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A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (Ad5-Delta 24 RGD)for Intraperitoneal Delivery in Ovarian and Extraovarian Cancer Patients (Infectivity Enhanced Virotherapy for Ovarian Cancer) (Ad5Delta24RGD)
The primary purpose of this study is to determine the maximally tolerated dose and spectrum of toxicities encountered with intraperitoneal delivery of a RGD modified conditionally replicative adenovirus (Ad5-Delta 24RGD) in patients with recurrent ovarian cancer. Secondary objectives : * To determine the biologic effects encountered with intraperitoneal delivery of Ad5-Delta 24RGD in patients with recurrent ovarian cancer cells * To determine immunologic response generated against Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma * To determine potential clinical activity of Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma
Details
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 26 |
| Start date | 2007-06 |
| Completion | 2010-06 |
Conditions
- Ovarian Cancer
- Primary Peritoneal Cancer
Interventions
- Tenckhoff Catheter placement
- Ad5-delta24RGD
Primary outcomes
- To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD — 1 month
Countries
United States