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    Participants who either do not have cancer but are at high risk for developing the disease or have had cancer and are at high risk for developing a new cancer.
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    These trials look at ways to improve the quality of life of cancer patients, especially those who have side effects from cancer and its treatment. They find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression and other health problems.
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    Ph I Dose Escalation & Cohort Expansion Study of TSR-042 in Pts w/ Advanced Solid Tumors

    Protocol: OSU-16293

    Principal Investigator: David M O'Malley, MD

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    Ph 1, BXQ-350 as a Single Agent by IV w/ Advanced Solid Tumors and Recurrent High-Grade Gliomas

    Protocol: OSU-16182

    Principal Investigator: Vinay K Puduvalli, MD

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    3-Tesla MRI in Finding Tumors in Patients With Known or Suspected Prostate Cancer

    Protocol: OSU-07042

    Eligibility:

    Inclusion Criteria:

    Patients with known or suspected prostate disease based on clinical data will be included in the study; patients with intermediate to high grade prostate cancer (Gleason’s score >= 7 and prostate-specific antigen [PSA] of > 10ng/dl) will be referred from the outpatient clinics after evaluation by the treating physicians

    Written informed consent will be signed by the patients before the MRI based on the guidelines approved by the Ohio State University Institutional Review board

    Patients must have an estimated glomerular filtration rate of >= 30 mL/min/1.73m^2 within six weeks of the MRI to be included in the study

    Exclusion Criteria:

    Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.)

    Subjects with any type of ferromagnetic bioimplant that could potentially be displaced or damaged

    Subjects that have vascular or aneurysm clips, or metallic staples from a surgical procedure

    Subjects with permanent tattoo eye liner (may contain metallic coloring)

    Subjects that may have shrapnel imbedded in their bodies, such as from war wounds, metal workers and machinists (metallic fragments in or near eyes), severe auto accident victims

    Subjects that exhibit noticeable anxiety and/or claustrophobia

    Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher

    Subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function)

    Subjects with an estimated glomerular filtration rate of < 30 mL/min/1.73m^2 within six weeks of the MRI

    Acute or chronic severe renal insufficiency (estimated glomerular filtration rate < 30 mL/min/1.73m^2)

    Acute renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period

    Principal Investigator: Michael V Knopp, MD, PhD

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    A Study of BMS-986156 Given Alone and in Combination With Nivolumab in Subjects With Advanced Solid Tumors

    Protocol: OSU-16195

    Eligibility:

    Inclusion Criteria:

    For Dose Escalation:

    Subjects with any previously treated advanced (metastatic or refractory) solid

    tumor

    For Cohort Expansion:

    Subjects must have a previously treated advanced solid tumor to be eligible

    Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy

    Women of child-bearing potential and men must use an acceptable method of

    contraception during treatment and for 23 weeks after treatment for women and 31

    weeks for men

    Exclusion Criteria:

    Known central nervous system metastases or central nervous system as the only source

    of disease

    Other concomitant malignancies (with some exceptions per protocol)

    Active, known or suspected autoimmune disease

    Uncontrolled or significant cardiovascular disease

    History of active or chronic hepatitis (e.g. Hep B or C)

    Impaired liver or bone marrow function

    Major surgery less than 1 month before start of the study

    Principal Investigator: David M O'Malley, MD

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    Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients with Prostate Cancer

    Protocol: RTOG-0924

    Eligibility:

    Inclusion Criteria:

    Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate- to high-risk for recurrence as determined by one of the following combinations:

    Gleason score 7-10 + T1c-T2b (palpation) + prostate-specific antigen (PSA) < 50 ng/mL (includes intermediate- and high-risk patients)

    Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/mL OR Gleason score 6 + >= 50% (positive) biopsies + PSA < 50 ng/ml

    Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/mL

    Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure

    History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration

    Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal computed tomography [CT] or magnetic resonance [MR]), (but not by nodal sampling, or dissection) within 90 days prior to registration

    Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1.5 cm

    No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (sodium fluoride [NaF] positron emission tomography [PET]/CT is an acceptable substitute)

    Equivocal bone scan findings are allowed if plain films (or CT or magnetic resonance imaging [MRI]) are negative for metastasis

    Baseline serum PSA value performed with a Food and Drug Administration (FDA)-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration

    Study entry PSA should not be obtained during the following time frames:

    10-day period following prostate biopsy

    Following initiation of hormonal therapy

    Within 30 days after discontinuation of finasteride

    Within 90 days after discontinuation of dutasteride

    Zubrod performance status 0-1 (unless otherwise specified)

