This phase I/II trial studies the side effects and best dose of recombinant interferon alfa when given together with a dendritic cell vaccine, rintatolimod, and celecoxib after surgery in treating patients with cancer on the surface of the peritoneum that spread from the appendix, colon, or rectum. Vaccines made from a person's dendritic cells (a type of white blood cells) mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Recombinant interferon alfa may improve the body's natural response to infections and other diseases. It may also interfere with the division of tumor cells and growth of tumors. Celecoxib and rintatolimod may help stimulate the immune system. Giving a dendritic cell vaccine, recombinant interferon alfa, celecoxib, and rintatolimod together may help stimulate the immune system to kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02151448.
PRIMARY OBJECTIVES:
I. To test whether the combined immunotherapy regimen (alpha DC1 [alpha-type-1 polarized dendritic cells] vaccines + chemokine modulation regimen [CKM]) is safe and whether it can prolong time-to-progression (TTP) in patients with peritoneal surface malignancies after optimal cytoreductive surgery (CRS) + hyperthermic intraperitoneal chemotherapy (HIPEC) with standard of care chemotherapy.
SECONDARY OBJECTIVES:
I. To estimate overall survival (OS).
II. Perform correlative studies to characterize sequential immune response changes by quantitative measures of immune cellular phenotypes and chemokine patterns in delayed-type hypersensitivity (DTH) biopsy specimens (DTH to autologous tumor lysates) and peripheral blood.
OUTLINE: This is a phase I, dose-escalation study of recombinant interferon alfa followed by a phase II study.
Beginning on the day of discharge from surgery, patients receive celecoxib orally (PO) once daily (QD) on weeks 1-3, 21-23, and after week 24.
Patients receive 4 courses of alpha-type-1 polarized dendritic cell vaccinations (comprising 1 intradonal and 1 intradermal injection) on Monday of weeks 1, 4, 20, and 24. On courses 2- 4 (weeks 4, 20, and 24), patients also receive recombinant interferon alfa intravenously (IV) over 20 minutes on Tuesday-Friday and rintatolimod IV over 120 minutes on Wednesday and Friday. Patients receive celecoxib PO twice daily (BID) during courses 1-4 on the days of vaccination.
Patients rest on weeks 5-19 and undergo adjuvant chemotherapy if clinically necessary
After completion of study treatment, patients are followed up periodically.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorDavid L Bartlett