We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Dendreon

Brief Summary:
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)

Condition or disease Intervention/treatment Phase
Metastatic Androgen Independent Prostate Cancer Biological: APC8015F Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2004
Primary Completion Date : January 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: APC8015F 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response [ Time Frame: periodically over 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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
Sponsors and Collaborators
Dendreon
Investigators
Study Chair: Paul Schellhammer, MD Devine Tidewater Urology

Additional Information:
Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT00849290     History of Changes
Obsolete Identifiers: NCT00090922, NCT00170066, NCT00513006
Other Study ID Numbers: PB01
First Posted: February 23, 2009    Key Record Dates
Results First Posted: October 11, 2010
Last Update Posted: March 14, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases