drugset / Trial / NCT01312376

Autologous T-Cells Combined With Autologous OC-DC Vaccine in Ovarian Cancer

NCT01312376

Phase 1 Terminated 18 enrolled Abramson Cancer Center at Penn Medicine
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

EvaluationDrugModalityDoseRoute
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