Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines

Phase 1/2 Withdrawn Roswell Park Cancer Institute AIM ImmunoTech Inc. · collab National Cancer Institute (NCI) · collab University of Pittsburgh · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2015-09-04
Primary completion: 2025-06-19
Completion: 2025-06-19

Outcome

Outcome not reported

Stopped: “opening up at a different site”

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DC vaccine	Vaccine	—	Other
Subject	IFNα	Unknown	2e+06 iu	Other
Subject	IFNα	Unknown	6e+06 iu	Other
Subject	IFNα	Unknown	1.8e+07 iu	Other
Subject	Rintatolimod	Oligonucleotide (other)	200 mg	Other
Background	Celecoxib	Other / unclassified	200 mg	Oral
Background	Cisplatin	Other / unclassified	50 mg/m2	Other