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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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    Study Ovarian Ca Pts Evaluating Rucaparib and Nivo Rx Following Response Platinum-Based Chemo

    Protocol: OSU-18133

    Principal Investigator: David M O'Malley, MD

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    Cediranib Maleate and Olaparib or Standard Chemotherapy in Treating Patients with Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Protocol: NRG-GY005

    Eligibility:

    Inclusion Criteria:

    Patients must have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of either serous or endometrioid cancer based on local histopathological findings; both endometrioid and serous histology should be high-grade for eligibility of non-mutation carriers; patients with clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma histologies are also eligible, provided that the patient has a known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory

    Patients should have recurrent platinum-resistant or- refractory disease - defined as disease that has progressed by imaging while receiving platinum or had recurrence within 6 months of the last receipt of platinum-based chemotherapy; rising CA125 only is not considered as platinum-resistant or refractory disease

    Phase II study: measurable disease by RECIST 1.1 criteria; if archival tumor sample is not available tumor sample from fresh biopsy is acceptable

    Phase III study: evaluable disease - defined as RECIST 1.1 measurable disease OR non-measurable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related in the setting of a cancer antigen [CA]125 >= 2 x upper limit of normal [ULN])

    No more than 3 prior treatment regimens (including primary therapy; no more than 1 prior non-platinum based therapy in the platinum-resistant/-refractory setting); hormonal therapies used as single agents (i.e. tamoxifen, aromatase inhibitors) will not count towards this line limit

    Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed

    Patients may not have previously received a PARP-inhibitor

    Patient must have provided study specific informed consent prior to study entry

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

    Absolute neutrophil count >= 1,500/mcL

    Platelets >= 100,000/mcL

    Hemoglobin >= 10 g/dL

    Total bilirubin within =< 1.5 times the upper limit of normal (ULN) institutional limits

    Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN

    Creatinine =< 1.5 x the institutional ULN

    Urine protein: creatinine ratio urine protein creatinine (UPC) of =< 1 OR less than or equal to 2+ proteinuria on two consecutive dipsticks taken no less than 1 week apart; UPC is the preferred test; patients with 2+ proteinuria on dipstick must also have a 24-hour urine collection demonstrating protein of =< 500 mg over 24 hours

    Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE v 4.0

    Adequately controlled blood pressure (systolic blood pressure [SBP] =< 140; diastolic blood pressure [DBP] =< 90 mmHg) on maximum of three antihypertensive medications; patients must have a BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients who are on three antihypertensive medications must be actively followed by a cardiologist or a primary care physician for management of BP while on protocol; patients must be willing and able to check and record daily blood pressure readings; blood pressure cuffs will be provided to patients randomized to cediranib alone and the combination of olaparib and cediranib arms

    Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid-stimulating hormone (TSH) within normal limits

    Able to swallow and retain oral medications and without gastrointestinal (GI) illnesses that would preclude absorption of cediranib or olaparib

    Women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 weeks after cediranib discontinuation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

    Women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential must agree to use must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months after the last dose of olaparib; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

    Exclusion Criteria:

    Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of starting treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients may not have had hormonal therapy within 2 weeks prior to entering the study; patients receiving raloxifene for bone health as per Food and Drug Administration (FDA) indication may remain on raloxifene absent other drug interactions

    Any other investigational agents within the past 4 weeks

    Prior treatment affecting the VEGF/VEGFR pathway or the angiopoietin pathway in the recurrent setting, including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, pazopanib, cediranib, nintedanib, and trebananib;bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed

    Prior use of PARP-inhibitors

    CA-125 only disease without Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable or otherwise evaluable disease

    Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib

    Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs

    History of intra-abdominal abscess within the past 3 months

    History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula

    Dependency on IV hydration or total parenteral nutrition (TPN)

    Any concomitant or prior invasive malignancies with the following curatively treated exceptions:

    Treated limited stage basal cell or squamous cell carcinoma of the skin

    Carcinoma in situ of the breast or cervix

    Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous/serous, clear cell, or other Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions

    Prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence

    Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should not be included on this study, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events; patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study drug

    Patients with any of the following:

    History of myocardial infarction within six months

    Unstable angina

    Resting electrocardiogram (ECG) with clinically significant abnormal findings

    New York Heart Association functional classification of III or IV

    If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines

    Patients with the following risk factors should have a baseline cardiac function assessment:

    • Prior treatment with anthracyclines
    • Prior treatment with trastuzumab
    • Prior central thoracic radiation therapy (RT), including RT to the heart
    • History of myocardial infarction within 6 to 12 months (Patients with history of myocardial infarction within 6 months are excluded from the study)
    • Prior history of impaired cardiac function

