Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
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
1 other identifier
interventional
113
2 countries
58
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2004
Longer than P75 for phase_2
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 19, 2009
CompletedFirst Posted
Study publicly available on registry
February 23, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
October 11, 2010
CompletedNovember 29, 2023
September 1, 2021
4.8 years
February 19, 2009
May 28, 2010
November 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
APC8015F
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Objective disease progression
- Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dendreonlead
Study Sites (58)
UCLA
Los Angeles, California, United States
USC Keck School of Medicine
Los Angeles, California, United States
Sutter Cancer Center
Sacramento, California, 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
Helen F. Graham Cancer Center
Newark, Delaware, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Walter Reid Army Medical Center
Washington D.C., District of Columbia, United States
Miami Cancer Center
Miami, Florida, United States
Hematology/Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
Georgia Urology, P.A.
Atlanta, Georgia, United States
Midwest Prostate & Urology Health Center
Chicago, Illinois, United States
Loyola University
Maywood, Illinois, United States
Lutheran General Cancer Center
Park Ridge, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Myron I Murdock MD LLC
Greenbelt, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Lahey Clinic (Department of Urology)
Burlington, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Associates in Urology, LLC
West Orange, New Jersey, United States
Albany Regional Cancer Center
Albany, New York, United States
The Urological Institute of Northeastern New York
Albany, New York, United States
North Shore Hematology Oncology Associates
East Setauket, New York, United States
New York Medical College
Hawthorne, New York, 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
Staten Island Urological Research
Staten Island, New York, United States
McKay Urology
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
EACRI
Portland, Oregon, United States
Kaiser Permanente Medical Group
Portland, Oregon, United States
Center for Urologic Care
Bryn Mawr, Pennsylvania, United States
Jefferson Medical College
Philadelphia, Pennsylvania, United States
Grand Strand Urology
Myrtle Beach, South Carolina, United States
Mary Crowley
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Urology of Virginia, PC
Norfolk, Virginia, 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
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
University of Wisconsin, Madison
Madison, Wisconsin, United States
University of Wisconsin
Madison, Wisconsin, United States
St. Luke's Hospital Immunotherapy Program
Milwaukee, Wisconsin, United States
Can-Med Medical Research, Inc.
Victoria, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Sunnybrook & Women's College HSC
Toronto, Ontario, Canada
Hospital Notre Dame du CHUM
Montreal, Quebec, Canada
Related Links
Results Point of Contact
- Title
- Director, Clinical Operations
- Organization
- Dendreon Corporation
Study Officials
- STUDY CHAIR
Paul Schellhammer, MD
Devine Tidewater Urology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2009
First Posted
February 23, 2009
Study Start
April 1, 2004
Primary Completion
January 1, 2009
Study Completion
April 1, 2009
Last Updated
November 29, 2023
Results First Posted
October 11, 2010
Record last verified: 2021-09