Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
- Conditions
- Prostate Cancer
- Interventions
- Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccineDrug: Chemotherapy (docetaxel and prednisone)
- Registration Number
- NCT00133224
- Lead Sponsor
- Cell Genesys
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 408
- 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
- ECOG performance status ≤2 (Performance status of 3 if due to bone pain)
- Any Gleason score
- Only one prior treatment with systemic chemotherapy
- No prior treatment with gene therapy
- No prior immunotherapy for prostate cancer
- Taxane naïve
- Experiencing cancer-related pain
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Immunotherapy allogeneic GM-CSF secreting cellular vaccine - 2 Chemotherapy (docetaxel and prednisone) -
- Primary Outcome Measures
Name Time Method Survival 0
- Secondary Outcome Measures
Name Time Method Time to disease progression. Time to pain progression. 0
Trial Locations
- Locations (113)
Loma Linda University
🇺🇸Loma Linda, California, United States
St. Edward Mercy Medical Center
🇺🇸Fort Smith, Arkansas, United States
Wojewodzki Szpital Specjalistyczny w Siedlcach
🇵🇱Siedlce, Poland
Onocology Care Medical Associates
🇺🇸Los Angeles, California, United States
Atlanta VA Medical Center
🇺🇸Atlanta, Georgia, United States
Kaiser Permanente Medical Group Dept. of Oncology Research
🇺🇸San Diego, California, United States
UCSF Mt. Zion Cancer Center
🇺🇸San Francisco, California, United States
Billings Clinic
🇺🇸Billings, Montana, United States
AZ Groeninge
🇧🇪Kortrijk, Belgium
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Medical & Surgical Specialists
🇺🇸Galesburg, Illinois, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Presbyterian Hospital Center for Cancer Research
🇺🇸Charlotte, North Carolina, United States
North Shore Hematology Oncology Associates P.C.
🇺🇸East Setauket, New York, United States
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Roma, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer
🇫🇷Nice, France
Centre Hospitalier Rene Dubos
🇫🇷Pontoise, France
Dallas Oncology Consultants
🇺🇸Dallas, Texas, United States
NYU Clinical Cancer Center
🇺🇸New York, New York, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Hematology & Oncology Consultants P.C.
🇺🇸Omaha, Nebraska, United States
Jupiter Hematology & Oncology Associates
🇺🇸Jupiter, Florida, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
🇺🇸Frederick, Maryland, United States
Regionaal Ziekenhuis Sint Trudo
🇧🇪Sint Truiden, Belgium
Center for Oncology Research & Treatment, PA
🇺🇸Dallas, Texas, United States
Mary Crowley Medical Research Center
🇺🇸Dallas, Texas, United States
Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
V.Z.W. Imelda Ziekenhuis
🇧🇪Bonheiden, Belgium
Kaiser Permanente Oncology/Hematology
🇺🇸Portland, Oregon, United States
Fondazione San Raffaele del Monte Tabor
🇮🇹Milan, Italy
Istituto Europeo di Oncologia
🇮🇹Milan, Italy
Klinikum der Johann Wolfgang Goethe-Universitat
🇩🇪Frankfurt am Main, Germany
Azienda Ospedaliera Maggiore della Carita
🇮🇹Novarra, Italy
Peachtree Hematology & Oncology Consultants, PC
🇺🇸Atlanta, Georgia, United States
Centre Francois Baclesse
🇫🇷Caen, France
Scunthorpe General Hospital, Dept of Oncology
🇬🇧Scunthorpe, United Kingdom
Centre Hospitalier Universite de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Centre Hospitalier de L'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Azienda Ospedaliera di Parma
🇮🇹Parma, Italy
Christie Hospital Manchester
🇬🇧Manchester, United Kingdom
Krankenhaus Am Urban
🇩🇪Berlin, Germany
A.S.O. San Giovanni Battista di Torino
🇮🇹Turin, Italy
Hopital Saint Joseph Site Saint Michel
🇫🇷Paris, France
Mount Vernon Hospital
