Clinical trial NCT00078585: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
Collaborators: name: Therion Biologics Corporation
name: National Cancer Institute (NCI)
First posted: 2004-03-03
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center
state: Alaska
city: Fresno
country: United States
facility: Urology Associates of Central California
state: California
city: La Mesa
country: United States
facility: San Diego Urology Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Long Beach
country: United States
facility: Atlantic Urology Medical Group
state: California
city: Santa Monica
country: United States
facility: Pacific Clinical Research
state: California
city: Torrance
country: United States
facility: Western Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: UCHSC Anschutz Cancer Pavilion
state: Colorado
city: Waterbury
country: United States
facility: Connecticut Clinical Research Center
state: Connecticut
city: Washington, D.C.
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Washington, D.C.
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute
state: Florida
city: Atlanta
country: United States
facility: Midtown Urology
state: Georgia
city: Coeur d'Alene
country: United States
facility: North Idaho Urology
state: Idaho
city: Chicago
country: United States
facility: Prairie Medical Associates, Ltd.
state: Illinois
city: Galesburg
country: United States
facility: Medical and Surgical Specialists
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Clinic Cancer Center
state: Illinois
city: Jeffersonville
country: United States
facility: Metropolitan Urology
state: Indiana
city: Davenport
country: United States
facility: Urologic Associates, PC
state: Iowa
city: Baltimore
country: United States
facility: Franklin Square Hospital Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Lawrenceville
country: United States
facility: Lawrenceville Urology
state: New Jersey
city: New Brunswick
country: United States
facility: The Cancer Institute of New Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: Urology Group of New Mexico
state: New Mexico
city: Albany
country: United States
facility: The Urological Institute of Northeastern New York
state: New York
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Nyack
country: United States
facility: Nyack Hospital
state: New York
city: Greensboro
country: United States
facility: The Urology Center
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates Clinical Research
state: Tennessee
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Dallas
country: United States
facility: Urology Clinic of North Texas, PA
state: Texas
city: Fort Worth
country: United States
facility: Texas Cancer Center
state: Texas
city: Weatherford
country: United States
facility: Texas Cancer Care
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: South Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Richmond
country: United States
facility: Virginia Urology Center
state: Virginia
city: Richmond
country: United States
facility: McGuire Research Institute
state: Virginia
city: Milwaukee
country: United States
facility: Midwest Research Specialists, LLC
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Cheyenne
country: United States
facility: Wyoming Research Foundation, Inc.
state: Wyoming
Study officials:
affiliation: Therion Biologics Corporation
name: Thomas J Schuetz, MD
role: STUDY_DIRECTOR
affiliation: Dana-Faber Cancer Institut
name: Philip W Kanthoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.