Autologous OC-DC Vaccine in Ovarian Cancer
|ClinicalTrials.gov Identifier: NCT01132014|
Recruitment Status : Unknown
Verified February 2016 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was: Active, not recruiting
First Posted : May 27, 2010
Last Update Posted : February 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy Tumor Ovarian Cancer||Biological: OCDC||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Official Title:||A Pilot Clinical Trial of Dendritic Cell Vaccine Loaded With Autologous Tumor for Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer|
|Study Start Date :||May 2010|
|Primary Completion Date :||July 2015|
- Safety [ Time Frame: 30 days of last vaccination ]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 ResponseClinical Response will be determined by RECIST criteria. Response rate is the proportion of patients that achieve CR or PR.
- Dose limiting toxicityDose-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 ResponseImmune 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132014
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Janos Tanyi, MD||Abramson Cancer Center of the University of Pennsylvania|