drugset / Trial / NCT01312376
Autologous T-Cells Combined With Autologous OC-DC Vaccine in Ovarian Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a phase-I clinical trial to determine the feasibility and safety of Cyclophosphamide/Fludarabine Lymphodepletion and an immunomodulatory combination of Interferon-alpha Bevacizumab and Aspirin followed by adoptive transfer of vaccine-primed ex vivo CD3/CD28-costimulated peripheral blood autologous T cells and vaccination with whole tumor vaccine administered intradermally in combination with Bevacizumab in patients with recurrent ovarian cancer fallopian tube or primary peritoneal cancer. (Funding Source - FDA OOPD)
Timeline
- Start
- 2011-03
- Primary completion
- 2015-10
- Completion
- 2019-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | OC-DC vaccine | Vaccine | 5e+06 cells | Other |
| Subject | OC-DC vaccine | Vaccine | 1e+07 cells | Other |
| Subject | therapeutic autologous lymphocytes | Cell therapy | 1e+10 cells | Intravenous |
| Subject | therapeutic autologous lymphocytes | Cell therapy | 1.5e+10 cells | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |