Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
|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: NCT00849290|
Recruitment Status : Completed
First Posted : February 23, 2009
Results First Posted : October 11, 2010
Last Update Posted : March 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Androgen Independent Prostate Cancer||Biological: APC8015F||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||April 2009|
APC8015F is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. APC8015F consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.
- Safety of APC8015F by Review of Reported Adverse Events [ Time Frame: periodically over 24 months ]All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events.
- To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response [ Time Frame: periodically over 24 months ]
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): NCT00849290
Show 58 Study Locations
|Study Chair:||Paul Schellhammer, MD||Devine Tidewater Urology|