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NCT00849290 Clinical Trial

Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)

Metastatic Androgen Independent Prostate Cancer Clinical Trial

Official title:
AN OPEN LABEL, SINGLE ARM TRIAL OF IMMUNOTHERAPY WITH AUTOLOGOUS ANTIGEN PRESENTING CELLS LOADED WITH PA2024 (APC8015F) FOR MEN WITH OBJECTIVE DISEASE PROGRESSION ON PROTOCOL D9902 PART B

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00849290
Other study ID # PB01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2004
Est. completion date April 2009

Study information
Verified date September 2021
Source Dendreon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Other known NCT identifiers
  • NCT00090922
  • NCT00170066
  • NCT00513006

Recruitment information / eligibility
Status Completed
Enrollment 113
Est. completion date April 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Canada London Health Sciences Centre London Ontario
Canada Hospital Notre Dame du CHUM Montreal Quebec
Canada Princess Margaret Hospital Toronto Ontario
Canada Sunnybrook & Women's College HSC Toronto Ontario
Canada Can-Med Medical Research, Inc. Victoria British Columbia
United States Albany Regional Cancer Center Albany New York
United States The Urological Institute of Northeastern New York Albany New York
United States Georgia Urology, P.A. Atlanta Georgia
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Center for Urologic Care Bryn Mawr Pennsylvania
United States Lahey Clinic (Department of Urology) Burlington Massachusetts
United States McKay Urology Charlotte North Carolina
United States Midwest Prostate & Urology Health Center Chicago Illinois
United States University of Cincinnati Cincinnati Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Mary Crowley Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States North Shore Hematology Oncology Associates East Setauket New York
United States Myron I Murdock MD LLC Greenbelt Maryland
United States Hackensack University Medical Center Hackensack New Jersey
United States New York Medical College Hawthorne New York
United States Baylor College of Medicine Houston Texas
United States Indiana University Indianapolis Indiana
United States Nevada Cancer Institute Las Vegas Nevada
United States UCLA Los Angeles California
United States USC Keck School of Medicine Los Angeles California
United States University of Wisconsin Madison Wisconsin
United States University of Wisconsin, Madison Madison Wisconsin
United States Loyola University Maywood Illinois
United States Miami Cancer Center Miami Florida
United States St. Luke's Hospital Immunotherapy Program Milwaukee Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States Grand Strand Urology Myrtle Beach South Carolina
United States Beth Israel Cancer Center New York New York
United States Clinical Cancer Center New York New York
United States Mount Sinai School of Medicine New York New York
United States New York University New York New York
United States Helen F. Graham Cancer Center Newark Delaware
United States Urology of Virginia, PC Norfolk Virginia
United States Lutheran General Cancer Center Park Ridge Illinois
United States Jefferson Medical College Philadelphia Pennsylvania
United States Hematology/Oncology Associates of the Treasure Coast Port Saint Lucie Florida
United States EACRI Portland Oregon
United States Kaiser Permanente Medical Group Portland Oregon
United States Mayo Clinic Rochester Minnesota
United States Sutter Cancer Center Sacramento California
United States University of Utah Salt Lake City Utah
United States Kaiser Permanente Medical Group San Diego California
United States Sharp HealthCare San Diego California
United States UCSF Cancer Center San Francisco California
United States Seattle Cancer Care Alliance Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States Cancer Care Northwest Spokane Washington
United States Staten Island Urological Research Staten Island New York
United States Lombardi Cancer Center Washington District of Columbia
United States Walter Reid Army Medical Center Washington District of Columbia
United States Wenatchee Valley Medical Center Wenatchee Washington
United States Associates in Urology, LLC West Orange New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Dendreon

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of APC8015F by Review of Reported Adverse Events 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. periodically over 24 months

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