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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

    An Open-label, Phase 1b Study of ACP-196 Alone or in Combinatio in Subjects with Follicular Lymphoma

    Protocol: OSU-15029

    Principal Investigator: Beth A Christian, MD

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  • open for enrollment

    Pacritinib in Pts w/ Thrombocytopenia & Pri MF, Post-PV MF, or Post- ET MF Prev Tx w/ Ruxolitinib

    Protocol: OSU-17278

    Principal Investigator: Bhavana Bhatnagar, DO

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  • open for enrollment

    Itacitinib or Placebo in Combo w/ Corticosteroids for the Tx of First-Line Acute GVHD

    Protocol: OSU-17209

    Principal Investigator: Yvonne A Efebera, MD

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  • open for enrollment

    P2/3 Randomized Study of Toca 511 & Toca FC Versus SOC in Subjects Undergoing Surgery for Recurrent GBM/AA

    Protocol: OSU-15271

    Eligibility:

    Inclusion Criteria:

    Inclusion Criteria:

    1. Subject has given written informed consent

    2. Subject is between 18 years old and 75 years old, inclusive

    3. Subjects must have histologically proven GBM or AA in first or second recurrence

    (including this recurrence) or progression following initial definitive multimodal

    therapy with surgery, temozolomide (unless MGMT promoter unmethylated) and radiation

    (confirmed by diagnostic biopsy with local pathology review or contrast enhanced

    MRI). If first recurrence of GBM is documented by MRI, an interval of at least 12

    weeks after the end of prior radiation therapy is required unless there is either: i)

    histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI

    outside of the radiotherapy treatment field

    4. Subjects must have measurable disease preoperatively, defined as at least 1 contrast

    enhancing lesion, measuring at least 1 cm in 2 planes (axial, coronal, or sagittal)

    5. Subjects must be at least 4 weeks post last dose of temozolomide

    6. Prior gamma knife, stereotactic radiosurgery, or other focal high-dose radiotherapy

    is allowed but the subject must have either histopathologic confirmation of recurrent

    tumor, or new enhancement on MRI outside of the radiotherapy treatment field

    7. Based on the pre operative evaluation by neurosurgeon, the subject is a candidate for

    ≥ 80% resection of enhancing region

    8. IDH mutation status of the primary tumor must be available or tumor samples must be

    available for pre randomization testing

    9. Laboratory values adequate for patient to undergo surgery, including:

    Platelet count ≥ 60,000/mm3

    Hgb ≥ 10 g/dL

    Absolute neutrophil count (ANC) ≥ 1,500/mm3

    Absolute lymphocyte count (ALC) ≥ 500/mm3

    Adequate liver function, including:

    Total bilirubin ≤ 1.5 x ULN (unless has Gilbert's syndrome)

    ALT ≤ 2.5 x ULN f. Estimated glomerular filtration rate of at least 50

    mL/min by the Cockcroft Gault formula below:

    10. Women of childbearing potential (≥12 months of non-therapy-induced amenorrhea or

    surgically sterile) must have had a negative serum pregnancy test within the past 21

    days and must use a birth control method in addition to barrier methods (condoms).

    11. Subject or subject's partner is willing to use condoms for 12 months after receiving

    Toca 511 or until there is no evidence of the virus in his/her blood, whichever is

    longer.

    12. The subject has a KPS ≥ 70

    13. The subject is willing and able to abide by the protocol

    Exclusion Criteria:

    1. History of more than 2 prior recurrences (including this recurrence) of GBM or AA

    2. History of other malignancy, unless the patient has been disease free for at least 5

    years. Adequately treated basal cell carcinoma or squamous cell skin cancer is

    acceptable regardless of time, as well as localized prostate carcinoma or cervical

    carcinoma in situ after curative treatment

    3. Histological confirmed oligodendroglioma or mixed glioma

    4. Known 1p/19q co deletion

    5. A contrast enhancing brain tumor that is any of the following:

    Multi focal (defined as 2 separate areas of contrast enhancement measuring at

    least 1 cm in 2 planes that are not contiguous on either fluid attenuated

    inversion recovery (FLAIR) or T2 sequences);

    Associated with either diffuse subependymal or leptomeningeal dissemination; or

    > 5 cm in any dimension

    6. The subject has or had any active infection requiring antibiotic, antifungal or

    antiviral therapy within the past 4 weeks

    7. The subject has any bleeding diathesis, or must take anticoagulants, or antiplatelet

    agents, including nonsteroidal anti inflammatory drugs (NSAIDs), at the time of the

    scheduled resection that cannot be stopped for surgery

    8. The subject is HIV positive

    9. The subject has a history of allergy or intolerance to flucytosine

    10. The subject has a gastrointestinal disease that would prevent him or her from being

    able to swallow or absorb flucytosine

    11. The subject received cytotoxic chemotherapy within the past 4 weeks (6 weeks for

    nitrosoureas) of the planned surgery date

    12. The subject received any investigational treatment within the past 30 days or prior

    immunotherapy or antibody therapy within the past 4

    Exclusion Criteria:

