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

September 7, 2017 updated by: Bavarian Nordic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bavarian Nordic

Collaborators

National Cancer Institute (NCI)
Therion Biologics Corporation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

January 4, 2006

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 1, 2004

First Submitted That Met QC Criteria

March 2, 2004

First Posted (Estimate)

March 3, 2004

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBC-PRO-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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