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

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Biological: PROSTVAC®-VF/TRICOM™	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Metronidazole Metronidazole benzoate Metronidazole hydrochloride

U.S. FDA Resources

Further study details as provided by Therion Biologics Corporation:

Estimated Enrollment:	120
Study Start Date:	November 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078585

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Locations

United States, Alabama
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
United States, Alaska
Alaska Clinical Research Center
Anchorage, Alaska, United States, 99508
United States, California
Urology Associates of Central California
Fresno, California, United States, 93720
San Diego Urology Center
La Mesa, California, United States, 91942
Loma Linda University
Loma Linda, California, United States, 92354
Atlantic Urology Medical Group
Long Beach, California, United States, 90806
Pacific Clinical Research
Santa Monica, California, United States, 90404
Western Clinical Research, Inc.
Torrance, California, United States, 90505
United States, Colorado
UCHSC Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80010
United States, Connecticut
Connecticut Clinical Research Center
Waterbury, Connecticut, United States, 06708
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Advanced Research Institute
New Port Richey, Florida, United States, 34652
United States, Georgia
Midtown Urology
Atlanta, Georgia, United States, 30308
United States, Idaho
North Idaho Urology
Coeur D Alene, Idaho, United States, 83814
United States, Illinois
Prairie Medical Associates, Ltd.
Chicago, Illinois, United States, 60616
Medical and Surgical Specialists
Galesburg, Illinois, United States, 61401
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Carle Clinic Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Metropolitan Urology
Jeffersonville, Indiana, United States, 47130
United States, Iowa
Urologic Associates, PC
Davenport, Iowa, United States, 52807
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, New Jersey
Lawrenceville Urology
Lawrenceville, New Jersey, United States, 08648
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
Urology Group of New Mexico
Albuquerque, New Mexico, United States, 87109
United States, New York
The Urological Institute of Northeastern New York
Albany, New York, United States, 12208
AccuMed Research Associates
Garden City, New York, United States, 11530
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
Nyack Hospital
Nyack, New York, United States, 10960
United States, North Carolina
The Urology Center
Greensboro, North Carolina, United States, 27403
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
United States, Tennessee
Urology Associates Clinical Research
Nashville, Tennessee, United States, 37209
United States, Texas
Arlington Cancer Center
Arlington, Texas, United States, 76012
Urology Clinic of North Texas, PA
Dallas, Texas, United States, 75231
Texas Cancer Center
Fort Worth, Texas, United States, 76104
Texas Cancer Care
Weatherford, Texas, United States, 76086
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84124
United States, Vermont
University of Vermont
South Burlington, Vermont, United States, 05403
United States, Virginia
McGuire Research Institute
Richmond, Virginia, United States, 23249
Virginia Urology Center
Richmond, Virginia, United States, 23235
United States, Wisconsin
Midwest Research Specialists, LLC
Milwaukee, Wisconsin, United States, 53209
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
United States, Wyoming
Wyoming Research Foundation, Inc.
Cheyenne, Wyoming, United States, 82001

Sponsors and Collaborators

Therion Biologics Corporation

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00078585 History of Changes
Obsolete Identifiers:	NCT00081120
Other Study ID Numbers:	TBC-PRO-002
Study First Received:	March 1, 2004
Last Updated:	July 7, 2005
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Metronidazole

Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 19, 2013