    Absolute neutrophil count (ANC) >= 1,500/mm³

    Platelets >= 100,000/mm³

    Hemoglobin (Hgb) >= 8.0 g/dL (Note: the use of transfusion or other intervention to achieve Hgb >= 8.0 g/dL is acceptable)

    Patient must be able to provide study specific informed consent prior to study entry

    Exclusion Criteria:

    Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years (1095 days) not in the pelvis (for example, carcinoma in situ of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed); prior hematological (e.g., leukemia, lymphoma, myeloma) malignancy not allowed

    Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer

    Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

    Previous hormonal therapy, such as LHRH agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate), estrogens (e.g., diethylstilbestrol [DES]), or surgical castration (orchiectomy)

    Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is =< 45 days prior to the date of registration

    Use of finasteride within 30 days prior to registration

    Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration

    Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable

    Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields

    Severe, active co-morbidity, defined as follows:

    Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

    Transmural myocardial infarction within the last 6 months

    Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

    Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects or severe liver dysfunction

    Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients

    Patients who are sexually active and not willing/able to use medically acceptable forms of contraception

    Prior allergic reaction to the hormones involved in this protocol

    Patients status post a negative lymph node dissection are not eligible

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    Quality of Life and Supportive Care Preferences following Radiation Therapy in Prostate Cancer Survivors

    Protocol: OSU-15049

    Eligibility:

    Inclusion Criteria:

    English speaking

    Diagnosis of prostate cancer

    Treatment with primary radiation (brachytherapy or external beam therapy), radiation + androgen deprivation therapy (ADT) or salvage prostatectomy

    Body mass index (BMI) (26 - 40 kg/m^2)

    Treating oncologist consent

    Ambulatory or able to engage in walking for at least 45 minutes per intervention visit

    Sedentary lifestyle, as engaging in less than 100 minutes structured aerobic walking, cycling or swimming per week

    Exclusion Criteria:

    Poor diagnosis or other cancer

    Severe heart or systemic disease: evidence of documented myocardial infarction, chronic unstable angina, symptomatic congestive heart failure, uncontrolled hypertension

    Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician

    Non-ambulatory

    Concurrent diagnosis of organic brain syndrome, dementia, mental retardation, or significant sensory deficit

    Major mental illness (e.g., schizophrenia, major depressive disorder)

    Unwilling to give consent

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  • open for enrollment

    Cardiac MRI in Measuring the Impact of Anti-androgen Treatment on Cardiac Function in Patients with Prostate Cancer

    Protocol: OSU-14186

    Eligibility:

    Inclusion Criteria:

    Have biopsy proven carcinoma of the prostate

    Be planning to begin a course of at least 4 months of ADT; the ADT is defined as: (a) surgical castration; (b) gonadotropin-releasing hormone (GNRH) antagonist alone; (c) GNRH antagonist with oral androgen receptor blockade, and (d) GNRH antagonist, oral androgen receptor blockade, and 5-alpha reductase inhibitors; we will not include men with only oral anti-androgen therapy such as 5-alpha reductase inhibitors alone or oral anti-androgens alone

    Have an ECOG (Eastern Cooperative Oncology Group) performance status of 0-1

    Have plasma total cholesterol < 200 mg/dL

    Have plasma triglycerides < 200 mg/dL

    Have BUN/Cr (Blood urea nitrogen and serum creatinine) without clinically significant abnormalities after review by the study physicians

    Liver enzymes without clinically significant abnormalities after review by the study physicians

    CBC (complete blood count) without clinically significant abnormalities after review by the study physicians

    PT/PTT/INR (prothrombin time/partial thromboplastin time) without clinically significant abnormalities after review by the study physicians

    Voluntarily agree to participate and sign an informed consent document

    Exclusion Criteria:

    Have an active malignancy other than prostate cancer that requires therapy

    Not be undergoing evaluation and workup for active cardiovascular disease; men with treated and stable cardiovascular disease may participate

    Have plasma total cholesterol > 200 mg/dL or plasma triglycerides > 200 mg/dL

    Have a calculated glomerular filtration rate (GFR) =< 30 mL/min/1.73 m^2

    Are not free of unstable angina, arrhythmia, or severe systemic disease that would make moderate intensity exercise participation unsafe

    Have any contra-indications to magnetic resonance (MR) examination such as allergy to MRI contrast media (gadolinium-DTPA [gadopentetate dimeglumine]), metallic foreign objects within the body, orbital metal, cerebral aneurysm clip, pacemaker, defibrillator, neurostimulator, any other medical metallic implant, claustrophobia, inability to lie flat for 30 minutes, and weight exceeding 300 pounds; if an MR contraindication is discovered during scanning that was overlooked during the screening process, the procedure will be stopped immediately and the subject will be removed from the scanner