    Inclusion Criteria:

    1. Subject has given written informed consent

    2. Subject is between 18 years old and 75 years old, inclusive

    3. Subjects must have histologically proven GBM or AA in first or second recurrence

    (including this recurrence) or progression following initial definitive multimodal

    therapy with surgery, temozolomide (unless MGMT promoter unmethylated) and radiation

    (confirmed by diagnostic biopsy with local pathology review or contrast enhanced

    MRI). If first recurrence of GBM is documented by MRI, an interval of at least 12

    weeks after the end of prior radiation therapy is required unless there is either: i)

    histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI

    outside of the radiotherapy treatment field

    4. Subjects must have measurable disease preoperatively, defined as at least 1 contrast

    enhancing lesion, measuring at least 1 cm in 2 planes (axial, coronal, or sagittal)

    5. Subjects must be at least 4 weeks post last dose of temozolomide

    6. Prior gamma knife, stereotactic radiosurgery, or other focal high-dose radiotherapy

    is allowed but the subject must have either histopathologic confirmation of recurrent

    tumor, or new enhancement on MRI outside of the radiotherapy treatment field

    7. Based on the pre operative evaluation by neurosurgeon, the subject is a candidate for

    ≥ 80% resection of enhancing region

    8. IDH mutation status of the primary tumor must be available or tumor samples must be

    available for pre randomization testing

    9. Laboratory values adequate for patient to undergo surgery, including:

    Platelet count ≥ 60,000/mm3

    Hgb ≥ 10 g/dL

    Absolute neutrophil count (ANC) ≥ 1,500/mm3

    Absolute lymphocyte count (ALC) ≥ 500/mm3

    Adequate liver function, including:

    Total bilirubin ≤ 1.5 x ULN (unless has Gilbert's syndrome)

    ALT ≤ 2.5 x ULN f. Estimated glomerular filtration rate of at least 50

    mL/min by the Cockcroft Gault formula below:

    10. Women of childbearing potential (≥12 months of non-therapy-induced amenorrhea or

    surgically sterile) must have had a negative serum pregnancy test within the past 21

    days and must use a birth control method in addition to barrier methods (condoms).

    11. Subject or subject's partner is willing to use condoms for 12 months after receiving

    Toca 511 or until there is no evidence of the virus in his/her blood, whichever is

    longer.

    12. The subject has a KPS ≥ 70

    13. The subject is willing and able to abide by the protocol

    Exclusion Criteria:

    1. History of more than 2 prior recurrences (including this recurrence) of GBM or AA

    2. History of other malignancy, unless the patient has been disease free for at least 5

    years. Adequately treated basal cell carcinoma or squamous cell skin cancer is

    acceptable regardless of time, as well as localized prostate carcinoma or cervical

    carcinoma in situ after curative treatment

    3. Histological confirmed oligodendroglioma or mixed glioma

    4. Known 1p/19q co deletion

    5. A contrast enhancing brain tumor that is any of the following:

    Multi focal (defined as 2 separate areas of contrast enhancement measuring at

    least 1 cm in 2 planes that are not contiguous on either fluid attenuated

    inversion recovery (FLAIR) or T2 sequences);

    Associated with either diffuse subependymal or leptomeningeal dissemination; or

    > 5 cm in any dimension

    6. The subject has or had any active infection requiring antibiotic, antifungal or

    antiviral therapy within the past 4 weeks

    7. The subject has any bleeding diathesis, or must take anticoagulants, or antiplatelet

    agents, including nonsteroidal anti inflammatory drugs (NSAIDs), at the time of the

    scheduled resection that cannot be stopped for surgery

    8. The subject is HIV positive

    9. The subject has a history of allergy or intolerance to flucytosine

    10. The subject has a gastrointestinal disease that would prevent him or her from being

    able to swallow or absorb flucytosine

    11. The subject received cytotoxic chemotherapy within the past 4 weeks (6 weeks for

    nitrosoureas) of the planned surgery date

    12. The subject received any investigational treatment within the past 30 days or prior

    immunotherapy or antibody therapy within the past 4

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  • open for enrollment

    Ph II Selumetinib for Advanced Pancreas Cancer harboring KRAS G12R Mutations

    Protocol: OSU-17376

    Principal Investigator: John L Hays, MD, PhD

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