Autologous OC-DC Vaccine in Ovarian Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|