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.
On Phase 1, patients received up to 6 cycles of IPC, with CKM after the 2nd to 6th cycles. On Phase 2, (which opened 8/27/24/ )patients will receive up to 6 -8 cycles of chemotherapy with ID injections of DC1 vaccine with CKM. To optimize the pattern of immunity, all patients will also receive oral celecoxib (COX2 inhibitor).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Cisplatin 50 mg/m2 by IP once per cycle (21 days) + celecoxib daily 200 mg by mouth daily + intranodal vaccine injections once per cycle
Cisplatin 50 mg/m2 by IP once per cycle (21 days) + celecoxib daily 200 mg by mouth daily + IFN by IP once per cycle + rintatolimod 200 mg by IP once per cycle + intranodal vaccine injections once per cycle
UPMC CancerCenter at Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Change in the number of CD8+ tumor infiltrating T cells in the peritoneal fluid.
The difference in CD8+ tumor infiltrating T cells over 3 cycles of platinum based chemotherapy plus immunotherapy compared with baseline.
Time frame: 8 weeks
Number of adverse events for the different combinations
2 patients will be treated and observed for 2 cycles on each of the dose tiers to identify the acceptable dose of IFN in combination with the other protocol drugs/vaccine for the second phase of the trial.
Time frame: 8 weeks
Change in the number of CD3+CD8+ T cells in the peritoneal fluid.
Time frame: 8 weeks
Change in the number of effector CD8+ T cells in the peritoneal fluid.
Time frame: 8 weeks
Change in the number of CD4+ T cells in the peritoneal fluid.
Time frame: 8 weeks
Change in the number of Tregs in the peritoneal fluid.
Time frame: 8 weeks
Change in the number of myeloid-derived suppressor cells in the peritoneal fluid.
Time frame: 8 weeks
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