    Are receiving any form of renal replacement therapy or have a calculated glomerular filtration rate (GFR) < 30 mL/min/1.75 m²; results of serum creatinine testing will be reviewed for calculation of glomerular filtration rate (GFR); patients without a serum creatinine level drawn within the prior 3 months will have this drawn upon enrollment

    Have uncontrolled hypertension and resting blood pressure exceeding 140/80 mmHg

    In addition, subjects with any contraindications to exercise testing according to American Heart Association guidelines will not be enrolled; nonetheless, the cardiovascular magnetic resonance (CMR) cardiologist supervising the research portion of the exam will also evaluate each subject for evidence of any contra-indications; the absolute contra-indications include acute myocardial infarction, high-risk unstable angina, uncontrolled cardiac arrhythmias, active endocarditis, symptomatic severe aortic stenosis, decompensated symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, acute non-cardiac disorder that may be aggravated by exercise, acute myocarditis or pericarditis, physical disability that would preclude safe and adequate test performance, and inability to provide consent; the relative contra-indications include left main coronary stenosis, moderate stenotic valvular heart disease, electrolyte abnormalities, tachyarrhythmias or bradyarrhythmias, atrial fibrillation with uncontrolled ventricular rate, hypertrophic cardiomyopathy, and high-degree atrioventricular node block; subjects with uncontrolled hypertension and resting blood pressure exceeding 140/80 mmHg will be excluded

    Principal Investigator: Steven K Clinton, MD, PhD

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    Stereotactic Body Radiation Therapy in Treating Patients with Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer

    Protocol: NRG-BR001

    Eligibility:

    Inclusion Criteria:

    Metastatic breast cancer (MBC) OR metastatic non-small cell lung cancer (NSCLC) OR metastatic adenocarcinoma of the prostate; the sites of allowed metastases are: peripheral lung, central lung, mediastinal/cervical lymph node, liver, spinal/paraspinal, osseous, and abdominal-pelvic

    NOTE: after the required number of evaluable patients have been accrued for a given dose level, the accrual for that metastatic location will be temporarily suspended while the safety of that dose level is assessed; a patient can only be entered onto the trial if all of their metastatic locations are open to accrual (e.g. if central lung is temporarily suspended for safety assessment and the patient has a central lung metastases, regardless of other metastases, they cannot enroll until the safety of dose to central lung is determined)

    Primary tumor site without progression at registration

    All metastases not resected must be amenable to SBRT

    The patient must meet ONE of the three following criteria:

    3-4 radiographically distinct metastases of any distribution in the allowed anatomical sites OR

    2 radiographically distinct metastases that must be anatomically close (i.e., with less than or equal to 5 cm of normal tissue between them) OR

    3 or 4 distinct metastasis, 2 or 3 to be treated with SBRT and the other (s) having been surgically removed

    Evaluation by a radiation oncologist within 45 days prior to study registration

    Evaluation by a medical oncologist within 45 days prior to study registration

    The following imaging workup to document metastases within 45 days prior to study registration:

    Computed tomography (CT) scans of the chest, abdomen and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT

    History/physical examination within 45 days prior to study registration

    Zubrod performance status =< 2 within 45 days prior to study registration

    Age >= 18 years

    Absolute neutrophil count (ANC) >= 500 cells/mm^3

    Platelets >= 50,000 /mm^3

    Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

    If liver metastases present, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be < 3 x upper limit of normal (ULN)

    Patient must provide study specific informed consent prior to study entry

    For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration

    Exclusion Criteria:

    Progression of primary tumor site (breast, prostate, or lung) at time of registration

    Metastases with indistinct borders making targeting not feasible

    Known brain metastases

    Prior palliative radiotherapy to metastases

    Metastases located within 3 cm of the previously irradiated structures:

    Spinal cord previously irradiated to > 40 Gy (delivered in =< 3 Gy/fraction)

    Brachial plexus previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)

    Small intestine, large intestine, or stomach previously irradiated to > 45 Gy (delivered in =< 3 Gy/fraction)

    Brain stem previously irradiated to > 50 Gy (delivered in =< 3 Gy/fraction)

    Whole lung previously irradiated with prior volume 20 Gy (V20Gy) > 30% (delivered in =< 3 Gy/fraction)

    Primary tumor irradiated with SBRT

    Metastasis irradiated with SBRT

    Severe, active co-morbidity, defined as follows:

    Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration

    Transmural myocardial infarction within the last 6 months prior to registration

    Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

    Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration

    Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease

    Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD) 4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol

    End-stage renal disease (i.e., on dialysis or dialysis has been recommended)

    Pregnancy or women of childbearing potential not willing/able to use medically acceptable forms of contraception during protocol treatment or for at least 6 months following treatment

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