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| Sponsor: | Cell Genesys |
|---|---|
| Information provided by: | Cell Genesys |
| ClinicalTrials.gov Identifier: | NCT00133224 |
Purpose
The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine Drug: Chemotherapy (docetaxel 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 Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain |
| Enrollment: | 408 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | June 2009 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
|
| 2 |
Drug: Chemotherapy (docetaxel and prednisone)
Chemotherapy (docetaxel and prednisone)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alaska | |
| Alaska Clinical Research Center | |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arkansas | |
| St. Edward Mercy Medical Center | |
| Fort Smith, Arkansas, United States, 72917 | |
| United States, California | |
| Cancer Research & Prevention Center | |
| Soquel, California, United States, 95073 | |
| Onocology Care Medical Associates | |
| Los Angeles, California, United States, 90057 | |
| Kaiser Permanente Medical Group Dept. of Oncology Research | |
| San Diego, California, United States, 92120 | |
| Loma Linda University | |
| Loma Linda, California, United States, 92354 | |
| Sharp Healthcare | |
| San Diego, California, United States, 92123 | |
| UCSF Mt. Zion Cancer Center | |
| San Francisco, California, United States, 94115 | |
| California Pacific Medical Center | |
| San Francisco, California, United States, 94115 | |
| San Bernardino Urology Associates | |
| San Bernardino, California, United States, 92404 | |
| Desert Hematology Oncology Medical Group | |
| Rancho Mirage, California, United States, 92270 | |
| United States, Colorado | |
| Cancer Center and Department of Medicine | |
| Aurora, Colorado, United States, 80010 | |
| United States, Florida | |
| Hematology Oncology Associates of the Treasure Coast | |
| Port St. Lucie, Florida, United States, 34952 | |
| Lakeland Regional Cancer Center | |
| Lakeland, Florida, United States, 33804 | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| Jupiter Hematology & Oncology Associates | |
| Jupiter, Florida, United States, 33458 | |
| United States, Georgia | |
| Peachtree Hematology & Oncology Consultants, PC | |
| Atlanta, Georgia, United States, 30309 | |
| Emory Winship Cancer Institute | |
| Atlanta, Georgia, United States, 30322 | |
| Atlanta VA Medical Center | |
| Atlanta, Georgia, United States, 30033 | |
| United States, Illinois | |
| Medical & Surgical Specialists | |
| Galesburg, Illinois, United States, 61401 | |
| United States, Kentucky | |
| James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| Frederick Memorial Hospital Regional Cancer Therapy Center | |
| Frederick, Maryland, United States, 21701 | |
| United States, Michigan | |
| General Clinical Research Center University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Montana | |
| Billings Clinic | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Hematology & Oncology Consultants P.C. | |
| Omaha, Nebraska, United States, 68122 | |
| United States, Nevada | |
| Nevada Cancer Institute | |
| Las Vegas, Nevada, United States, 89135 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New Mexico | |
| New Mexico Oncology | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| North Shore Hematology Oncology Associates P.C. | |
| East Setauket, New York, United States, 11733 | |
| NYU Clinical Cancer Center | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Presbyterian Hospital Center for Cancer Research | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Ohio | |
| Gabrail Cancer Center | |
| Canton, Ohio, United States, 44718 | |
| United States, Oregon | |
| Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
| Kaiser Permanente Oncology/Hematology | |
| Portland, Oregon, United States, 97227 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Tennessee | |
| The West Clinic | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Center for Oncology Research & Treatment, PA | |
| Dallas, Texas, United States, 75230 | |
| Mobley Research Center | |
| Houston, Texas, United States, 77024 | |
| Dallas Oncology Consultants | |
| Dallas, Texas, United States, 75237 | |
| Northwest Cancer Center | |
| Houston, Texas, United States, 77042 | |
| Urology San Antonio Research, PA | |
| San Antonio, Texas, United States, 78229 | |
| Mary Crowley Medical Research Center | |
| Dallas, Texas, United States, 75246 | |
| United States, Washington | |
| Seattle Cancer Care Alliance, Univ. of Washington | |
| Seattle, Washington, United States, 98109 | |
| Belgium | |
| CHU de Liège - Hôpital du Sart Tilman | |
| Liège, Belgium, B-4000 | |
| AZ Groeninge | |
| Kortrijk, Belgium, B-8500 | |
| Ziekenhuis Netwerk Antwerpen - AZ Middelheim | |
| Antwerpen, Belgium, B-2020 | |
| Heilig-Hartziekenhuis Campus Wilgenstraat | |
| Roeselare, Belgium, B- 8800 | |
| Regionaal Ziekenhuis Sint Trudo | |
| Sint Truiden, Belgium, B-3800 | |
| V.Z.W. Imelda Ziekenhuis | |
| Bonheiden, Belgium, B-2820 | |
| Canada, Quebec | |
| Centre Hospitalier de L'Universite de Montreal | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Centre Hospitalier Universite de Sherbrooke | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| France | |
