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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.
  • open for enrollment

    Ph1/2 Study of MEDI4736 in Combination with Olaparib in Pt with Advanced Solid Tumors

    Protocol: OSU-18159

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    Preop Exten Chemo vs. Chemo + Hypofrac Rad Thrpy for Resec Adenocarcinoma of Head of the Pancreas

    Protocol: ALLIANCE-A021501

    Principal Investigator: Terence M Williams, MD, PhD

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  • open for enrollment

    Whole-Brain Radiation Therapy with or without Hippocampal Avoidance in Treating Patients with Limited Stage or Extensive Stage Small Cell Lung Cancer

    Protocol: NRG-CC003

    Eligibility:

    Inclusion Criteria:

    PRIOR TO STEP 1 REGISTRATION

    Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration

    Patients must be registered on study no earlier than 7 days and no later than 56 days prior to Step 1 registration after completing chemotherapy (+/- thoracic radiotherapy)

    Patients must have a three-dimensional (3D), T1-weighted, spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan without and with gadolinium contrast-enhanced T1-weighted axial, coronal, and sagittal sequence acquisitions and standard T2-weighted axial and coronal fluid attenuation inversion recovery (FLAIR) sequence acquisitions within 28 days of Step 1 registration; to yield acceptable image quality, the pre-contrast-enhanced should have a resolution of 1 x 1 x 1.2 mm and should follow the protocols established by the Alzheimer’s Disease Neuroimaging Initiative (ADNI); performance of this sequence at a 3 Tesla field strength is recommended; sites may contact the Imaging Co-Chair, Dr. Tammie Benzinger, for further information or assistance if needed; to yield acceptable image quality, the gadolinium contrast-enhanced T1-weighted scan should use the smallest possible axial slice thickness not exceeding 1.5 mm; the associated coronal and sagittal sequences can be up to 2.5 mm in slice thickness; this imaging is considered standard of care

    Note: the MRI study is mandatory irrespective of randomization to the experimental or control arm of this study

    Prior to chemotherapy +/- or thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation involving the following:

    History/physical examination;

    Computed tomography (CT) of the chest and abdomen with contrast (does not have to be done if the patient has had a positron emission tomography (PET)/CT scan prior to initiating chemotherapy or thoracic radiotherapy)

    MRI of the brain prior to initiating chemotherapy or thoracic radiotherapy

    For patients without evidence of extensive-stage SCLC on chest and abdomen CT and brain MRI, a PET/CT or bone scan is required to confirm limited-stage SCLC

    After chemotherapy, patients must be restaged within 56 days prior Step 1 registration using the same diagnostic work-up as required pre-chemotherapy; repeat PET/CT or bone scan is not required; patients must have:

    History/physical examination

    No central nervous system (CNS) metastases (repeat MRI required)

    Radiographic partial or complete response to chemotherapy in at least one disease site using Response Evaluation Criteria in Solid Tumors (RECIST) criteria

    No progression in any site

    Zubrod performance status 0-2 within 30 days prior to Step 1 registration

    Women of childbearing potential must have a negative qualitative serum pregnancy test =< 14 days prior to Step 1 registration

    Patients who are primary English or French speakers are eligible

    Patients must sign a study-specific informed consent prior to study entry

    PRIOR TO STEP 2 REGISTRATION

    The following baseline neurocognitive assessments must be completed and uploaded within 10 calendar days after Step 1 registration: HVLT-R, TMT, and COWA; the neurocognitive assessments will be uploaded into the National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group (NRG) Oncology RAVE system for evaluation by Dr. Wefel; once the upload is complete, a notification will be sent to the site to proceed to Step 2; note: completed baseline neurocognitive assessments can be uploaded at the time of Step 1 registration

    Patients must have a baseline raw score greater than 2 on the HVLT-R delayed recall be determined by the Neurocognitive Co-Chair, Dr. Wefel

    Exclusion Criteria:

    Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields

    Radiographic evidence of CNS metastases

    Radiographic evidence of hydrocephalus

    Planned concurrent chemotherapy or anti-tumor agent during PCI

    Concomitant invasive malignancy or invasive malignancy within the past five years other than non-melanomatous skin cancer; history of in situ carcinoma (e.g. ductal carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is permitted

    Contraindication to MR imaging, such as implanted metal devices or foreign bodies or severe claustrophobia

    Severe, active comorbidity, 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

    Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

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

    Uncontrolled, clinically significant cardiac arrhythmias

    Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter

    • Note: 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 Step 1 registration
    • Note: HIV testing is not required for eligibility for this protocol

    Pregnant or lactating women or women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception

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  • open for enrollment

    HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide

    Protocol: OSU-16165

    Eligibility:

