Autologous OC-DC Vaccine in Ovarian Cancer
This is a Five 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 or in combination with intravenous Bevacizumab, cyclophosphamide and aspirin. Study duration is 24 months.
|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|