    History of stroke or transient ischemic attack within six months

    Clinical significant peripheral vascular disease or vascular disease (aortic aneurysm or aortic dissection)

    Evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted

    Evidence suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated

    No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)

    Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies

    Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than atrial fibrillation with controlled ventricular rate), or psychiatric illness/social situations that would limit compliance with study requirements

    Known human immunodeficiency virus (HIV)-positive individuals are ineligible

    Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible

    Strong inhibitors and inducers of UGT/PgP should be used with caution

    Pregnant women are excluded from this study

    Principal Investigator: Floor J Backes, MD

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  • open for enrollment

    Efficacy/Safety DKN-01 Monotherapy or w/Paclitaxel Patients w/Recurrent Epi Endometrial or Epi Ovari

    Protocol: OSU-18176

    Principal Investigator: David M O'Malley, MD

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    Ph I IMGN853 & rucaparib for recurrent endometrial, ovarian, fallopian tube or primary peritoneal ca

    Protocol: OSU-18007

    Principal Investigator: Floor J Backes, MD

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    Compassionate Use of Pimasertib in Patients with Recurrent Low Grade Ovarian Cancer

    Protocol: OSU-17336

    Principal Investigator: David M O'Malley, MD

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    Ph II Atezolizumab (MPDL3280A), SGI-110 and CDX-1401 Vaccine in Recurrent Ovarian Cancer

    Protocol: OSU-17306

    Principal Investigator: David M O'Malley, MD

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    Combo of Olaparib & Tremelimumab, in BRCA1 & BRCA2 Mut Carriers w/ Recurr Ovarian Cancer

    Protocol: OSU-17352

    Principal Investigator: David M O'Malley, MD

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    Ph 1/II REGN4018 Adm Alone/ Comb w/Cemiplimab in Pts w/ Platinum-Resistant Ovarian Ca

    Protocol: OSU-18027

    Principal Investigator: David M O'Malley, MD

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    Tisotumab Vedotin Patients w/ Platinum-Resistant Ovarian Ca w/ a Safety Run-in of Dose-Dense Regimen

    Protocol: OSU-18220

    Principal Investigator: David M O'Malley, MD

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  • open for enrollment

    Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients with Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors

    Protocol: GOG-0264

    Eligibility:

    Inclusion Criteria:

    Patients with histologically confirmed ovarian stromal tumor [granulosa cell tumor, ganulosa cell-theca cell tumor, Sertoli-Leydig cell tumor (androblastoma), steroid (lipid) cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules]

    Patients must have newly diagnosed, stage IIA – IV disease and must be entered within eight weeks from surgery; they may have either measurable residual disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria, or they may have no measurable residual disease; OR, they must have biopsy-proven recurrent disease of any stage and have never received cytotoxic chemotherapy

    Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2

    Patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control

    Patients in the measureable disease cohort must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as “non-target” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy

    Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Terminology Criteria for Adverse Events (CTCAE) grade 1

    Platelet greater than or equal to 100,000/mcl

    Creatinine no greater than the institutional upper limits of normal

    Bilirubin less than or equal to 1.5 x upper limit of normal (ULN) (CTCAE grade 1)

    Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3.0 x ULN (CTCAE grade 1)

    Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1)

    Neuropathy (sensory and motor) less than or equal to CTCAE grade 1

    No signs of clinically significant hearing loss

    Patients must have signed an approved informed consent and authorization permitting release of personal health information

    Patients must have pulmonary function sufficient to receive bleomycin, with normal lung expansion, absence of crackles on auscultation, and normal carbon monoxide diffusion (DLCO), defined as greater than 80% predicted

    Patients with a history of hypersensitivity reactions to prior chemotherapy administered for previous cancer diagnoses are eligible to participate in the study, unless the hypersensitivity reaction consisted of anaphylaxis not amenable to desensitization

    Recovery from effects of recent surgery, radiotherapy, or chemotherapy

    Patients must be entered within 8 weeks after surgery performed for either 1) initial diagnosis, staging, and/or cytoreduction, or 2) (if done) management of recurrent disease in a chemonaive patient

    Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted

    Exclusion Criteria:

    Patients who have received any prior cytotoxic chemotherapy or biologics for sex cord-stromal tumors (SCSTs)

    Patients with apparent stage I disease who have not undergone a staging procedure

    Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years

    Woman who are pregnant or breastfeeding

    Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator can consult the study chair or study co-chairs for uncertainty in this regard

    Principal Investigator: Floor J Backes, MD

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