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| Sponsor: | Cell Genesys |
|---|---|
| Information provided by: | Cell Genesys |
| ClinicalTrials.gov Identifier: | NCT00089856 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: Immunotherapy with allogeneic prostate vaccine Drug: Chemotherapy (Taxotere and prednisone) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 626 |
| Study Start Date: | July 2004 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
2
Standard of care - chemotherapy
|
Drug: Chemotherapy (Taxotere and prednisone)
Chemotherapy (Taxotere and prednisone)
|
|
1: Experimental
Immunotherapy
|
Biological: Immunotherapy with allogeneic prostate vaccine
Immunotherapy with allogeneic prostate vaccine
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Central Alabama Oncology, LLC | |
| Alabaster, Alabama, United States, 35007 | |
| United States, Alaska | |
| Alaska Clinical Research Center | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arizona | |
| Palo Verde Hematology/Oncology | |
| Glendale, Arizona, United States, 85304 | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259 | |
| ACRC/Arizona Clinical Res. Ctr. Inc. | |
| Tuscon, Arizona, United States, 85715 | |
| United States, Arkansas | |
| Arkansas Cancer Research Center | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Sharp Healthcare | |
| San Diego, California, United States, 92123 | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| Pacific Coast Hem Onc. Medical Group | |
| Fountain Valley, California, United States, 92708 | |
| Cancer Research & Prevention Center | |
| Soquel, California, United States, 95073 | |
| California Cancer Care | |
| Greenbrae, California, United States, 94904 | |
| Oncology Care Medical Associates | |
| Montebello, California, United States, 90640 | |
| San Diego Cancer Center | |
| Vista, California, United States, 92081 | |
| Center for Urological Research | |
| La Mesa, California, United States, 91942 | |
| Compassionate Cancer Care Medical Group, Inc. | |
| Corona, California, United States, 92882 | |
| UC Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| San Bernardino Urological Associates | |
| San Bernardino, California, United States, 92404 | |
| United States, Colorado | |
| Cancer Center of Colorado Springs | |
| Colorado Springs, Colorado, United States, 80907 | |
| Univ. of Colorado Health Science Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Urology Center of Grove Hill | |
| New Britain, Connecticut, United States, 06052-1395 | |
| Carl & Dorothy Bennett Cancer Center | |
| Stamford, Connecticut, United States, 06902 | |
| The Hope Clinic | |
| Bristol, Connecticut, United States, 06010 | |
| United States, Florida | |
| Cancer Centers of Florida | |
| Ocoee, Florida, United States, 34761 | |
| Hematology Oncology Associates of the Treasure Coast | |
| Port St. Lucie, Florida, United States, 34952 | |
| Urology Consultants | |
| Safety Harbor, Florida, United States, 34695 | |
| Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Boca Raton Community Hospital, Inc. | |
| Boca Raton, Florida, United States, 33486 | |
| Integrated Community Oncology Network | |
| Jacksonville, Florida, United States, 32256 | |
| Oncology-Hematology Group of South Florida/Advanced Medical Specialists | |
| Miami, Florida, United States, 33176 | |
| United States, Georgia | |
| Central Georgia Cancer Care, P.C. | |
| Macon, Georgia, United States, 31201 | |
| Georgia Cancer Specialists | |
| Atlanta, Georgia, United States, 30084 | |
| Winship Cancer Institute, Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| Peachtree Hematology Oncology Consultants, PC | |
| Atlanta, Georgia, United States, 30309 | |
| Atlanta VAMC | |
| Atlanta, Georgia, United States, 30033 | |
| United States, Hawaii | |
| Straub Clinic & Hospital | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Welborn Clinic Research Center | |
