Autologous OC-DC Vaccine in Ovarian Cancer
This is a three cohort sequential clinical trial for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone or in combination with intravenous Bevacizumab and Cyclophosphamide.
|Study Design:||Endpoint Classification: Safety Study
Primary Purpose: Treatment
|Official Title:||A Pilot Clinical Trial of Dendritic Cell Vaccine Loaded With Autologous Tumor for Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer|
- Safety [ Time Frame: 30 days of last vaccination ] [ Designated as safety issue: Yes ]Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version3.0). All toxicities observed within 30 days of last vaccination will be included.
- Clinical Response [ Designated as safety issue: Yes ]Clinical Response will be determined by RECIST criteria. Response rate is the proportion of patients that achieve CR or PR.
- Dose limiting toxicity [ Designated as safety issue: Yes ]Dose-limiting toxicity is defined as: any Grade 3 or higher allergic, autoimmune or injection site reaction or any Grade 4 hematologic or non-hematologic toxicity (except fever).
- Immune Response Immune Response [ Designated as safety issue: Yes ]Immune response will be evaluated by IFN-g ELISPOT analysis of tumor-reactive T cells, and in HLAA2+ subjects, by tetramer analysis of Her-2 specific T cells in peripheral blood. Response is defined by a 3 fold increase relative to pre-vaccination.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132014
|Contact: Clinical Team||215-615-7447||OCRC.Trials@uphs.upenn.edu|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Clinical Team 215-615-7447 OCRC.Trials@uphs.upenn.edu|
|Principal Investigator: Janos Tanyi, MD|
|Principal Investigator:||Janos Tanyi, MD||Abramson Cancer Center of the University of Pennsylvania|