumors. Patients with stage I or II head and neck cancer have a good prognosis, with a 5-year relative survival of 60% to 90%, depending of the tumor site. However, the benefit of treatment is often compromised by the occurrence of second primary cancers, which develop in 20% of patients during the first 5 years after diagnosis. We conducted a randomized chemoprevention trial among patients with head and neck cancer treated by radiation therapy to determine whether supplementation combining two antioxidants, alpha-tocopherol and beta-carotene, could reduce the incidence of second primary cancers in this patient population (primary objective of the trial). This study was conducted with funds from the NCIC (#008176,004738,013211) and was completed. In this cohort of head and neck cancer patients, we evaluated whether nine potential prognostic serum markers measured at the time of diagnosis were related to recurrence, occurence of second primary cancers and survival. This study was conducted with funds from the NCIC (#018100) and was completed. Presently, we evaluate genetic polymorphisms(GWAS) associated with prognosis (NCIC grant #019502). We also assess the relationship between vitamin D (dietary intake, serum level, and genetic polymorphisms of key vitamin D-related genes) and head and neck long-term outcomes (NCI grant #1R03CA141615-01). Conditions: Neoplasms Intervention / Treatment: DIETARY_SUPPLEMENT: Alpha-Tocopherol and Beta-Carotene, DIETARY_SUPPLEMENT: Placebo Location: Canada Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: QUADRUPLE

Inclusion Criteria: * Histologically documented stage I or II head and neck cancer Exclusion Criteria: * Karnofsky performance score of less than 60 * Multiple primary head and neck cancer * History of cancer * Severe cardiovascular disease * Inadequate renal, hepatic or hematologic function * Anticoagulant therapy * Pregnancy * Average daily supplement intake of beta-carotene or vitamin E in the preceding year greater than 6.0 mg and 50 IU, respectively.

Study Objectives In the study proposed, up to 1,500 men age 60 and over with strong smoking histories will test their urine for the presence of blood daily for two 10-day testing periods with the Ames Hemastix. Individuals with even a solitary positive test will undergo a thorough urologic evaluation to determine the cause of hematuria and follow-up will continue for 2 years after completion of the study. Conditions: Bladder Cancer Intervention / Treatment: OTHER: Specimen and questionnaires only Location: Canada, United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Men age 60 and over, - who are current cigarette smokers OR - who have a history of at least 20 pack years smoking OR - who have over a 30 pack/year history who have stopped smoking within 10 years of the registration date OR - who have a 40 pack year history of smoking regardless of the quit date, will be eligible for participation. * Patients with prostate or renal cancer must have been treated more than 5 years previously and be considered disease-free at the time of entry. In the case of prostate cancer, patients may have only received prostatectomy as their treatment and must have undetectable PSA's at study entry. * In the case of calculus disease, patients must be believed to be stone free at time of study entry and could not have had a stone attack within the previous 2 years. * Patients receiving anticoagulation therapy, such as Warfarin, Plavix, Lovenox, aspirin, etc. will be able to take part in the study and, will be thoroughly worked-up if the only explainable cause of hematuria is receiving anticoagulation medication. Exclusion Criteria: * history of urothelial cancer * any malignancy other than non-melanoma skin cancers treated within the past 5 years * benign tumors of the urinary tract that are still existent * known urinary calculi * medical or oncological conditions known to produce hematuria (e.g. glomerulonephritis, treatments with cyclophosphamide, methotrexate and pelvic radiation therapy) * visual, psychological, neurological, musculoskeletal, etc. impairments that would make home testing impractical