| Evansville, Indiana, United States, 47713 | |
| Fort Wayne Medical Oncology/Hematology Inc. | |
| Fort Wayne, Indiana, United States, 46815 | |
| United States, Louisiana | |
| Louisiana Oncology Associates | |
| Lafayette, Louisiana, United States, 70506 | |
| United States, Maryland | |
| Frederick Memorial Hospital Regional Cancer Therapy Center | |
| Frederick, Maryland, United States, 21701 | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Michigan | |
| William Beaumont Hospital, Cancer Clinical Trials Office | |
| Royal Oak, Michigan, United States, 48073-6706 | |
| West Michigan Regional Cancer and Blood Center | |
| Free Soil, Michigan, United States, 49411 | |
| Newland Medical Associates, P.C. | |
| Southfield, Michigan, United States, 48075 | |
| United States, Missouri | |
| Hematology Oncology Consultants, Inc. | |
| St. Louis, Missouri, United States, 63136 | |
| United States, Montana | |
| Hematology/Oncology Centers of the Northern Rockies, P.C. | |
| Billings, Montana, United States, 59101 | |
| Deaconess Billings Clinic | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Omaha VA Medical Center | |
| Omaha, Nebraska, United States, 68198-7680 | |
| Omaha VA Medical Center | |
| Omaha, Nebraska, United States, 68105 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Hematology-Oncology Associates of Northern New Jersey | |
| Morristown, New Jersey, United States, 07962 | |
| Summit Medical Group/Overlook Oncology Center | |
| Summit, New Jersey, United States, 07901 | |
| The Center for Cancer & Hematologic Disease | |
| Cherry Hill, New Jersey, United States, 08003 | |
| United States, New York | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Jacobi Medical Center | |
| Bronx, New York, United States, 10461 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Northwestern Carolina Hematology Oncology, PA | |
| Hickory, North Carolina, United States, 28602 | |
| Presbyterian Hospital/ Center for Cancer Research | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, North Dakota | |
| Medcenter One Cancer Care / Odyssey Research | |
| Bismarck, North Dakota, United States, 58501 | |
| Dakota Cancer Institute | |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| Gabrail Cancer Center | |
| Canton, Ohio, United States, 44718 | |
| Cleveland Clinic Foundation, Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oklahoma | |
| University of Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Medical Oncology Associates | |
| Kingston, Pennsylvania, United States, 18704 | |
| Urological Associates of Lancaster | |
| Lancaster, Pennsylvania, United States, 17604 | |
| University of Pittsburgh Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Lancaster Cancer Center, Ltd | |
| Lancaster, Pennsylvania, United States, 17601 | |
| Urologic Surgery PC | |
| Bala Cynwyd, Pennsylvania, United States, 19004 | |
| United States, South Carolina | |
| Charleston Hematology Oncology | |
| Charleston, South Carolina, United States, 29403 | |
| United States, Tennessee | |
| The West Clinic | |
| Memphis, Tennessee, United States, 38120 | |
| Memorial Health Care System | |
| Chattanooga, Tennessee, United States, 37404 | |
| United States, Texas | |
| Mary Crowley Medical Research Center | |
| Dallas, Texas, United States, 75201 | |
| Tyler Cancer Center | |
| Tyler, Texas, United States, 75702 | |
| Urology Specialists and Associates, P.A. | |
| Dallas, Texas, United States, 75231 | |
| Mobley Research Center | |
| Houston, Texas, United States, 77024 | |
| Urology San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| The Don and Sybil Harrington Cancer Center | |
| Amarillo, Texas, United States, 79106 | |
| Center for Oncology Research and Treatment PA | |
| Dallas, Texas, United States, 75230 | |
| Urology San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| United States, Vermont | |
| Southwestern Oncology Research Department | |
