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A PHASE 2 EFFICACY TRIAL OF INTENSIVE LOCOREGIONAL CHEMOIMMUNOTHERAPY FOR ADVANCED STAGE OVARIAN CANCER AND TUMOR-SPECIFIC INTRANODAL AUTOLOGOUS ALPHA-DC1 VACCINES
Sponsor study identifier
Secondary identifiers
NIH
interventional
0
1 country
2
Study Start
September 4, 2015
Actual (reported)Primary Completion
June 19, 2025
Actual (reported)Study Completion
June 19, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 19, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 8, 2015
Actual (reported)May 4, 2015
Actual (reported)September 4, 2015
Actual (reported)June 19, 2025
Actual (reported)June 19, 2025
Actual (reported)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.
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.
8 weeks
Change in the number of CD3+CD8+ T cells in the peritoneal fluid.
8 weeks
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
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
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Cisplatin + celecoxib + DC vaccine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Cisplatin + CKM + Celecoxib + DC Vaccine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordUPMC CancerCenter at Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Orr B, Mahdi H, Fang Y, Strange M, Uygun I, Rana M, Zhang L, Suarez Mora A, Pusateri A, Elishaev E, Kang C, Tseng G, Gooding W, Edwards RP, Kalinski P, Vlad AM. Phase I Trial Combining Chemokine-Targeting with Loco-Regional Chemoimmunotherapy for Recurrent, Platinum-Sensitive Ovarian Cancer Shows Induction of CXCR3 Ligands and Markers of Type 1 Immunity. Clin Cancer Res. 2022 May 13;28(10):2038-2049. doi: 10.1158/1078-0432.CCR-21-3659.
Robert P Edwards, MD
University of Pittsburgh
0 participants (actual enrollment reported by the registry).
First Submitted
April 8, 2015
First Posted
May 4, 2015
Study Start
September 4, 2015
Actual (reported)Primary Completion
Change in the number of effector CD8+ T cells in the peritoneal fluid.
8 weeks
Change in the number of CD4+ T cells in the peritoneal fluid.
8 weeks
Change in the number of Tregs in the peritoneal fluid.
8 weeks
Change in the number of myeloid-derived suppressor cells in the peritoneal fluid.
8 weeks
Change in the number of TH1 cells in the peritoneal fluid.
8 weeks
Change in the number of natural killer cells in the peritoneal fluid.
8 weeks
Change in the number of dendritic cells in the peritoneal fluid.
8 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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June 19, 2025
Actual (reported)Study Completion
June 19, 2025
Actual (reported)Last Updated
July 8, 2026
Record last verified: 2026-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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