PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
NCT ID: NCT00078585
Last Updated: 2017-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2003-11-30
2009-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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PROSTVAC®-VF/TRICOM™
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
MALE
No
Sponsors
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Therion Biologics Corporation
INDUSTRY
National Cancer Institute (NCI)
NIH
Bavarian Nordic
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas J Schuetz, MD
Role: STUDY_DIRECTOR
Therion Biologics Corporation
Philip W Kanthoff, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Faber Cancer Institut
Locations
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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
Lawrenceville Urology
Lawrenceville, New Jersey, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Urology Group of New Mexico
Albuquerque, New Mexico, United States
The Urological Institute of Northeastern New York
Albany, New York, United States
AccuMed Research Associates
Garden City, New York, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Nyack Hospital
Nyack, New York, United States
The Urology Center
Greensboro, North Carolina, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Charleston Cancer Center
Charleston, South Carolina, United States
Urology Associates Clinical Research
Nashville, Tennessee, United States
Arlington Cancer Center
Arlington, Texas, United States
Urology Clinic of North Texas, PA
Dallas, Texas, United States
Texas Cancer Center
Fort Worth, Texas, United States
Texas Cancer Care
Weatherford, Texas, United States
Salt Lake Research
Salt Lake City, Utah, United States
University of Vermont
South Burlington, Vermont, United States
Virginia Urology Center
Richmond, Virginia, United States
McGuire Research Institute
Richmond, Virginia, United States
Midwest Research Specialists, LLC
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Wyoming Research Foundation, Inc.
Cheyenne, Wyoming, United States
Countries
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References
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Kantoff PW, Gulley JL, Pico-Navarro C. Revised Overall Survival Analysis of a Phase II, Randomized, Double-Blind, Controlled Study of PROSTVAC in Men With Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2017 Jan;35(1):124-125. doi: 10.1200/JCO.2016.69.7748. Epub 2016 Sep 30. No abstract available.
Kantoff PW, Schuetz TJ, Blumenstein BA, Glode LM, Bilhartz DL, Wyand M, Manson K, Panicali DL, Laus R, Schlom J, Dahut WL, Arlen PM, Gulley JL, Godfrey WR. Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer. J Clin Oncol. 2010 Mar 1;28(7):1099-105. doi: 10.1200/JCO.2009.25.0597. Epub 2010 Jan 25.
Other Identifiers
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TBC-PRO-002
Identifier Type: -
Identifier Source: org_study_id
NCT00081120
Identifier Type: -
Identifier Source: nct_alias
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