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GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

Information source: Cell Genesys
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Immunotherapy with allogeneic prostate vaccine (Biological); Chemotherapy (Taxotere and prednisone) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Cell Genesys

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.

As this is a survival trial and it is difficult to predict when deaths or the primary/secondary endpoints will occur, the anticipated completion dates provided represent the actual completion of accrual, and the timeframes for the primary/secondary endpoints cannot be accurately estimated.

Clinical Details

Official title: 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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Survival

Secondary outcome: Bone pain and bone related events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- Prior treatment with chemotherapy

- Prior Immunotherapy

- Prior treatment with gene therapy

- Significant cancer related pain

Locations and Contacts

Virga Jesse Ziekenhuis, Hasselt B-3500, Belgium

AZ Groeninge, Kortrijk B-8500, Belgium

ZNA Middelheim, Antwerp B-2020, Belgium

Regionaal Ziekenhuis Sint Trudo, Sint-Truiden B-3800, Belgium

Heilig Hartziekenhuis Roeselare Men, Roeselare B-8800, Belgium

University Hospital Antwerp (UZA), Edegem 2650, Belgium

Imelda Ziekenhuis, Bonheiden 2820, Belgium

UZ Gent, Gent 9000, Belgium

Unversity Hospial Gent, Gent B-9000, Belgium

Centre Alexis Vautrin, Vandoeuvre les Nancy Cedex 54511, France

Centre Georges Francois Leclerc, Dijon Cedex 77980, France

Institut Jean Godinot, Reims Cedex 51056, France

Centre Paul Papin, Angers Cedex 49033, France

Centre Francois Baclesse, Caen Cedex 5 14076, France

Centre Rene Gauducheau, Nantes-Saint Herblain 44805, France

Institut Paoli-Calmettes, Marseille 13009, France

Centre Leon Berard Service de Cancerologie Medicale, Lyon Cedex 08, France

Universitatsklinik um Essen, Essen 45122, Germany

der Technischen Universitat Dresden, Dresden 1307, Germany

Universitatsklinik um des Saarlande, Homburg/Saar 66421, Germany

Universitatsklinikum Aachen Urologie, Aachen 52074, Germany

University Medical Centre Groningen, Groningen, Netherlands

VU Medisch Centrum, Amsterdam 1081 HV, Netherlands

Akademiska University Hospital, Uppsala 85, Sweden

University Hospital Lund, Lund, Sweden

University Hospital, Linkoping, Linkoping, Sweden

Beatson Oncology Centre, Glasgow G11 6NT, United Kingdom

St. James's University Hospital, Leeds LS97TF, United Kingdom

Newcastle General Hospital, Newcastle upon Tyne NE4 6BE, United Kingdom

Royal Hallamshire Hospital, Sheffield S10 2JF, United Kingdom

Nottingham City Hospital, Nottingham NG5 1PB, United Kingdom

Hammersmith Hospital, London W12 0NN, United Kingdom

Oxford Cancer Centre, Churchill Hospital, Oxford OX3 7LT, United Kingdom

Addenbrooke's Hospital, Cambridge CB2 2QQ, United Kingdom

Mount Vernon Hospital, Middlesex HA6 2RN, United Kingdom

Glan Clwyd Hospital, Wales LL18 5UJ, United Kingdom

Northampton General Hosptial, Northampton NN1 5BD, United Kingdom

Scunthorpe General Hospital, Scunthorpe DN15 7BH, United Kingdom

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

Sharp Healthcare, San Diego, California 92123, 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

Cancer Research & Prevention Center, Soquel, California 95073, United States

California Cancer Care, Greenbrae, California 94904, United States

Oncology Care Medical Associates, Montebello, California 90640, United States

San Diego Cancer Center, Vista, California 92081, United States

Center for Urological Research, La Mesa, California 91942, United States

California Pacific Medical Center, San Francisco, California 94115, United States

UC Irvine Medical Center, Orange, California 92868, United States

San Bernardino Urological Associates, San Bernardino, California 92404, United States

