This phase II trial studies how well recombinant interferon alfa-2b when given together with cisplatin, rintatolimod, celecoxib and vaccine therapy work in treating patients with ovarian cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Biological therapies, such as recombinant interferon alpha-2b, rintatolimod, and celecoxib, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from a persons white blood cells may help the body build an effective immune response to kill tumor cells. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. Giving chemotherapy, recombinant interferon alpha-2b, rintatolimod, celecoxib, and vaccine therapy may be a better treatment for ovarian cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02432378.
PRIMARY OBJECTIVES:
I. To assess the efficacy of chemo-immunotherapy combined with alpha-type-1 polarized dendritic cells (alphaDC) vaccine.
SECONDARY OBJECTIVES:
I. Monitoring of patient safety and adverse events.
II. Survival outcome as well as immunologic endpoints.
III. Progression-free survival and overall survival.
OUTLINE:
PHASE I (COMPLETED): Patients receive celecoxib orally (PO) once daily (QD) after intraperitoneal (IP) catheter placement up to 5 days (+2 days) prior to debulking surgery and continue after surgery when oral intake is allowed. Treatment with celecoxib repeats until cycle 6 day 9. Patients receive an additional dose celecoxib on the days of IP chemotherapy and chemokine modulatory regimen (CKM). Patients also receive cisplatin intraperitoneally (IP) over 1 hour on day 1, and recombinant interferon alpha-2b IP over 1 hour and rintatolimod IP over 1-2 hours on day 2 of cycles 2, 4, 5, 6 and day 9 of cycle 3. Within weeks 10-11, patients undergo debulking surgery. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
PHASE II:
TREATMENT: Patients undergo leukapheresis at baseline. Patients receive celecoxib PO twice daily (BID) on days 1-5 and QD on days 6-21 of cycles 1-8. Patients also receive paclitaxel over 3 hours intravenously (IV) on day 1, cisplatin IP over 1 hour on day 1, alpha-type-1 polarized dendritic cells intradermally (ID) on day 2 of cycles 2-8, recombinant interferon alpha-2b IP over 1 hour and rintatolimod IP over 1-2 hours on day 3. Patients undergo debulking surgery after completion of cycle 4 and before starting cycle 5. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive celecoxib PO BID on day 1 and QD on days 2-21 of each cycle, alpha-type-1 polarized dendritic cells ID on day 1, recombinant interferon alpha-2b IP over 1 hour and rintatolimod IP over 1-2 hours on day 1 of each cycle. Treatment repeats every 21 days for up to 9 cycles (6 moths) in the absence of disease progression or unacceptable toxicity.
All patients undergo biopsy, blood collection and computed tomography (CT) or CT/positron emission tomography (PET) throughout the study.
After completion of study treatment, patients are followed up every 3 months for 3 years.
Lead OrganizationRoswell Park Cancer Institute
Principal InvestigatorRobert P. Edwards
