Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer

This phase I/II trial tests the safety, side effects and best dose of a combination therapy (niraparib and selenium) in treating patients with BRCA negative ovarian cancer that has come back (recurrent) and does not respond to platinum based therapy (platinum resistant). Selenium is a form of the trace element with potential antineoplastic activity which may help block the formation of growths that may become cancer. Niraparib is in a class of medications called poly (ADP-ribose) polymerase inhibitors. It works by killing cancer cells and helps maintain the response of certain types of ovarian, fallopian tube and peritoneal cancers. Giving selenium and niraparib may kill more cells in patients with ovarian cancer.

Inclusion Criteria:Documented informed consent of the participant and/or legally authorized representativeAssent, when appropriate, will be obtained per institutional guidelinesAgreement to allow the use of archival tissue from biopsy or tissue block cytology obtained at time of last disease recurrence. If biopsy is not possible or patient refuses, the principal investigator (PI) may allow an earlier biopsy to be tested. If unavailable, exceptions may be granted with Study PI approvalAge: >= 18 yearsEastern cooperative oncology group (ECOG) =< 2Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer. May not have non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors or small cell carcinoma tumors or low grade serous carcinomaRecurrent, platinum resistant disease (defined as progression within <6 months from completion of platinum-based therapy. The date should be calculated from the last administered dose of platinum therapy)Measurable disease per response evaluation criteria in solid tumors (RECIST) 1.1 or evaluable 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 CA125 >2x upper limit of normal [ULN])No more than 4 prior cytotoxic regimens (including primary therapy). Hormonal therapies (tamoxifen, aromatase inhibitors) or other prior poly (ADP-Ribose) polymerase (PARP) inhibitors will not count toward the prior regimen limit. Prior PARP inhibotor therapy is allowedFully recovered from the acute toxic effects (except alopecia) to =< Grade 1 to prior anti-cancer therapyMyChoice HRD test should show BRCA wt and no HRD. No deleterious germline BRCA 1/2 mutations are allowedAbsolute neutrophil count (ANC) >= 1,500/mm^3 (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)Platelets >= 150,000/mm^3 (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)Total bilirubin =< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease, when =< 2.0 X ULN is acceptable (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)Aspartate aminotransferase (AST) =< 2.5 x ULN, unless liver metastases are present, in which case =< 5 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)Alanine aminotransferase (ALT) =< 2.5 x ULN, unless liver metastases are present, in which case =< 5 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)Serum Creatinine =< 1.5 x ULN or creatine clearance of >= 60 mL/min per 24 hour urine test or the Cockcroft-Gault formula (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)Prothrombin (PT) =< 1.25 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)Hemoglobin >= 9 g/dL (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)Women of childbearing potential (WOCBP): negative highly sensitive urine or serum pregnancy test (highly sensitive urine test will be required if serum pregnancy test is not available) (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)Normal blood pressure or adequately controlled hypertension (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated)Agreement by subjects of childbearing potential* to use a highly effective method of birth control or abstain from heterosexual activity for the course of the study through at least 180 days after the last dose of protocol therapyChildbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)Exclusion Criteria:Chemotherapy, biological therapy, immunotherapy within 21 days prior to Day 1 of protocolRadiation therapy encompassing > 20% of the bone marrow within 2 weeks. Any radiation therapy within 1 week prior to Day 1 therapyColony-stimulating factors (e.g. granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin within 4 weeks prior to day 1Receipt of a transfusion (platelets or red blood cells) within 4 weeks of D1Known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatmentDiagnosis, detection, or treatment of another type of cancer ≤ 2 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer in situ that has been definitively treatedStrong CYP3A4 inducers/ inhibitors within 14 days prior to Day 1 of protocol therapyUGT1A1 inhibitors within 14 days prior to Day 1 of protocol therapyHerbal medications containing selenium within 14 days prior to Day 1 of protocol therapyVitamin E within 14 days prior to Day 1 of protocol therapyAnticoagulants within 14 days prior to Day 1 of protocol therapy or active thromboembolism. The use of ASA or NSAIDS is allowedLive vaccines within 14 days prior to the first dose of study treatment. Seasonal flu vaccines that do not contain live viruses are allowed. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, bacille Calmette Guerin, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed. Intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowedHistory of allergic reactions attributed to compounds of similar chemical or biologic composition (including aluminum) to study agentHypersensitivity to any study agent, or its excipients, when administered aloneHistory of Posterior Reversible Encephalopathy Syndrome (PRES)Issues with tolerating oral medication (e.g. inability to swallow pills, malabsorption issues, ongoing nausea or vomiting)Active diarrheaClinically significant uncontrolled illness or medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric order that prohibits obtaining informed consentKnown history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infectionOther active malignancyFemales only: Pregnant or breastfeedingMajor surgery (other than debulking or exploratory surgery for ovarian cancer) for any reason within 3 weeks prior to randomization and/or incomplete recovery from surgeryPrior organ transplantation including allogenic stem cell transplantationDiagnosis of Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)Known leptomeningeal disease, carcinomatous meningitis, or radiologic signs of CNS hemorrhage. Known symptomatic brain metastases requiring steroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stableActive infectionsAny other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study proceduresPatients must not have uncontrolled hypertension as defined by systolic blood pressure (SBP) >= 160mmHg or diastolic blood pressure (DBP) >= 90mmHg; patients whose blood pressure can be controlled medically are allowed to be rescreened once BP is under controlProspective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)