    Inclusion Criteria:

    Inclusion Criteria:

    1. Age ≥ 15 years and < 71 years at the time of signing the informed consent form

    2. Partially HLA-mismatched unrelated donor: HLA typing will be performed at high

    resolution (allele level) for the HLA-A, -B, -C, and -DRB1 loci; a minimum match of

    4/8 at HLA-A, -B, -C, and -DRB1 is required

    3. Product planned for infusion is bone marrow

    4. Disease and disease status:

    1. Acute Leukemias or T lymphoblastic lymphoma in 1st or subsequent complete

    remission (CR): Acute lymphoblastic leukemia (ALL)/T lymphoblastic lymphoma;

    acute myelogenous leukemia (AML); acute biphenotypic leukemia (ABL); acute

    undifferentiated leukemia (AUL)

    2. Myelodysplastic Syndrome (MDS), fulfilling the following criteria: Subjects with

    de novo MDS who have or have previously had Intermediate-2 or High risk disease

    as determined by the International Prognostic Scoring System (IPSS). Current

    Intermediate-2 or High risk disease is not a requirement; Subjects must have <

    20% bone marrow blasts, assessed within 60 days of informed consent; Subjects

    may have received prior therapy for the treatment of MDS prior to enrollment

    3. Chronic Lymphocytic Leukemia (CLL) in CR if RIC is to be used; in CR or partial

    response (PR) if FIC is to be used

    4. Chemotherapy-sensitive lymphoma in status other than 1st CR

    5. Performance status: Karnofsky or Lansky score ≥ 60% (Appendix A)

    6. Adequate organ function defined as:

    1. Cardiac: left ventricular ejection fraction (LVEF) at rest ≥ 35% (RIC cohort) or

    LVEF at rest ≥ 40% (FIC cohort), or left ventricular shortening fraction (LVFS)

    ≥ 25%

    2. Pulmonary: diffusing capacity of the lungs for carbon monoxide (DLCO), forced

    expiratory volume (FEV1), forced vital capacity (FVC) ≥ 50% predicted by

    pulmonary function tests (PFTs)

    3. Hepatic: total bilirubin ≤ 2.5 mg/dL, and alanine aminotransferase (ALT),

    aspartate aminotransferase (AST), and alkaline phosphatase (ALP) < 5 x upper

    limit of (ULN) (unless disease related)

    4. Renal: serum creatinine (SCr) within normal range for age (see table 2.3). If

    SCr is outside normal range for age, creatinine clearance (CrCl) > 40

    mL/min/1.73m2 must be obtained (measured by 24-hour (hr) urine specimen or

    nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault

    formula for those aged ≥ 18 years; by Original Schwartz estimate for those < 18

    years))

    7. Subjects ≥ 18 years of age must have the ability to give informed consent according

    to applicable regulatory and local institutional requirements. Legal guardian

    permission must be obtained for subjects < 18 years of age. Pediatric subjects will

    be included in age appropriate discussion in order to obtain assent.

    8. Subjects with documentation of confirmed HIV-1 infection (i.e. HIV-positive), and a

    hematologic malignancy who meets all other eligibility requirements must:

    1. Receive only RIC regimen (i.e. Regimen A)

    2. Be willing to comply with effective antiretroviral therapy (ARV)

    3. Have achieved a sustained virologic response for 12 weeks after cessation of

    hepatitis C antiviral treatment (in HIV-positive subjects with hepatitis C)

    Exclusion Criteria:

    1. HLA-matched related or 8/8 allele matched (HLA-A, -B, -C, -DRB1) unrelated donor

    available. This exclusion does not apply to HIV-positive subjects who have a

    CCR5delta32 homozygous donor.

    2. Autologous HCT < 3 months prior to the time of signing the informed consent form

    3. Females who are breast-feeding or pregnant

    4. HIV-positive subjects:

    1. Acquired immunodeficiency syndrome (AIDS) related syndromes or symptoms that may

    pose an excessive risk for transplantation-related morbidity as determined by

    the Treatment Review Committee (see Appendix D).

    2. Untreatable HIV infection due to multidrug ARV resistance. Subjects with a

    detectable or standard viral load > 750 copies/mL should be evaluated with an

    HIV drug resistance test (HIV-1 genotype). The results should be included as

    part of the ARV review (described in Appendix D).

