PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

Condition(s) targeted: Prostate Cancer

Intervention: PROSTVAC®-VF/TRICOM™ (Biological)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Therion Biologics Corporation

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.

Official title: A Phase II Randomized, Double Blind, Controlled Study to Evaluate the Safety and Efficacy of PROSTVAC®-VF/TRICOM™ in Combination With GM-CSF in Patients With Androgen-Independent Adenocarcinoma of the Prostate

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

- Male patients > 18 years of age who have been vaccinated against smallpox;

- Histological confirmation of adenocarcinoma of the prostate with evidence of

metastatic disease including either of the following: Lymph node metastasis measurable by CT and/or Bone metastasis evaluable by bone scan;

- Despite hormone therapy, there is evidence of two consecutive increases in PSA

(Prostate Specific Antigen);

- Gleason Score of 7 or lower at initial diagnosis.

Please note that there are additional eligibility criteria that you must meet to qualify.

If you do qualify to participate, study personnel will explain the trial in detail and answer any questions you may have. You can then decide whether or not you wish to participate. If you do not qualify for the trial, study personnel will explain the reasons.

Urology Centers of Alabama, Homewood, Alabama 35209, United States

Alaska Clinical Research Center, Anchorage, Alaska 99508, United States

Western Clinical Research, Inc., Torrance, California 90505, United States

Urology Associates of Central California, Fresno, California 93720, United States

Pacific Clinical Research, Santa Monica, California 90404, United States

Loma Linda University, Loma Linda, California 92354, United States

San Diego Urology Center, La Mesa, California 91942, United States

Atlantic Urology Medical Group, Long Beach, California 90806, United States

UCHSC Anschutz Cancer Pavilion, Aurora, Colorado 80010, United States

Connecticut Clinical Research Center, Waterbury, Connecticut 06708, United States

Georgetown University Medical Center, Washington, District of Columbia 20007, United States

Washington Hospital Center, Washington, District of Columbia 20010, United States

South Florida Medical Research, Aventura, Florida 33180, United States

Advanced Research Institute, New Port Richey, Florida 34652, United States

Midtown Urology, Atlanta, Georgia 30308, United States

North Idaho Urology, Coeur D Alene, Idaho 83814, United States

OSF Saint Francis Medical Center, Peoria, Illinois 61637, United States

Medical and Surgical Specialists, Galesburg, Illinois 61401, United States

Carle Clinic Cancer Center, Urbana, Illinois 61801, United States

Prairie Medical Associates, Ltd., Chicago, Illinois 60616, United States

Metropolitan Urology, Jeffersonville, Indiana 47130, United States

Urologic Associates, PC, Davenport, Iowa 52807, United States

Franklin Square Hospital Center, Baltimore, Maryland 21237, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-7680, United States

Lawrenceville Urology, Lawrenceville, New Jersey 08648, United States

The Cancer Institute of New Jersey, New Brunswick, New Jersey 08903, United States

Urology Group of New Mexico, Albuquerque, New Mexico 87109, United States

Nyack Hospital, Nyack, New York 10960, United States

AccuMed Research Associates, Garden City, New York 11530, United States

The Urological Institute of Northeastern New York, Albany, New York 12208, United States

Columbia Presbyterian Medical Center, New York, New York 10032, United States

The Urology Center, Greensboro, North Carolina 27403, United States

University of Pittsburgh, Pittsburgh, Pennsylvania 15232, United States

Charleston Cancer Center, Charleston, South Carolina 29406, United States

Urology Associates Clinical Research, Nashville, Tennessee 37209, United States

Urology Clinic of North Texas, PA, Dallas, Texas 75231, United States

Arlington Cancer Center, Arlington, Texas 76012, United States

Texas Cancer Center, Fort Worth, Texas 76104, United States

Texas Cancer Care, Weatherford, Texas 76086, United States

Salt Lake Research, Salt Lake City, Utah 84124, United States

University of Vermont, South Burlington, Vermont 05403, United States

McGuire Research Institute, Richmond, Virginia 23249, United States

Virginia Urology Center, Richmond, Virginia 23235, United States

Midwest Research Specialists, LLC, Milwaukee, Wisconsin 53209, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Wyoming Research Foundation, Inc., Cheyenne, Wyoming 82001, United States

Starting date: November 2003
Last updated: July 7, 2005