GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Drug: Chemotherapy (Taxotere and prednisone)Biological: Immunotherapy with allogeneic prostate vaccine
- Registration Number
- NCT00089856
- Lead Sponsor
- Cell Genesys
- Brief Summary
The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 626
- Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
- Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
- Detectable metastases
- Any Gleason score
- ECOG performance status 0-2
- Prior treatment with chemotherapy
- Prior Immunotherapy
- Prior treatment with gene therapy
- Significant cancer related pain
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Chemotherapy (Taxotere and prednisone) Standard of care - chemotherapy 1 Immunotherapy with allogeneic prostate vaccine Immunotherapy
- Primary Outcome Measures
Name Time Method Survival 0
- Secondary Outcome Measures
Name Time Method Bone pain and bone related events 0
Trial Locations
- Locations (125)
The Hope Clinic
🇺🇸Bristol, Connecticut, United States
Arkansas Cancer Research Center
🇺🇸Little Rock, Arkansas, United States
ACRC/Arizona Clinical Res. Ctr. Inc.
🇺🇸Tuscon, Arizona, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
🇺🇸Frederick, Maryland, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
Charleston Hematology Oncology
🇺🇸Charleston, South Carolina, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
The Center for Cancer & Hematologic Disease
🇺🇸Cherry Hill, New Jersey, United States
Hematology-Oncology Associates of Northern New Jersey
🇺🇸Morristown, New Jersey, United States
University Hospital Antwerp (UZA)
🇧🇪Edegem, Belgium
The West Clinic
🇺🇸Memphis, Tennessee, United States
UZ Gent
🇧🇪Gent, Belgium
Unversity Hospial Gent
🇧🇪Gent, Belgium
Virga Jesse Ziekenhuis
🇧🇪Hasselt, Belgium
CHUM Notre-Dam
🇨🇦Montreal, Quebec, Canada
McGill University
🇨🇦Montreal, Quebec, Canada
AZ Groeninge
🇧🇪Kortrijk, Belgium
Heilig Hartziekenhuis Roeselare Men
🇧🇪Roeselare, Belgium
Regionaal Ziekenhuis Sint Trudo
🇧🇪Sint-Truiden, Belgium
Memorial Health Care System
🇺🇸Chattanooga, Tennessee, United States
Atlanta VAMC
🇺🇸Atlanta, Georgia, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
University of Pittsburgh Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Carl & Dorothy Bennett Cancer Center
🇺🇸Stamford, Connecticut, United States
Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Hematology Oncology Consultants, Inc.
🇺🇸St. Louis, Missouri, United States
Mary Crowley Medical Research Center
🇺🇸Dallas, Texas, United States
Centre Hopitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Ultra Med Inc.
🇨🇦Pointe-Claire, Quebec, Canada
Mobley Research Center
🇺🇸Houston, Texas, United States
Dakota Cancer Institute
🇺🇸Fargo, North Dakota, United States
Cancer Centers of Florida
🇺🇸Ocoee, Florida, United States
Alaska Clinical Research Center
🇺🇸Anchorage, Alaska, United States
Central Alabama Oncology, LLC
🇺🇸Alabaster, Alabama, United States
Center for Urological Research
🇺🇸La Mesa, California, United States
Cancer Research & Prevention Center
🇺🇸Soquel, California, United States
Presbyterian Hospital/ Center for Cancer Research
🇺🇸Charlotte, North Carolina, United States
Pacific Coast Hem Onc. Medical Group
🇺🇸Fountain Valley, California, United States
Newland Medical Associates, P.C.
🇺🇸Southfield, Michigan, United States
Medcenter One Cancer Care / Odyssey Research
🇺🇸Bismarck, North Dakota, United States
Palo Verde Hematology/Oncology
🇺🇸Glendale, Arizona, United States
William Beaumont Hospital, Cancer Clinical Trials Office
🇺🇸Royal Oak, Michigan, United States
ZNA Middelheim
🇧🇪Antwerp, Belgium
Institut Jean Godinot
🇫🇷Reims Cedex, France
Hematology Oncology Associates of the Treasure Coast
🇺🇸Port St. Lucie, Florida, United States
Welborn Clinic Research Center
🇺🇸Evansville, Indiana, United States
Straub Clinic & Hospital
🇺🇸Honolulu, Hawaii, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Center for Oncology Research and Treatment PA
🇺🇸Dallas, Texas, United States
Centre Rene Gauducheau
🇫🇷Nantes-Saint Herblain, France
Universitatsklinik um des Saarlande
🇩🇪Homburg/Saar, Germany
West Michigan Regional Cancer and Blood Center
🇺🇸Free Soil, Michigan, United States
der Technischen Universitat Dresden
🇩🇪Dresden, Germany
Deaconess Billings Clinic
🇺🇸Billings, Montana, United States
Lancaster Cancer Center, Ltd
🇺🇸Lancaster, Pennsylvania, United States
Imelda Ziekenhuis
🇧🇪Bonheiden, Belgium
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Centre Leon Berard Service de Cancerologie Medicale
🇫🇷Lyon Cedex, France
Cleveland Clinic Foundation, Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Northwestern Carolina Hematology Oncology, PA
🇺🇸Hickory, North Carolina, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Urologic Surgery PC
🇺🇸Bala Cynwyd, Pennsylvania, United States
Central Georgia Cancer Care, P.C.
