drugset / Trial / NCT02432378
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines
Phase 1/2
Withdrawn
Roswell Park Cancer Institute
AIM ImmunoTech Inc. · collabNational Cancer Institute (NCI) · collabUniversity 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
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 |