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Treatment of Ovarian Carcinoma With DNP-Modified Autologous Tumor Vaccine
NCT00003386Phase 2
Key facts
- Status
- Terminated
- Start
- Jul 1999
- Primary completion
- Apr 2001
- Countries
- 2
- Sponsor
- GOG Foundation
- Modality
- Cell Therapies, Vaccines & Immunotherapeutics
- Conditions
- ovarian cancer
01
Overview
Phase 2, open-label, single-arm trial of autologous DNP-modified vaccine in ovarian cancer, sponsored by GOG Foundation. Primary endpoints: Delayed-type hypersensitivity to dinitrophenyl-modified autologous tumor vaccine at week 8, Toxic effects of the regimen up to 5 years and 1 more. Started Jul 1999; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Vaccine Therapy
Patients receive DNP-modified autologous tumor vaccine with BCG adjuvant and cyclophosphamide after surgery and chemotherapy.
03
Who it enrols
Patients with surgically debulked stage III or IV ovarian epithelial cancer who are clinically tumor-free following 6 courses of paclitaxel and platinum-based chemotherapy.
04
Endpoints
Primary
Delayed-type hypersensitivity to dinitrophenyl-modified autologous tumor vaccine
Toxic effects of the regimen
Feasibility of conducting a group wide vaccine study
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