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

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

Study Objectives Several multicenter studies have shown the equivalence of hypofractionated radiotherapy and normofractionated radiotherapy after breast-conserving surgery. However, the treatment in these studies was carried out with conventional techniques and not with the modern IMRT. Also the evaluation of quality of life and cosmetic outcome were not standardized. This study is a two-arm prospective study comparing normofractionated and hypofractionated radiotherapy in patients with breast cancer using tangential IMRT techniques. The primary endpoints are acute and chronic cosmetic breast changes. The secondary endpoint is the patients' quality of life. Patients to be included are breast cancer 60 years old patients or older with tumour stages pTis-pT3, pN0-pN1a, M0 after breast-conserving surgery. Patients with right sided breast cancer are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15 fractions) and the left sided breast cancer a normofractionated irradiation (50/2Gy in 25 fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy). In both groups, a tangential intensity-modulated radiation technique aiming to achieve optimal dose homogeneity is applied. Since higher single radiation dose to the heart can lead to higher morbidity and/or mortality, patient stratification according to the diseased side was adopted where the left-sided breast cancer patients would receive normofractionated 2Gy single dose. Therefore there is no randomization. For classification and grading of adverse cosmetic events, the "Common Toxicity Criteria (CTC-AE V3.0) and the recognized LENT-SOMA scores are to be regularly documented. Quality of life is to be documented with two standardized, validated questionnaires "QLQ C30 and BR23" of the EORTC (European Organization for Research and Treatment of Cancer). The questionnaires are to be filled by the patients themselves at different time points during the study period. A sum of grade III fibrosis, grade III telangiectasia and grade II hyperpigmentation of around 20% is expected after 2 years. Therefore, calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 15% within 2 years results in the need for recruiting 226 patients (113 in each arm) (non-inferiority of hypofractionated therapy). Conditions: Tumors, Breast Cancer Intervention / Treatment: RADIATION: intensity modulated radiotherapy (IMRT) for breast cancer Location: Germany Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE3 Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: PARALLEL Masking: NONE

Inclusion Criteria: * Histologically confirmed invasive or in situ breast cancer, tumor stage pTis-pT3, pN0-1a, M0 * Age ≥ 60 years * signed informed consent from the patient Exclusion Criteria: * Stage pN1b-PN3, pT4 and / or M1 * incomplete surgical resection * after mastectomy of the ipsilateral or contralateral breast * breast reconstruction with implant or expander insert * bilateral breast cancer * Lack of compliance or consent * Indications for irradiation of the axillary, supraclavicular or parasternal lymph nodes

Study Objectives The purpose of this study is to: (1) develop a communication-based intervention to improve advanced cancer patients' and caregivers' prognostic understanding using communication strategies (e.g., acknowledgment, validation of fears) and distress management techniques (e.g., deep breathing, muscle relaxation); (2) evaluate the feasibility and acceptability of the intervention among advanced cancer patients and their caregivers; and (3) test the preliminary efficacy of the intervention on patients' and caregivers' prognostic understanding (primary outcome); completion of DNR order, living will, and health care proxy; psychological distress; communication quality; caregiver burden; and healthcare utilization (secondary outcomes). Conditions: Advanced Cancer Intervention / Treatment: BEHAVIORAL: Talking about Cancer (TAC) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: SUPPORTIVE_CARE Allocation: NON_RANDOMIZED Interventional Model: SINGLE_GROUP Masking: NONE

Patient Inclusion Criteria: * Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer (e.g., pancreaticobiliary, esophagogastric, hepatocellular carcinoma, lung, or gynecological cancer) and/or disease progression following at least first line chemotherapy. * Ability to provide informed consent * Identification of an informal caregiver * Oncologist reported discussion of prognosis with the patient and/or caregiver. Patient Exclusion Criteria: * Not fluent in English * Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of \< 6) * Too ill or weak to complete the interviews (as judged by the interviewer) * Currently receiving palliative care/hospice at the time of enrollment * Children and young adults under age 18 * Deemed inappropriate for the study by their treating oncologist. * In addition, patient-caregiver dyads in which both members have an accurate understanding of prognosis (terminal status and life-expectancy) will be excluded due to the lack of need for an intervention. Caregiver inclusion criteria: * The person (family member or friend) whom the patient indicates provides their informal (unpaid) care * English speaking * Able to provide informed consent

