PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
- Conditions
- Prostate Cancer
- Registration Number
- NCT00078585
- Lead Sponsor
- Bavarian Nordic
- Brief Summary
PROSTVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the immune system can be taught to fight cancer by directing the immune system to attack specific targets found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This trial will help determine if this vaccine can help fight cancer.
This multi-center, double-blind, randomized, empty vector-controlled trial is designed to evaluate the safety and efficacy of PROSTVAC-VF/TRICOM co-administered with GM-CSF versus the empty viral vector co-administered with placebo in the treatment of patients with androgen-independent prostate cancer (AIPC).
All patients will be required to sign an informed consent prior to the performance of any on-study procedures. Patients will be screened for eligibility within 14 days prior to vaccine administration. Patients who meet all inclusion and exclusion criteria will be centrally randomized into the study and will receive a unique patient identification number and a blinded treatment assignment. The ratio of active treatment to empty vector control (placebo) is 2:1.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
San Diego Urology Center
🇺🇸La Mesa, California, United States
Urology Associates of Central California
🇺🇸Fresno, California, United States
Western Clinical Research, Inc.
🇺🇸Torrance, California, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Georgetown University Medical Center
🇺🇸Washington, D.C., District of Columbia, United States
Washington Hospital Center
🇺🇸Washington, D.C., District of Columbia, United States
North Idaho Urology
🇺🇸Coeur d'Alene, Idaho, United States
Loma Linda University
🇺🇸Loma Linda, California, United States
Alaska Clinical Research Center
🇺🇸Anchorage, Alaska, United States
The Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
OSF Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Advanced Research Institute
🇺🇸New Port Richey, Florida, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Urology Group of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Pacific Clinical Research
🇺🇸Santa Monica, California, United States
Arlington Cancer Center
🇺🇸Arlington, Texas, United States
Prairie Medical Associates, Ltd.
🇺🇸Chicago, Illinois, United States
Midtown Urology
🇺🇸Atlanta, Georgia, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Atlantic Urology Medical Group
🇺🇸Long Beach, California, United States
Connecticut Clinical Research Center
🇺🇸Waterbury, Connecticut, United States
Urologic Associates, PC
🇺🇸Davenport, Iowa, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
The Urological Institute of Northeastern New York
🇺🇸Albany, New York, United States
Columbia Presbyterian Medical Center
🇺🇸New York, New York, United States
The Urology Center
🇺🇸Greensboro, North Carolina, United States
Urology Clinic of North Texas, PA
🇺🇸Dallas, Texas, United States
Texas Cancer Center
🇺🇸Fort Worth, Texas, United States
Wyoming Research Foundation, Inc.
🇺🇸Cheyenne, Wyoming, United States
Urology Associates Clinical Research
🇺🇸Nashville, Tennessee, United States
UCHSC Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Midwest Research Specialists, LLC
🇺🇸Milwaukee, Wisconsin, United States
University of Vermont
🇺🇸South Burlington, Vermont, United States
Lawrenceville Urology
🇺🇸Lawrenceville, New Jersey, United States
AccuMed Research Associates
🇺🇸Garden City, New York, United States
Medical and Surgical Specialists
🇺🇸Galesburg, Illinois, United States
Metropolitan Urology
🇺🇸Jeffersonville, Indiana, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Texas Cancer Care
🇺🇸Weatherford, Texas, United States
Carle Clinic Cancer Center
🇺🇸Urbana, Illinois, United States
Nyack Hospital
🇺🇸Nyack, New York, United States
Charleston Cancer Center
🇺🇸Charleston, South Carolina, United States
Virginia Urology Center
🇺🇸Richmond, Virginia, United States
McGuire Research Institute
🇺🇸Richmond, Virginia, United States