    3. May not be currently prescribed ritonavir, cobacistat and/or zidovudine

    5

    Exclusion Criteria:

    Inclusion Criteria:

    1. Age ≥ 15 years and < 71 years at the time of signing the informed consent form

    2. Partially HLA-mismatched unrelated donor: HLA typing will be performed at high

    resolution (allele level) for the HLA-A, -B, -C, and -DRB1 loci; a minimum match of

    4/8 at HLA-A, -B, -C, and -DRB1 is required

    3. Product planned for infusion is bone marrow

    4. Disease and disease status:

    1. Acute Leukemias or T lymphoblastic lymphoma in 1st or subsequent complete

    remission (CR): Acute lymphoblastic leukemia (ALL)/T lymphoblastic lymphoma;

    acute myelogenous leukemia (AML); acute biphenotypic leukemia (ABL); acute

    undifferentiated leukemia (AUL)

    2. Myelodysplastic Syndrome (MDS), fulfilling the following criteria: Subjects with

    de novo MDS who have or have previously had Intermediate-2 or High risk disease

    as determined by the International Prognostic Scoring System (IPSS). Current

    Intermediate-2 or High risk disease is not a requirement; Subjects must have <

    20% bone marrow blasts, assessed within 60 days of informed consent; Subjects

    may have received prior therapy for the treatment of MDS prior to enrollment

    3. Chronic Lymphocytic Leukemia (CLL) in CR if RIC is to be used; in CR or partial

    response (PR) if FIC is to be used

    4. Chemotherapy-sensitive lymphoma in status other than 1st CR

    5. Performance status: Karnofsky or Lansky score ≥ 60% (Appendix A)

    6. Adequate organ function defined as:

    1. Cardiac: left ventricular ejection fraction (LVEF) at rest ≥ 35% (RIC cohort) or

    LVEF at rest ≥ 40% (FIC cohort), or left ventricular shortening fraction (LVFS)

    ≥ 25%

    2. Pulmonary: diffusing capacity of the lungs for carbon monoxide (DLCO), forced

    expiratory volume (FEV1), forced vital capacity (FVC) ≥ 50% predicted by

    pulmonary function tests (PFTs)

    3. Hepatic: total bilirubin ≤ 2.5 mg/dL, and alanine aminotransferase (ALT),

    aspartate aminotransferase (AST), and alkaline phosphatase (ALP) < 5 x upper

    limit of (ULN) (unless disease related)

    4. Renal: serum creatinine (SCr) within normal range for age (see table 2.3). If

    SCr is outside normal range for age, creatinine clearance (CrCl) > 40

    mL/min/1.73m2 must be obtained (measured by 24-hour (hr) urine specimen or

    nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault

    formula for those aged ≥ 18 years; by Original Schwartz estimate for those < 18

    years))

    7. Subjects ≥ 18 years of age must have the ability to give informed consent according

    to applicable regulatory and local institutional requirements. Legal guardian

    permission must be obtained for subjects < 18 years of age. Pediatric subjects will

    be included in age appropriate discussion in order to obtain assent.

    8. Subjects with documentation of confirmed HIV-1 infection (i.e. HIV-positive), and a

    hematologic malignancy who meets all other eligibility requirements must:

    1. Receive only RIC regimen (i.e. Regimen A)

    2. Be willing to comply with effective antiretroviral therapy (ARV)

    3. Have achieved a sustained virologic response for 12 weeks after cessation of

    hepatitis C antiviral treatment (in HIV-positive subjects with hepatitis C)

    Exclusion Criteria:

    1. HLA-matched related or 8/8 allele matched (HLA-A, -B, -C, -DRB1) unrelated donor

    available. This exclusion does not apply to HIV-positive subjects who have a

    CCR5delta32 homozygous donor.

    2. Autologous HCT < 3 months prior to the time of signing the informed consent form

    3. Females who are breast-feeding or pregnant

    4. HIV-positive subjects:

    1. Acquired immunodeficiency syndrome (AIDS) related syndromes or symptoms that may

    pose an excessive risk for transplantation-related morbidity as determined by

    the Treatment Review Committee (see Appendix D).

    2. Untreatable HIV infection due to multidrug ARV resistance. Subjects with a

    detectable or standard viral load > 750 copies/mL should be evaluated with an

    HIV drug resistance test (HIV-1 genotype). The results should be included as

    part of the ARV review (described in Appendix D).

    3. May not be currently prescribed ritonavir, cobacistat and/or zidovudine

    5

    Learn More
  • open for enrollment

    Phase 2 Study Investigate Efficacy and Safety Cobomarsen (MRG-106) Subjects w/CTCL, MF Subtype

    Protocol: OSU-18244

    Principal Investigator: Basem M William, MD

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  • open for enrollment

    Ph2, Multi-Cohort Tr of Comb Nivo and Temozolomide in Recur/Refrac Sm Cell Lung Ca and Advanc Neuro

    Protocol: OSU-18184

    Principal Investigator: Dwight Owen, MD

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