INCB024360, Natural Killer Cells, and Aldesleukin after Preparative Chemotherapy in Treating Patients with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Inclusion Criteria

• Diagnosis of recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer that has failed or progressed after at least 1 prior salvage chemotherapy regimen directed at recurrent/metastatic disease
• Measurable disease per disease specific Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1-patients with bone as their only site of disease will not be eligible
• If history of brain metastases must be stable for at least 3 months after treatment-a brain computed tomography (CT) scan will only be required in subjects with known brain metastases at the time of enrollment or in subjects with clinical signs or symptoms suggestive of brain metastases
• Available related human leukocyte antigen (HLA)-haploidentical NK cell donor by at least class I serologic typing at the A&B locus
• Gynecologic Oncology Group (GOG) performance status >= 2
• Platelets >= 80,000 x 10^9/L, unsupported by transfusions
• Hemoglobin >= 9 g/dL, unsupported by transfusions
• Absolute neutrophil count (ANC) >= 1000 x 10^9/L, unsupported by filgrastim (G-CSF) or granulocytes
• Estimated glomerular filtration rate (GFR) of >= 50 ml/min (based on the Fairview Laboratories formula at time of screening)
• Total bilirubin < 1.5 times upper limit of institutional normal
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 3 times upper limit of institutional normal
• Alkaline phosphatase < 3 times upper limit of institutional normal
• Prothrombin time (PT)/international normalized ratio (INR) within institutional normal limits
• Left ventricular ejection fraction > 40% (within 28 days of treatment start)
• > 50% corrected diffusing capacity of the lung for carbon monoxide (DLCO), if presence of pleural effusion due to metastatic disease > 40% corrected DLCO is acceptable (within 28 days of treatment start)
• > 50% forced expiratory volume of the lung in 1 second (FEV1), if presence of pleural effusion due to metastatic disease > 40% corrected FEV1 is acceptable (within 28 days of treatment start)
• Able to be off prednisone or other immunosuppressive medications other than that prescribed per protocol for at least 3 days prior to day 0
• At least 14 days must lapse between last prior anti-cancer treatment and 1st day of preparative regimen
• Able to tolerate intraperitoneal (IP) port placement and IP treatment administration in the opinion of the enrolling investigator
• Voluntary written consent
• DONOR: Related donor (sibling, parent, offspring, parent or offspring of an HLA identical sibling) >= age 14 years (if < 18 years, > 40 kg)
• DONOR: In general good health in the opinion of the evaluating medical provider
• DONOR: Able and willing to undergo leukapheresis
• DONOR: HLA-haploidentical donor/recipient match by at least class I serologic typing at the A&B locus
• DONOR: Agree to undergo donor viral screening panel
• DONOR: Not pregnant
• DONOR: Voluntary written consent

Exclusion Criteria

• Active infection-must be afebrile and off antibiotics
• Requiring potent cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors
• Use of monoamine oxidase inhibitors (MAOI)s and selective serotonin reuptake inhibitor (SSRIs) within the last 4 weeks or history of serotonin syndrome
• Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs except in association with preparative regimen and NK cell infusion; any cyclooxygenase (COX)-2 inhibitors are permitted
• Concurrent systemic immunosuppressive therapy or steroid therapy with more than 7 consecutive days of steroids within the last 4 weeks except in association with preparative regimen and NK cell infusion-inhaled corticosteroids is permitted
• Prior therapy with anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, anti programmed cell death 1 (PD-1), or an experimental immune system-targeted therapy
• Use of any uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A9 (UGT1A9) inhibitor including: diclofenac, imipramine, ketoconazole, mefenamic acid, and probenecid from screening through follow-up period
• Undergone an organ transplant(s) including allogeneic stem cell or bone marrow transplants
• Unstable cardiovascular disease (eg, uncontrolled hypertension, peripheral vascular disease, congestive heart failure, cardiac arrhythmia, or acute coronary syndrome) within 6 months of starting study treatment
• Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome); unable or unwilling to swallow tablets BID
• Active autoimmune process (eg rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) or who have been receiving therapy for an autoimmune or inflammatory disease; vitiligo, thyroiditis, or eczema is permitted if patient is otherwise eligible
• Known human immunodeficiency virus (HIV)-positivity or other history of immunodeficiency disorder
• Cirrhosis or chronic hepatitis C virus positivity or chronic hepatitis B infection-a positive hepatitis B serology indicative or previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute hepatitis B virus (HBV) infection is not an exclusion criterion