| Bennington, Vermont, United States, 05201 | |
| United States, Virginia | |
| Virginia Oncology Associates | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Virginia Mason Medical Center Urology | |
| Seattle, Washington, United States, 98101 | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109 | |
| Belgium | |
| Virga Jesse Ziekenhuis | |
| Hasselt, Belgium, B-3500 | |
| AZ Groeninge | |
| Kortrijk, Belgium, B-8500 | |
| ZNA Middelheim | |
| Antwerp, Belgium, B-2020 | |
| Regionaal Ziekenhuis Sint Trudo | |
| Sint-Truiden, Belgium, B-3800 | |
| Heilig Hartziekenhuis Roeselare Men | |
| Roeselare, Belgium, B-8800 | |
| University Hospital Antwerp (UZA) | |
| Edegem, Belgium, 2650 | |
| Imelda Ziekenhuis | |
| Bonheiden, Belgium, 2820 | |
| UZ Gent | |
| Gent, Belgium, 9000 | |
| Unversity Hospial Gent | |
| Gent, Belgium, B-9000 | |
| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| CHUM Notre-Dam | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| McGill University | |
| Montreal, Quebec, Canada, H2W1S6 | |
| Ultra Med Inc. | |
| Pointe-Claire, Quebec, Canada, H9R 4S3 | |
| Centre Hopitalier Universitaire de Sherbrooke | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| France | |
| Centre Alexis Vautrin | |
| Vandoeuvre les Nancy Cedex, France, 54511 | |
| Centre Francois Baclesse | |
| Caen Cedex 5, France, 14076 | |
| Institut Jean Godinot | |
| Reims Cedex, France, 51056 | |
| Centre Paul Papin | |
| Angers Cedex, France, 49033 | |
| Centre Georges Francois Leclerc | |
| Dijon Cedex, France, 77980 | |
| Centre Rene Gauducheau | |
| Nantes-Saint Herblain, France, 44805 | |
| Institut Paoli-Calmettes | |
| Marseille, France, 13009 | |
| Centre Leon Berard Service de Cancerologie Medicale | |
| Lyon Cedex, France, 08 | |
| Germany | |
| Universitatsklinik um Essen | |
| Essen, Germany, 45122 | |
| der Technischen Universitat Dresden | |
| Dresden, Germany, 1307 | |
| Universitatsklinik um des Saarlande | |
| Homburg/Saar, Germany, 66421 | |
| Universitatsklinikum Aachen Urologie | |
| Aachen, Germany, 52074 | |
| Netherlands | |
| University Medical Centre Groningen | |
| Groningen, Netherlands | |
| VU Medisch Centrum | |
| Amsterdam, Netherlands, 1081 HV | |
| Sweden | |
| Akademiska University Hospital | |
| Uppsala, Sweden, 85 | |
| University Hospital Lund | |
| Lund, Sweden | |
| University Hospital, Linkoping | |
| Linkoping, Sweden | |
| United Kingdom | |
| Beatson Oncology Centre | |
| Glasgow, United Kingdom, G11 6NT | |
| St. James's University Hospital | |
| Leeds, United Kingdom, LS97TF | |
| Newcastle General Hospital | |
| Newcastle upon Tyne, United Kingdom, NE4 6BE | |
| Royal Hallamshire Hospital | |
| Sheffield, United Kingdom, S10 2JF | |
| Scunthorpe General Hospital | |
| Scunthorpe, United Kingdom, DN15 7BH | |
| Hammersmith Hospital | |
| London, United Kingdom, W12 0NN | |
| Oxford Cancer Centre, Churchill Hospital | |
| Oxford, United Kingdom, OX3 7LT | |
| Addenbrooke's Hospital | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Mount Vernon Hospital | |
| Middlesex, United Kingdom, HA6 2RN | |
| Glan Clwyd Hospital | |
| Wales, United Kingdom, LL18 5UJ | |
| Northampton General Hosptial | |
| Northampton, United Kingdom, NN1 5BD | |
| Nottingham City Hospital | |
| Nottingham, United Kingdom, NG5 1PB | |
More Information
| Responsible Party: | Cell Genesys, Inc. ( Cell Genesys, Inc ) |
| Study ID Numbers: | G-0029, (VITAL-1) |
| Study First Received: | August 16, 2004 |
| Last Updated: | November 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00089856 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Prostate Cancer Metastatic Hormone-refractory GVAX Chemotherapy |
Taxotere Docetaxel Prednisone Vaccine Allogeneic cells Advanced Prostate Cancer |
|
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms |
Genital Diseases, Male Glucocorticoids Hormones Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |
