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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT00849290
First received: February 19, 2009
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Metastatic Androgen Independent Prostate Cancer
Biological: APC8015F
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Dendreon:

Primary Outcome Measures:
  • Safety of APC8015F by Review of Reported Adverse Events [ Time Frame: periodically over 24 months ] [ Designated as safety issue: Yes ]
    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:
  • To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response [ Time Frame: periodically over 24 months ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: April 2004
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849290

  Hide Study Locations
Locations
United States, California
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
United States, Delaware
Helen F. Graham Cancer Center
Newark, Delaware, United States
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States
Walter Reid Army Medical Center
Washington, District of Columbia, United States
United States, Florida
Miami Cancer Center
Miami, Florida, United States
Hematology/Oncology Associates of the Treasure Coast
Port St. Lucie, Florida, United States
United States, Georgia
Georgia Urology, P.A.
Atlanta, Georgia, United States
United States, Illinois
Midwest Prostate & Urology Health Center
Chicago, Illinois, United States
Loyola University
Maywood, Illinois, United States
Lutheran General Cancer Center
Park Ridge, Illinois, United States
United States, Indiana
Indiana University
Indianapolis, Indiana, United States
United States, Maryland
Myron I Murdock MD LLC
Greenbelt, Maryland, United States
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Lahey Clinic (Department of Urology)
Burlington, Massachusetts, United States
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States
Associates in Urology, LLC
West Orange, New Jersey, United States
United States, New York
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
United States, North Carolina
McKay Urology
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
United States, Oregon
EACRI
Portland, Oregon, United States
Kaiser Permanente Medical Group
Portland, Oregon, United States
United States, Pennsylvania
Center for Urologic Care
Bryn Mawr, Pennsylvania, United States
Jefferson Medical College
Philadelphia, Pennsylvania, United States
United States, South Carolina
Grand Strand Urology
Myrtle Beach, South Carolina, United States
United States, Texas
Mary Crowley
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
United States, Utah
University of Utah
Salt Lake City, Utah, United States
United States, Virginia
Urology of Virginia, PC
Norfolk, Virginia, United States
United States, Washington
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
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States
University of Wisconsin, Madison
Madison, Wisconsin, United States
St. Luke's Hospital Immunotherapy Program
Milwaukee, Wisconsin, United States
Canada, British Columbia
Can-Med Medical Research, Inc.
Victoria, British Columbia, Canada
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Sunnybrook & Women's College HSC
Toronto, Ontario, Canada
Canada, Quebec
Hospital Notre Dame du CHUM
Montreal, Quebec, Canada
Sponsors and Collaborators
Dendreon
Investigators
Study Chair: Paul Schellhammer, MD Devine Tidewater Urology
  More Information

Additional Information:
No publications provided

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT00849290     History of Changes
Obsolete Identifiers: NCT00090922, NCT00170066, NCT00513006
Other Study ID Numbers: PB01
Study First Received: February 19, 2009
Results First Received: May 28, 2010
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014