🇺🇸Macon, Georgia, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Louisiana Oncology Associates
🇺🇸Lafayette, Louisiana, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Centre Francois Baclesse
🇫🇷Caen Cedex 5, France
Beatson Oncology Centre
🇬🇧Glasgow, United Kingdom
Urological Associates of Lancaster
🇺🇸Lancaster, Pennsylvania, United States
Southwestern Oncology Research Department
🇺🇸Bennington, Vermont, United States
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Centre Alexis Vautrin
🇫🇷Vandoeuvre les Nancy Cedex, France
Mount Vernon Hospital
🇬🇧Middlesex, United Kingdom
Hammersmith Hospital
🇬🇧London, United Kingdom
Universitatsklinikum Aachen Urologie
🇩🇪Aachen, Germany
St. James's University Hospital
🇬🇧Leeds, United Kingdom
Northampton General Hosptial
🇬🇧Northampton, United Kingdom
California Pacific Medical Center
🇺🇸San Francisco, California, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Urology San Antonio
🇺🇸San Antonio, Texas, United States
University Hospital Lund
🇸🇪Lund, Sweden
Akademiska University Hospital
🇸🇪Uppsala, Sweden
Glan Clwyd Hospital
🇬🇧Wales, United Kingdom
Centre Paul Papin
🇫🇷Angers Cedex, France
Centre Georges Francois Leclerc
🇫🇷Dijon Cedex, France
Institut Paoli-Calmettes
🇫🇷Marseille, France
Univ. of Colorado Health Science Center
🇺🇸Aurora, Colorado, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Omaha VA Medical Center
🇺🇸Omaha, Nebraska, United States
Universitatsklinik um Essen
🇩🇪Essen, Germany
California Cancer Care
🇺🇸Greenbrae, California, United States
Boca Raton Community Hospital, Inc.
🇺🇸Boca Raton, Florida, United States
Georgia Cancer Specialists
🇺🇸Atlanta, Georgia, United States
Oncology-Hematology Group of South Florida/Advanced Medical Specialists
🇺🇸Miami, Florida, United States
Urology Consultants
🇺🇸Safety Harbor, Florida, United States
Fort Wayne Medical Oncology/Hematology Inc.
🇺🇸Fort Wayne, Indiana, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
The Don and Sybil Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Virginia Mason Medical Center Urology
🇺🇸Seattle, Washington, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Peachtree Hematology Oncology Consultants, PC
🇺🇸Atlanta, Georgia, United States
Oncology Care Medical Associates
🇺🇸Montebello, California, United States
Cancer Center of Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
San Bernardino Urological Associates
🇺🇸San Bernardino, California, United States
Urology Center of Grove Hill
🇺🇸New Britain, Connecticut, United States
UC Irvine Medical Center
🇺🇸Orange, California, United States
Integrated Community Oncology Network
🇺🇸Jacksonville, Florida, United States
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Hematology/Oncology Centers of the Northern Rockies, P.C.
🇺🇸Billings, Montana, United States
Medical Oncology Associates
🇺🇸Kingston, Pennsylvania, United States
Summit Medical Group/Overlook Oncology Center
🇺🇸Summit, New Jersey, United States
Urology Specialists and Associates, P.A.
🇺🇸Dallas, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
University Medical Centre Groningen
🇳🇱Groningen, Netherlands
University Hospital, Linkoping
🇸🇪Linkoping, Sweden
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Scunthorpe General Hospital
🇬🇧Scunthorpe, United Kingdom
Newcastle General Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Oxford Cancer Centre, Churchill Hospital
🇬🇧Oxford, United Kingdom
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Compassionate Cancer Care Medical Group, Inc.
🇺🇸Corona, California, United States
San Diego Cancer Center
🇺🇸Vista, California, United States
Sharp Healthcare
🇺🇸San Diego, California, United States