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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078585
• Other study ID #: TBC-PRO-002
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2004
• Last updated: September 7, 2017
• Start date: November 2003
• Est. completion date: January 2009

Study information

• Verified date: September 2017
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00081120

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2009
• Est. primary completion date: January 4, 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• PROSTVAC®-VF/TRICOM™

Locations

Country	Name	City	State
United States	The Urological Institute of Northeastern New York	Albany	New York
United States	Urology Group of New Mexico	Albuquerque	New Mexico
United States	Alaska Clinical Research Center	Anchorage	Alaska
United States	Arlington Cancer Center	Arlington	Texas
United States	Midtown Urology	Atlanta	Georgia
United States	UCHSC Anschutz Cancer Pavilion	Aurora	Colorado
United States	South Florida Medical Research	Aventura	Florida
United States	Franklin Square Hospital Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Charleston Cancer Center	Charleston	South Carolina
United States	Wyoming Research Foundation, Inc.	Cheyenne	Wyoming
United States	Prairie Medical Associates, Ltd.	Chicago	Illinois
United States	North Idaho Urology	Coeur d'Alene	Idaho
United States	Urology Clinic of North Texas, PA	Dallas	Texas
United States	Urologic Associates, PC	Davenport	Iowa
United States	Texas Cancer Center	Fort Worth	Texas
United States	Urology Associates of Central California	Fresno	California
United States	Medical and Surgical Specialists	Galesburg	Illinois
United States	AccuMed Research Associates	Garden City	New York
United States	The Urology Center	Greensboro	North Carolina
United States	Urology Centers of Alabama	Homewood	Alabama
United States	Metropolitan Urology	Jeffersonville	Indiana
United States	San Diego Urology Center	La Mesa	California
United States	Lawrenceville Urology	Lawrenceville	New Jersey
United States	Loma Linda University	Loma Linda	California
United States	Atlantic Urology Medical Group	Long Beach	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Midwest Research Specialists, LLC	Milwaukee	Wisconsin
United States	Urology Associates Clinical Research	Nashville	Tennessee
United States	The Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Advanced Research Institute	New Port Richey	Florida
United States	Columbia Presbyterian Medical Center	New York	New York
United States	Nyack Hospital	Nyack	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	McGuire Research Institute	Richmond	Virginia
United States	Virginia Urology Center	Richmond	Virginia
United States	Salt Lake Research	Salt Lake City	Utah
United States	Pacific Clinical Research	Santa Monica	California
United States	University of Vermont	South Burlington	Vermont
United States	Western Clinical Research, Inc.	Torrance	California
United States	Carle Clinic Cancer Center	Urbana	Illinois
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	Connecticut Clinical Research Center	Waterbury	Connecticut
United States	Texas Cancer Care	Weatherford	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Bavarian Nordic	National Cancer Institute (NCI), Therion Biologics Corporation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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/ — View Citation

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-targete — View Citation