| Centre Regional de lutte contre le cancer Paul Papin | |
| Angers, France, 49033 | |
| Hopital Civil | |
| Strasbourg, France, 67091 | |
| Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer | |
| Nice, France, 06189 | |
| CHU Saint Louis | |
| Paris, France, 75010 | |
| Centre Alexis Vautrin | |
| Vandoeuvre les Nancy, France, 54500 | |
| Clinique Armoricaine de Radiology | |
| Saint Brieuc, France, 22015 | |
| Centre Rene Gauducheau - Site Hospitalier Nord | |
| Nantes, France, 44805 | |
| Centre Hospitalier Rene Dubos | |
| Pontoise, France, 95303 | |
| CHU Poitiers | |
| Poitiers, France, 86021 | |
| Centre Francois Baclesse | |
| Caen, France, 14076 | |
| CHU Bretonneau | |
| Tours, France, 37044 | |
| Hopital Cochin | |
| Paris, France, 75674 | |
| Hopital Saint Joseph Site Saint Michel | |
| Paris, France, 75015 | |
| Institut Jean Godinot, Oncologie Medicale | |
| Cedex, France, 51056 | |
| Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne | |
| Clermont-Ferrand, France, 63011 | |
| Germany | |
| Universitatsklinikum Aachen | |
| Aachen, Germany, 52074 | |
| Charite Campus Mitte | |
| Berlin, Germany, 10117 | |
| Krankenhaus Am Urban | |
| Berlin, Germany, 10967 | |
| Urologische Klinik und Poliklinik | |
| Munchen, Germany, 81675 | |
| Universitatsklinikum Carl Gustav Carus An Der | |
| Dresden, Germany, 01307 | |
| Klinikum der Johann Wolfgang Goethe-Universitat | |
| Frankfurt am Main, Germany, 60590 | |
| Klinikum Mannheim | |
| Mannheim, Germany, 68135 | |
| Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz | |
| Mainz, Germany, 55131 | |
| Italy | |
| Istituto Nazionale dei Tumori | |
| Milano, Italy, 20133 | |
| Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata | |
| Sassari, Italy, 07100 | |
| Fondazione IRCCS Ospedale Maggiore Policlinico | |
| Milan, Italy, 20122 | |
| Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara | |
| Pisa, Italy, 56126 | |
| Azienda Ospedaliera San Camillo Forlanini | |
| Roma, Italy, 00152 | |
| A.S.O. San Giovanni Battista di Torino | |
| Turin, Italy, 10126 | |
| Istituto Europeo di Oncologia | |
| Milan, Italy, 20141 | |
| Azienda Ospedaliera Maggiore della Carita | |
| Novarra, Italy, 28100 | |
| Azienda Ospedaliero Universitaria di Modena | |
| Modena, Italy, 41100 | |
| Azienda Ospedaliera di Parma | |
| Parma, Italy, 43100 | |
| Fondazione San Raffaele del Monte Tabor | |
| Milan, Italy, 20132 | |
| Netherlands | |
| Universitair Medisch Centrum Groningen | |
| Groningen, Netherlands, 9713 GZ | |
| Academisch Centrum | |
| Amsterdam, Netherlands, 1105 AZ | |
| VU Medisch Centrum | |
| Amsterdam, Netherlands, 1081 HV | |
| Poland | |
| Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie | |
| Warszawa, Poland, 02-781 | |
| Wojewodzki Szpital Specjalistyczny Oddzial Urologii | |
| Slupsk, Poland, 76-200 | |
| Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu | |
| Poznan, Poland, 61-848 | |
| Katedra i Klinika Onkologii i Radioterapli | |
| Gdansk, Poland, 80-952 | |
| Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Krakowie | |
| Krakow, Poland, 31-115 | |
| Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen | |
| Warszawa, Poland, 02-005 | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej | |
| Bytom, Poland, 41-902 | |
| Wojewodzki Szpital Specjalistyczny im. M. Kopernika | |
| Lodz, Poland, 93-509 | |
| Wojewodzki Szpital Specjalistyczny w Siedlcach | |
| Siedlce, Poland, 08-110 | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej | |
| Bialystok, Poland, 15-950 | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej | |
| Katowice, Poland, 40-073 | |
| Sweden | |
| Akademiska Sjukhuset i Uppsala | |
| Uppsala, Sweden, SE-75185 | |
| Universitetssjukhuset i Lund | |
| Lund, Sweden, SE-22185 | |
| University Hospital MAS (UMAS) | |
| Malmo, Sweden, SE-205 02 | |
| United Kingdom | |
| Royal Marsden Academic Urology Unit | |
| Sutton, United Kingdom, SM2 5PT | |
| Addenbrookes Hospital | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Mount Vernon Hospital | |
| Middlesex, United Kingdom, HA6 2RN | |
| Rosemere Cancer Centre, Royal Preston Hospital | |
| Preston, United Kingdom, PR2 9HT | |
| St. James University Hospital | |
| Leeds, United Kingdom, LS9 7TF | |
| Scunthorpe General Hospital, Dept of Oncology | |
| Scunthorpe, United Kingdom, DN15 7BH | |
| Lincoln County Hospital | |
| Lincoln, United Kingdom, LN2 4AX | |
| Royal Surrey County Hospital | |
| Guildford, United Kingdom, GU2 7XX | |
| Nottingham City Hospital | |
| Nottingham, United Kingdom, NG5 1PB | |
| Clatterbridge Centre For Oncology | |
| Wirral, United Kingdom, CH63 4JY | |
| Christie Hospital Manchester | |
| Manchester, United Kingdom, M20 4BX | |
| Department of Oncology Hammersmith Hospital | |
| London, United Kingdom, W12 0NN | |
| Royal Marsden Hospital | |
| London, United Kingdom, SW3 6JJ | |
More Information
| Responsible Party: | Cell Genesys, Inc. ( Cell Genesys, Inc. ) |
| Study ID Numbers: | G-0034, VITAL-2 |
| Study First Received: | August 19, 2005 |
| Last Updated: | September 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00133224 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Advanced Prostate Cancer HRPC Prostate Cancer Metastatic Hormone-refractory GVAX |
Chemotherapy Taxotere Docetaxel Prednisone Vaccine Allogeneic cells |
|
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 |
