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

Sponsor
Bavarian Nordic (Industry)
Overall Status
Completed
CT.gov ID
NCT00078585
Collaborator
Therion Biologics Corporation (Industry), National Cancer Institute (NCI) (NIH)
120
Enrollment
47
Locations
62
Duration (Months)
2.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: PROSTVAC®-VF/TRICOM™
 Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
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
Study Start Date :
Nov 1, 2003
Actual Primary Completion Date :
Jan 4, 2006
Actual Study Completion Date :
Jan 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    • 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

    Locations

    Site City State Country Postal Code
    1 Urology Centers of Alabama Homewood Alabama United States 35209
    2 Alaska Clinical Research Center Anchorage Alaska United States 99508
    3 Urology Associates of Central California Fresno California United States 93720
    4 San Diego Urology Center La Mesa California United States 91942
    5 Loma Linda University Loma Linda California United States 92354
    6 Atlantic Urology Medical Group Long Beach California United States 90806
    7 Pacific Clinical Research Santa Monica California United States 90404
    8 Western Clinical Research, Inc. Torrance California United States 90505
    9 UCHSC Anschutz Cancer Pavilion Aurora Colorado United States 80010
    10 Connecticut Clinical Research Center Waterbury Connecticut United States 06708
    11 Georgetown University Medical Center Washington, D.C. District of Columbia United States 20007
    12 Washington Hospital Center Washington, D.C. District of Columbia United States 20010
    13 South Florida Medical Research Aventura Florida United States 33180
    14 Advanced Research Institute New Port Richey Florida United States 34652
    15 Midtown Urology Atlanta Georgia United States 30308
    16 North Idaho Urology Coeur d'Alene Idaho United States 83814
    17 Prairie Medical Associates, Ltd. Chicago Illinois United States 60616
    18 Medical and Surgical Specialists Galesburg Illinois United States 61401
    19 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    20 Carle Clinic Cancer Center Urbana Illinois United States 61801
    21 Metropolitan Urology Jeffersonville Indiana United States 47130
    22 Urologic Associates, PC Davenport Iowa United States 52807
    23 Franklin Square Hospital Center Baltimore Maryland United States 21237
    24 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    25 University of Nebraska Medical Center Omaha Nebraska United States 68198-7680
    26 Lawrenceville Urology Lawrenceville New Jersey United States 08648
    27 The Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    28 Urology Group of New Mexico Albuquerque New Mexico United States 87109
    29 The Urological Institute of Northeastern New York Albany New York United States 12208
    30 AccuMed Research Associates Garden City New York United States 11530
    31 Columbia Presbyterian Medical Center New York New York United States 10032
    32 Nyack Hospital Nyack New York United States 10960
    33 The Urology Center Greensboro North Carolina United States 27403
    34 University of Pittsburgh Pittsburgh Pennsylvania United States 15232
    35 Charleston Cancer Center Charleston South Carolina United States 29406
    36 Urology Associates Clinical Research Nashville Tennessee United States 37209
    37 Arlington Cancer Center Arlington Texas United States 76012
    38 Urology Clinic of North Texas, PA Dallas Texas United States 75231
    39 Texas Cancer Center Fort Worth Texas United States 76104
    40 Texas Cancer Care Weatherford Texas United States 76086
    41 Salt Lake Research Salt Lake City Utah United States 84124
    42 University of Vermont South Burlington Vermont United States 05403
    43 Virginia Urology Center Richmond Virginia United States 23235
    44 McGuire Research Institute Richmond Virginia United States 23249
    45 Midwest Research Specialists, LLC Milwaukee Wisconsin United States 53209
    46 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    47 Wyoming Research Foundation, Inc. Cheyenne Wyoming United States 82001

    Sponsors and Collaborators

    • Bavarian Nordic
    • Therion Biologics Corporation
    • National Cancer Institute (NCI)

    Investigators

    • Study Director: Thomas J Schuetz, MD, Therion Biologics Corporation
    • Principal Investigator: Philip W Kanthoff, MD, Dana-Faber Cancer Institut

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bavarian Nordic
    ClinicalTrials.gov Identifier:
    NCT00078585
    Other Study ID Numbers:
    • TBC-PRO-002
    • NCT00081120
    First Posted:
    Mar 3, 2004
    Last Update Posted:
    Sep 11, 2017
    Last Verified:
    Sep 1, 2017
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Sep 11, 2017