Study Objectives Qualitative data were collected from 5 General Practionners (GPs) focus groups, 24 patient interviews and 35 recorded consultations from 9 GPs to explore colorectal cancer (CRC) screening in France The qualitative data indicated that improvement was needed in patient-centered communication. Educational material was developed based on these triangulated data with two different scenarios to improve communication with patients: one for a compliant patient, another for a non compliant patient The hypothesis is that a brief intervention on GPs can improve the patients' participation rate to colorectal screening Method : cluster randomized control trial (cluster unit : GPs practices) With a brief intervention on a randomized population of GPs in the district of Val d'Oise Inclusion criteria: GPs with a practice in the district of Val d'Oise and active in the colorectal mass screening Conditions: Colorectal Cancer Intervention / Treatment: BEHAVIORAL: GPs communication skills and CRC screening Location: France Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: PREVENTION Allocation: RANDOMIZED Interventional Model: PARALLEL Masking: SINGLE

Inclusion Criteria: Inclusion of GPs practices: All GPs practices of the Val d'Oise department in France were eligible to participate GPs using complementary therapies occasionally were allowed to participate Exclusion Criteria: Exclusion of GPs practices : practices were excluded when doctors used exclusively complementary therapies (acupuncture therapy, homeopathy....) -

Study Objectives The primary purpose of this trial is to evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects. Conditions: Lesion Skin, Seborrheic Keratosis Intervention / Treatment: DEVICE: Nano-Pulse Stimulation (NPS) Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: NA Primary Purpose: TREATMENT Allocation: NON_RANDOMIZED Interventional Model: SEQUENTIAL Masking: SINGLE

Inclusion Criteria: * Willing to sign the informed consent * Has a clinical diagnosis of stable, clinically typical seborrheic keratosis * Medically determined candidate for at least 4 off-face SK lesions * Must have at least four treatable SK lesions and be willing to have NPS treatment on any three of the four treatable SK lesions. Treatable SK lesions must: be at least 1 mm in height, and no greater than 3 mm in height and not have a dimension perpendicular to the longest dimension of greater than 7.5mm or longer in any dimension than 20mm * Willing to have three of the designated SK lesions treated in a single treatment session * Willing to return to the PI's office for five additional study visits at specified intervals over 106-days * Agrees to high resolution photos of both the treated SK lesions and the untreated SK lesion * No subject identity will be possible via the "lesion-only" photograph * No evidence of active infection in the designated tissue prior to treatment * Is not allergic to Lidocaine or Lidocaine-like products * Not pregnant or lactating Exclusion Criteria: * Has an implantable electronic device (e.g., automatic defibrillator) * Active infection or history of infection within 90 previous days in designated test area * Not willing or able to sign the Informed Consent * Non-English speaking or reading * Is known to be immune-compromised * Known to be a keloid producer * On blood thinning medications * Diseases, conditions, or situations wherein the PI judges that the patient is not appropriate for participation in the study

Study Objectives Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may make tumor cells more sensitive to radiation therapy. Combining tipifarnib with radiation therapy may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of tipifarnib to see how well it works when given together with radiation therapy in treating young patients with newly diagnosed brain stem glioma. (Phase I closed to accrual as of 1/19/06) Conditions: Untreated Childhood Brain Stem Glioma Intervention / Treatment: RADIATION: radiation therapy, DRUG: tipifarnib Location: United States Study Design and Phases Study Type: INTERVENTIONAL Phase: PHASE1, PHASE2 Primary Purpose: TREATMENT Allocation: NA Interventional Model: SINGLE_GROUP Masking: NONE

