Study Stopped
Based on futility analysis showing \<30% chance of meeting primary endpoint.
GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer
A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve
2 other identifiers
interventional
626
8 countries
126
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started Jul 2004
126 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 16, 2004
CompletedFirst Posted
Study publicly available on registry
August 18, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedNovember 5, 2008
November 1, 2008
4.3 years
August 16, 2004
November 3, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival
0
Secondary Outcomes (1)
Bone pain and bone related events
0
Study Arms (2)
2
OTHERStandard of care - chemotherapy
1
EXPERIMENTALImmunotherapy
Interventions
Immunotherapy with allogeneic prostate vaccine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Prior treatment with chemotherapy
- Prior Immunotherapy
- Prior treatment with gene therapy
- Significant cancer related pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cell Genesyslead
Study Sites (126)
Central Alabama Oncology, LLC
Alabaster, Alabama, 35007, United States
Alaska Clinical Research Center
Anchorage, Alaska, 99508, United States
Palo Verde Hematology/Oncology
Glendale, Arizona, 85304, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
ACRC/Arizona Clinical Res. Ctr. Inc.
Tuscon, Arizona, 85715, United States
Arkansas Cancer Research Center
Little Rock, Arkansas, 72205, United States
Compassionate Cancer Care Medical Group, Inc.
Corona, California, 92882, United States
Pacific Coast Hem Onc. Medical Group
Fountain Valley, California, 92708, United States
California Cancer Care
Greenbrae, California, 94904, United States
Center for Urological Research
La Mesa, California, 91942, United States
Oncology Care Medical Associates
Montebello, California, 90640, United States
UC Irvine Medical Center
Orange, California, 92868, United States
San Bernardino Urological Associates
San Bernardino, California, 92404, United States
Sharp Healthcare
San Diego, California, 92123, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Cancer Research & Prevention Center
Soquel, California, 95073, United States
San Diego Cancer Center
Vista, California, 92081, United States
Univ. of Colorado Health Science Center
Aurora, Colorado, 80045, United States
Cancer Center of Colorado Springs
Colorado Springs, Colorado, 80907, United States
The Hope Clinic
Bristol, Connecticut, 06010, United States
Urology Center of Grove Hill
New Britain, Connecticut, 06052-1395, United States
Carl & Dorothy Bennett Cancer Center
Stamford, Connecticut, 06902, United States
Boca Raton Community Hospital, Inc.
Boca Raton, Florida, 33486, United States
Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Integrated Community Oncology Network
Jacksonville, Florida, 32256, United States
Oncology-Hematology Group of South Florida/Advanced Medical Specialists
Miami, Florida, 33176, United States
Cancer Centers of Florida
Ocoee, Florida, 34761, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Urology Consultants
Safety Harbor, Florida, 34695, United States
Atlanta VAMC
Atlanta, Georgia, 30033, United States
Georgia Cancer Specialists
Atlanta, Georgia, 30084, United States
Peachtree Hematology Oncology Consultants, PC
Atlanta, Georgia, 30309, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Central Georgia Cancer Care, P.C.
Macon, Georgia, 31201, United States
Straub Clinic & Hospital
Honolulu, Hawaii, 96813, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Welborn Clinic Research Center
Evansville, Indiana, 47713, United States
Fort Wayne Medical Oncology/Hematology Inc.
Fort Wayne, Indiana, 46815, United States
Louisiana Oncology Associates
Lafayette, Louisiana, 70506, United States
Johns Hopkins University
Baltimore, Maryland, 21231, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, 21701, United States
West Michigan Regional Cancer and Blood Center
Free Soil, Michigan, 49411, United States
William Beaumont Hospital, Cancer Clinical Trials Office
Royal Oak, Michigan, 48073-6706, United States
Newland Medical Associates, P.C.
Southfield, Michigan, 48075, United States
Hematology Oncology Consultants, Inc.
St Louis, Missouri, 63136, United States
Deaconess Billings Clinic
Billings, Montana, 59101, United States
Hematology/Oncology Centers of the Northern Rockies, P.C.