🇬🇧Middlesex, United Kingdom
Klinikum Mannheim
🇩🇪Mannheim, Germany
Universitatsklinikum Aachen
🇩🇪Aachen, Germany
CHU Poitiers
🇫🇷Poitiers, France
Charite Campus Mitte
🇩🇪Berlin, Germany
Azienda Ospedaliero Universitaria di Modena
🇮🇹Modena, Italy
Centre Alexis Vautrin
🇫🇷Vandoeuvre les Nancy, France
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Rosemere Cancer Centre, Royal Preston Hospital
🇬🇧Preston, United Kingdom
Royal Marsden Academic Urology Unit
🇬🇧Sutton, United Kingdom
Clatterbridge Centre For Oncology
🇬🇧Wirral, United Kingdom
Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz
🇩🇪Mainz, Germany
Urologische Klinik und Poliklinik
🇩🇪Munchen, Germany
Centre Regional de lutte contre le cancer Paul Papin
🇫🇷Angers, France
Institut Jean Godinot, Oncologie Medicale
🇫🇷Cedex, France
Hopital Cochin
🇫🇷Paris, France
Clinique Armoricaine de Radiology
🇫🇷Saint Brieuc, France
Lakeland Regional Cancer Center
🇺🇸Lakeland, Florida, United States
Mobley Research Center
🇺🇸Houston, Texas, United States
Northwest Cancer Center
🇺🇸Houston, Texas, United States
Cancer Center and Department of Medicine
🇺🇸Aurora, Colorado, United States
Alaska Clinical Research Center
🇺🇸Anchorage, Alaska, United States
Desert Hematology Oncology Medical Group
🇺🇸Rancho Mirage, California, United States
San Bernardino Urology Associates
🇺🇸San Bernardino, California, United States
Cancer Research & Prevention Center
🇺🇸Soquel, California, United States
Hematology Oncology Associates of the Treasure Coast
🇺🇸Port St. Lucie, Florida, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Emory Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
General Clinical Research Center University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
CHU de Liège - Hôpital du Sart Tilman
🇧🇪Liège, Belgium
Ziekenhuis Netwerk Antwerpen - AZ Middelheim
🇧🇪Antwerpen, Belgium
Heilig-Hartziekenhuis Campus Wilgenstraat
🇧🇪Roeselare, Belgium
Urology San Antonio Research, PA
🇺🇸San Antonio, Texas, United States
Hopital Civil
🇫🇷Strasbourg, France
CHU Bretonneau
🇫🇷Tours, France
Centre Rene Gauducheau - Site Hospitalier Nord
🇫🇷Nantes, France
Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne
🇫🇷Clermont-Ferrand, France
CHU Saint Louis
🇫🇷Paris, France
Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Universitatsklinikum Carl Gustav Carus An Der
🇩🇪Dresden, Germany
Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara
🇮🇹Pisa, Italy
Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata
🇮🇹Sassari, Italy
Academisch Centrum
🇳🇱Amsterdam, Netherlands
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
🇵🇱Katowice, Poland
Wojewodzki Szpital Specjalistyczny Oddzial Urologii
🇵🇱Slupsk, Poland
VU Medisch Centrum
🇳🇱Amsterdam, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Krakowie
🇵🇱Krakow, Poland
Katedra i Klinika Onkologii i Radioterapli
🇵🇱Gdansk, Poland
Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen
🇵🇱Warszawa, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
🇵🇱Lodz, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu
🇵🇱Poznan, Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie
🇵🇱Warszawa, Poland
Universitetssjukhuset i Lund
🇸🇪Lund, Sweden
University Hospital MAS (UMAS)
🇸🇪Malmo, Sweden
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
Akademiska Sjukhuset i Uppsala
🇸🇪Uppsala, Sweden
St. James University Hospital
🇬🇧Leeds, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, United Kingdom
Royal Marsden Hospital
🇬🇧London, United Kingdom
Department of Oncology Hammersmith Hospital
🇬🇧London, United Kingdom
New Mexico Oncology
🇺🇸Albuquerque, New Mexico, United States
Seattle Cancer Care Alliance, Univ. of Washington
🇺🇸Seattle, Washington, United States
Sharp Healthcare
🇺🇸San Diego, California, United States