Inclusion Criteria: * Newly diagnosed non-disseminated intrinsic diffuse brainstem glioma * Karnofsky performance scale (KPS) (for \> 16 yrs of age) or Lansky performance score (LPS) (for =\< 16 years of age) =\> 50 assessed within two weeks prior to registration * Prior/concurrent therapy: * Chemo: No prior therapy allowed * Radiation therapy (XRT): No prior therapy allowed * Bone Marrow Transplant: None prior * Anti-convulsants: Patients receiving EIACDs will not be eligible; however, patients may switch from EIACDs to non-EIACDs and must then be on non-EIACDs for a minimum of 7 days prior to registration * Growth factors: Off all colony forming growth factor(s) \> 2 weeks prior to registration (G-CSF, GM-CSF, erythropoietin) * Absolute neutrophil count \>= 1,000/mm\^3 * Platelets \>= 100,000/mm\^3 (transfusion independent) * Hemoglobin \>= 8 gm/dL (transfusion independent) * Serum creatinine that is less than the upper limit of institutional normal for age or GFR \> 70 ml/min/1.73m2 * Bilirubin =\< 1.5 time upper limit of normal for age * SGPT (ALT) and SGOT (AST) \< 2.5 times institutional upper limit of normal * Female patients of childbearing potential must have negative serum or urine pregnancy test; patient must not be pregnant or breast-feeding * Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study * Signed informed consent according to institutional guidelines must be obtained Exclusion Criteria: * Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy; patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism * Patients with disseminated intrinsic diffuse brainstem glioma * Patients taking enzyme-inducing anticonvulsant drugs * Patients with known allergy to topical or systemic imidazoles (e.g., clotrimazole, ketoconazole, miconazole, econazole) * Patients receiving any other anticancer or experimental drug therapy * Patients with uncontrolled infection

Study Objectives This study was designed in two phases: Phase I is designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level of comfort with the procedure. The surface of the liver will be manually swabbed with the study tracked laparoscopic probe with landmarks noted during data collection. After registration of the liver is obtained, the registration points obtained during this procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and evaluating the location of the tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The surgeon will accept or reject the registration accuracy. The hypothesis is that the surgeon will be able to successfully acquire liver surface registrations with a small learning curve for technique and will be able to proceed to Phase II of the study. Phase II contains the registration process included above but adds the additional process of tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked and displayed on the Pathfinder three dimensional (3D) image. The surgeon will use ultrasound (US) guidance to locate tumor location during the laparoscopic procedure. The images collected during this process will be recorded by Pathfinder. Conditions: Liver Cancer Intervention / Treatment: Location: United States Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Scheduled for laparoscopic liver ablation procedure * Had a preoperative CT image that includes the liver Exclusion Criteria: * Severe cirrhosis of the liver * Kidney failure or dialysis * Unable to consent

Study Objectives The aim of this non-interventional study is to assess oral vinorelbine dose schedules (initial dose, dose increase/maintenance/reduction) applied during the initial 8 weeks of treatment under routine conditions in Germany together with the underlying reasons for the respective chosen schedules. Conditions: Non-Small-Cell Lung Cancer, Breast Cancer Intervention / Treatment: DRUG: Vinorelbine oral Location: Austria, Germany Study Design and Phases Study Type: OBSERVATIONAL Phase: Primary Purpose: Allocation: Interventional Model: Masking:

Inclusion Criteria: * Written informed consent of the patient with regard to the pseudonymized documentation and processing of his/her disease data * Legally capable male or female NSCLC patient or legally capable female MBC patient; in both situations: ≥ 18 years of age (no upper limit) * Presence of any of the following two tumor entities: * Advanced NSCLC (stage III or IV) * Anthracycline- and taxane-resistant MBC (stage IV) in women * Planned systemic chemotherapy and planned regimen with oral vinorelbine in any palliative setting (decision on treatment must have been made before inclusion in this study); included treatments: * Monotherapy or any combination therapy with oral vinorelbine * Inclusion of patients with hybrid-treatment involving i.v. and oral vinorelbine in one treatment cycle is allowed Exclusion Criteria: * Presence of any contraindication with regard to oral vinorelbine treatment (and with regard to i.v. vinorelbine in case of hybrid-treatment) according to the respective Summary of Product Characteristics (SmPC) * Oral vinorelbine based palliative treatment already ongoing or planned oral vinorelbine starting dose of \>60 mg/m2 * Presence of a Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 2 * Simultaneous participation in an interventional clinical trial