Billings, Montana, 59101, United States
Omaha VA Medical Center
Omaha, Nebraska, 68105, United States
Omaha VA Medical Center
Omaha, Nebraska, 68198-7680, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
The Center for Cancer & Hematologic Disease
Cherry Hill, New Jersey, 08003, United States
Hematology-Oncology Associates of Northern New Jersey
Morristown, New Jersey, 07962, United States
Summit Medical Group/Overlook Oncology Center
Summit, New Jersey, 07901, United States
Columbia University Medical Center
New York, New York, 10032, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Presbyterian Hospital/ Center for Cancer Research
Charlotte, North Carolina, 28204, United States
Northwestern Carolina Hematology Oncology, PA
Hickory, North Carolina, 28602, United States
Medcenter One Cancer Care / Odyssey Research
Bismarck, North Dakota, 58501, United States
Dakota Cancer Institute
Fargo, North Dakota, 58103, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Cleveland Clinic Foundation, Taussig Cancer Center
Cleveland, Ohio, 44195, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Urologic Surgery PC
Bala-Cynwyd, Pennsylvania, 19004, United States
Medical Oncology Associates
Kingston, Pennsylvania, 18704, United States
Lancaster Cancer Center, Ltd
Lancaster, Pennsylvania, 17601, United States
Urological Associates of Lancaster
Lancaster, Pennsylvania, 17604, United States
University of Pittsburgh Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Charleston Hematology Oncology
Charleston, South Carolina, 29403, United States
Memorial Health Care System
Chattanooga, Tennessee, 37404, United States
The West Clinic
Memphis, Tennessee, 38120, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75201, United States
Center for Oncology Research and Treatment PA
Dallas, Texas, 75230, United States
Urology Specialists and Associates, P.A.
Dallas, Texas, 75231, United States
Mobley Research Center
Houston, Texas, 77024, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Southwestern Oncology Research Department
Bennington, Vermont, 05201, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Mason Medical Center Urology
Seattle, Washington, 98101, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
ZNA Middelheim
Antwerp, B-2020, Belgium
Imelda Ziekenhuis
Bonheiden, 2820, Belgium
University Hospital Antwerp (UZA)
Edegem, 2650, Belgium
UZ Gent
Ghent, 9000, Belgium
Unversity Hospial Gent
Ghent, B-9000, Belgium
Virga Jesse Ziekenhuis
Hasselt, B-3500, Belgium
AZ Groeninge
Kortrijk, B-8500, Belgium
Heilig Hartziekenhuis Roeselare Men
Roeselare, B-8800, Belgium
Regionaal Ziekenhuis Sint Trudo
Sint-Truiden, B-3800, Belgium
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CHUM Notre-Dam
Montreal, Quebec, H2L 4M1, Canada
McGill University
Montreal, Quebec, H2W1S6, Canada
Ultra Med Inc.
Pointe-Claire, Quebec, H9R 4S3, Canada
Centre Hopitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Centre Paul Papin
Angers, 49033, France
Centre Francois Baclesse
Caen, 14076, France
Centre Georges Francois Leclerc
Dijon, 77980, France
Centre Leon Berard Service de Cancerologie Medicale
Lyon, 08, France
Institut Paoli-Calmettes
Marseille, 13009, France
Centre Rene Gauducheau
Nantes-Saint Herblain, 44805, France
Institut Jean Godinot
Reims, 51056, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
Universitatsklinikum Aachen Urologie
Aachen, 52074, Germany
der Technischen Universitat Dresden
Dresden, 1307, Germany
Universitatsklinik um Essen
Essen, 45122, Germany
Universitatsklinik um des Saarlande
Homburg/Saar, 66421, Germany
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
University Medical Centre Groningen
Groningen, Netherlands
University Hospital, Linkoping
Linköping, Sweden
University Hospital Lund
Lund, Sweden
Akademiska University Hospital
Uppsala, 85, Sweden
Addenbrooke's Hospital
Cambridge, CB2 2QQ, United Kingdom
Beatson Oncology Centre
Glasgow, G11 6NT, United Kingdom
St. James's University Hospital
Leeds, LS97TF, United Kingdom
Hammersmith Hospital
London, W12 0NN, United Kingdom
Mount Vernon Hospital
Middlesex, HA6 2RN, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, NE4 6BE, United Kingdom
Northampton General Hosptial
Northampton, NN1 5BD, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Oxford Cancer Centre, Churchill Hospital
Oxford, OX3 7LT, United Kingdom
Scunthorpe General Hospital
Scunthorpe, DN15 7BH, United Kingdom
Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
Glan Clwyd Hospital
Wales, LL18 5UJ, United Kingdom
Related Publications (1)
Vuky J, Corman JM, Porter C, Olgac S, Auerbach E, Dahl K. Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer. Oncologist. 2013 Jun;18(6):687-8. doi: 10.1634/theoncologist.2011-0234. Epub 2013 Jun 5.
PMID: 23740935DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 16, 2004
First Posted
August 18, 2004
Study Start
July 1, 2004
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
November 5, 2008
Record last verified: 2008-11