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. Identifier: NCT00849290
Recruitment Status : Completed
First Posted : February 23, 2009
Results First Posted : October 11, 2010
Last Update Posted : March 14, 2013
Information provided by (Responsible Party):

February 19, 2009
February 23, 2009
May 28, 2010
October 11, 2010
March 14, 2013
April 2004
January 2009   (Final data collection date for primary outcome measure)
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 assess the safety of APC8015F [ Time Frame: periodically over 24 months ]
Complete list of historical versions of study NCT00849290 on Archive Site
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 assess the efficacy of APC8015F in delaying prostate specific antigen (PSA) doubling time (PSADT) and on overall clinical response [ Time Frame: periodically over 24 months ]
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Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
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This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Androgen Independent Prostate Cancer
Biological: APC8015F
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.
Experimental: APC8015F
Intervention: Biological: APC8015F
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2009
January 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Objective disease progression
  • Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442)

Exclusion Criteria:

  • Infection requiring IV antibiotics
  • Treatment with anticancer interventions within 14 days prior to enrollment
  • Any medical condition which could compromise the study's objectives (discretion from sponsor)
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Study Chair: Paul Schellhammer, MD Devine Tidewater Urology
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP