Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Cancer of Ovary, Cancer of the Ovary, Neoplasms, Ovarian, Ovarian Cancer, Ovary Cancer, Ovary Neoplasms

In brief

This study will evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and interferon-alpha (IFNα) for patients with advanced stage ovarian cancer (III-IV) at primary neoadjuvant setting. In the safety phase I phase, we determined the tolerable dose of IPC-CKM. In this phase 2 we will add intradermal (ID) autologous αDC1 vaccines (known to be nontoxic) to the tolerable IPC-CKM regimen. The effectiveness will be determined by rate of complete pathologic response.

Key facts

Study ID: NCT02432378
Run by: Roswell Park Cancer Institute
People needed: 0
Starts: 2015-09-04
Expected to finish: 2025-06-19
Last updated by the study team: 2026-07-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Patients must have advanced stage (III-IV) epithelial carcinoma of ovarian, tubal, or peritoneal origin.
Histologic documentation of the original primary tumor is required via the pathology report.
Original tumor blocks from primary diagnosis biopsy will be reviewed by our study pathologist at Magee.
Patients must be receiving neoadjuvant chemotherapy
Patients must be eligible for cancer-related definitive therapy with neoadjuvant chemotherapy
Patients must be chemonaive and receiving therapy in primary first line neoadjuvant setting
Patients must have GOG performance of 0-1
Patients must be reasonable candidates for interval debulking surgery as well as IP platinum based combination chemotherapy regimen with no prior evidence of clinically significant intra-abdominal adhesions, persistent abdominal wall infections, renal toxicity, or bowel obstruction.
Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to the first date of treatment on this study.
Patient must be willing to undergo leukapheresis
Patients must agree to appropriate clinical monitoring to receive the study regimens.
Patient must have:
Bone marrow function:
Absolute neutrophil count (ANC) greater than or equal to 1,500/µL, equivalent to CTCAE v4 grade 1.
Platelets greater than or equal to 100,000/µL;
hemoglobin greater than or equal to 8.0 g/dL.
Renal function:
creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4 grade 1.
Hepatic function:
Bilirubin less than or equal to 1.5 x ULN (CTCAE v4 grade 1).
SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4 grade 1).
Patients who have signed informed consent and authorization permitting release of personal health information.
Patients must have a GOG Performance Status of 0 or 1.
Exclusion Criteria:
Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis).

Where it is running

UPMC CancerCenter at Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
Hillman Cancer Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.