PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00078585
- Run by
- Bavarian Nordic
- People needed
- 120
- Starts
- 2003-11-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2017-09-11
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Urology Centers of Alabama — Homewood, Alabama, United States
- Alaska Clinical Research Center — Anchorage, Alaska, United States
- Urology Associates of Central California — Fresno, California, United States
- San Diego Urology Center — La Mesa, California, United States
- Loma Linda University — Loma Linda, California, United States
- Atlantic Urology Medical Group — Long Beach, California, United States
- Pacific Clinical Research — Santa Monica, California, United States
- Western Clinical Research, Inc. — Torrance, California, United States
- UCHSC Anschutz Cancer Pavilion — Aurora, Colorado, United States
- Connecticut Clinical Research Center — Waterbury, Connecticut, 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
- South Florida Medical Research — Aventura, Florida, United States
- Advanced Research Institute — New Port Richey, Florida, United States
- Midtown Urology — Atlanta, Georgia, United States
- North Idaho Urology — Coeur d'Alene, Idaho, United States
- Prairie Medical Associates, Ltd. — Chicago, Illinois, United States
- Medical and Surgical Specialists — Galesburg, Illinois, United States
- OSF Saint Francis Medical Center — Peoria, Illinois, United States
- Carle Clinic Cancer Center — Urbana, Illinois, United States
- Metropolitan Urology — Jeffersonville, Indiana, United States
- Urologic Associates, PC — Davenport, Iowa, United States
- Franklin Square Hospital Center — Baltimore, Maryland, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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