Back to resultsPROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PROSTVAC®-VF/TRICOM™
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility 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.
Sites / Locations
- Urology Centers of Alabama
- Alaska Clinical Research Center
- Urology Associates of Central California
- San Diego Urology Center
- Loma Linda University
- Atlantic Urology Medical Group
- Pacific Clinical Research
- Western Clinical Research, Inc.
- UCHSC Anschutz Cancer Pavilion
- Connecticut Clinical Research Center
- Georgetown University Medical Center
- Washington Hospital Center
- South Florida Medical Research
- Advanced Research Institute
- Midtown Urology
- North Idaho Urology
- Prairie Medical Associates, Ltd.
- Medical and Surgical Specialists
- OSF Saint Francis Medical Center
- Carle Clinic Cancer Center
- Metropolitan Urology
- Urologic Associates, PC
- Franklin Square Hospital Center
- Beth Israel Deaconess Medical Center
- University of Nebraska Medical Center
- Lawrenceville Urology
- The Cancer Institute of New Jersey
- Urology Group of New Mexico
- The Urological Institute of Northeastern New York
- AccuMed Research Associates
- Columbia Presbyterian Medical Center
- Nyack Hospital
- The Urology Center
- University of Pittsburgh
- Charleston Cancer Center
- Urology Associates Clinical Research
- Arlington Cancer Center
- Urology Clinic of North Texas, PA
- Texas Cancer Center
- Texas Cancer Care
- Salt Lake Research
- University of Vermont
- Virginia Urology Center
- McGuire Research Institute
- Midwest Research Specialists, LLC
- Medical College of Wisconsin
- Wyoming Research Foundation, Inc.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00078585
First Posted
March 1, 2004
Last Updated
September 7, 2017
Sponsor
Bavarian Nordic
Collaborators
Therion Biologics Corporation, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00078585
Brief Title
PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
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 Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
January 4, 2006 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bavarian Nordic
Collaborators
Therion Biologics Corporation, National Cancer Institute (NCI)
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
PROSTVAC®-VF/TRICOM™
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Schuetz, MD
Organizational Affiliation
Therion Biologics Corporation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Philip W Kanthoff, MD
Organizational Affiliation
Dana-Faber Cancer Institut
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology Centers of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Alaska Clinical Research Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Urology Associates of Central California
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
San Diego Urology Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Atlantic Urology Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pacific Clinical Research
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Western Clinical Research, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
UCHSC Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Connecticut Clinical Research Center
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Washington Hospital Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Advanced Research Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Midtown Urology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
North Idaho Urology
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Prairie Medical Associates, Ltd.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Medical and Surgical Specialists
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Carle Clinic Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Metropolitan Urology
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Urologic Associates, PC
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
Franklin Square Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Lawrenceville Urology
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
The Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Urology Group of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
The Urological Institute of Northeastern New York
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Nyack Hospital
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Facility Name
The Urology Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Charleston Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Urology Associates Clinical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Urology Clinic of North Texas, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Texas Cancer Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Cancer Care
City
Weatherford
State/Province
Texas
ZIP/Postal Code
76086
Country
United States
Facility Name
Salt Lake Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
University of Vermont
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Virginia Urology Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
McGuire Research Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Midwest Research Specialists, LLC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Wyoming Research Foundation, Inc.
City
Cheyenne
State/Province
Wyoming
ZIP/Postal Code
82001
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20100959
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-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.
Results Reference
result
PubMed Identifier
27646950
Citation
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.
Results Reference
result
Learn more about this trial
PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
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