Cancer Center of Colorado Springs, Colorado Springs, Colorado 80907, United States

Univ. of Colorado Health Science Center, Aurora, Colorado 80045, United States

Urology Center of Grove Hill, New Britain, Connecticut 06052-1395, United States

Carl & Dorothy Bennett Cancer Center, Stamford, Connecticut 06902, United States

The Hope Clinic, Bristol, Connecticut 06010, United States

Cancer Centers of Florida, Ocoee, Florida 34761, United States

Hematology Oncology Associates of the Treasure Coast, Port St. Lucie, Florida 34952, United States

Urology Consultants, Safety Harbor, Florida 34695, United States

Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital, Fort Lauderdale, Florida 33308, United States

Boca Raton Community Hospital, Inc., Boca Raton, Florida 33486, 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

Central Georgia Cancer Care, P.C., Macon, Georgia 31201, United States

Georgia Cancer Specialists, Atlanta, Georgia 30084, United States

Winship Cancer Institute, Emory University, Atlanta, Georgia 30322, United States

Peachtree Hematology Oncology Consultants, PC, Atlanta, Georgia 30309, United States

Atlanta VAMC, Atlanta, Georgia 30033, 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

Frederick Memorial Hospital Regional Cancer Therapy Center, Frederick, Maryland 21701, United States

Johns Hopkins University, Baltimore, Maryland 21231, United States

William Beaumont Hospital, Cancer Clinical Trials Office, Royal Oak, Michigan 48073-6706, United States

West Michigan Regional Cancer and Blood Center, Free Soil, Michigan 49411, United States

Newland Medical Associates, P.C., Southfield, Michigan 48075, United States

Hematology Oncology Consultants, Inc., St. Louis, Missouri 63136, United States

Hematology/Oncology Centers of the Northern Rockies, P.C., Billings, Montana 59101, United States

Deaconess Billings Clinic, Billings, Montana 59101, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-7680, United States

Omaha VA Medical Center, Omaha, Nebraska 68105, United States

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, 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

The Center for Cancer & Hematologic Disease, Cherry Hill, New Jersey 08003, United States

SUNY Upstate Medical University, Syracuse, New York 13210, United States

Jacobi Medical Center, Bronx, New York 10461, United States

Columbia University Medical Center, New York, New York 10032, United States

Northwestern Carolina Hematology Oncology, PA, Hickory, North Carolina 28602, United States

Presbyterian Hospital/ Center for Cancer Research, Charlotte, North Carolina 28204, 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

Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada

Providence Portland Medical Center, Portland, Oregon 97213, United States

Medical Oncology Associates, Kingston, Pennsylvania 18704, United States

Urological Associates of Lancaster, Lancaster, Pennsylvania 17604, United States

University of Pittsburgh Cancer Center, Pittsburgh, Pennsylvania 15232, United States

Lancaster Cancer Center, Ltd, Lancaster, Pennsylvania 17601, United States

Urologic Surgery PC, Bala Cynwyd, Pennsylvania 19004, United States

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

Charleston Hematology Oncology, Charleston, South Carolina 29403, United States

The West Clinic, Memphis, Tennessee 38120, United States

Memorial Health Care System, Chattanooga, Tennessee 37404, United States

Mary Crowley Medical Research Center, Dallas, Texas 75201, United States

Tyler Cancer Center, Tyler, Texas 75702, United States

Urology Specialists and Associates, P.A., Dallas, Texas 75231, United States

Center for Oncology Research and Treatment PA, Dallas, Texas 75230, United States

Urology San Antonio, San Antonio, Texas 78229, United States

The Don and Sybil Harrington Cancer Center, Amarillo, Texas 79106, United States

Mobley Research Center, Houston, Texas 77024, United States

Urology San Antonio, San Antonio, Texas 78229, 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

Additional Information

Starting date: July 2004
Ending date: September 2007
Last updated: December 19, 2007

Page last updated: June 20, 2008

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