Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients
NCT ID: NCT00133224
Last Updated: 2008-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
408 participants
INTERVENTIONAL
2005-07-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
2
Chemotherapy (docetaxel and prednisone)
Chemotherapy (docetaxel and prednisone)
Interventions
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Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Chemotherapy (docetaxel and prednisone)
Chemotherapy (docetaxel and prednisone)
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Cell Genesys
INDUSTRY
Responsible Party
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Cell Genesys, Inc.
Locations
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Alaska Clinical Research Center
Anchorage, Alaska, United States
St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States
Loma Linda University
Loma Linda, California, United States
Onocology Care Medical Associates
Los Angeles, California, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States
San Bernardino Urology Associates
San Bernardino, California, United States
Kaiser Permanente Medical Group Dept. of Oncology Research
San Diego, California, United States
Sharp Healthcare
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
UCSF Mt. Zion Cancer Center
San Francisco, California, United States
Cancer Research & Prevention Center
Soquel, California, United States
Cancer Center and Department of Medicine
Aurora, Colorado, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Jupiter Hematology & Oncology Associates
Jupiter, Florida, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
Atlanta VA Medical Center
Atlanta, Georgia, United States
Peachtree Hematology & Oncology Consultants, PC
Atlanta, Georgia, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Medical & Surgical Specialists
Galesburg, Illinois, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, United States
General Clinical Research Center University of Michigan
Ann Arbor, Michigan, United States
Billings Clinic
Billings, Montana, United States
Hematology & Oncology Consultants P.C.
Omaha, Nebraska, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New Mexico Oncology
Albuquerque, New Mexico, United States
North Shore Hematology Oncology Associates P.C.
East Setauket, New York, United States
NYU Clinical Cancer Center
New York, New York, United States
Presbyterian Hospital Center for Cancer Research
Charlotte, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Kaiser Permanente Oncology/Hematology
Portland, Oregon, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
The West Clinic
Memphis, Tennessee, United States
Center for Oncology Research & Treatment, PA
Dallas, Texas, United States
Dallas Oncology Consultants
Dallas, Texas, United States
Mary Crowley Medical Research Center
Dallas, Texas, United States
Mobley Research Center
Houston, Texas, United States
Northwest Cancer Center
Houston, Texas, United States
Urology San Antonio Research, PA
San Antonio, Texas, United States
Seattle Cancer Care Alliance, Univ. of Washington
Seattle, Washington, United States
Ziekenhuis Netwerk Antwerpen - AZ Middelheim
Antwerp, , Belgium
V.Z.W. Imelda Ziekenhuis
Bonheiden, , Belgium
AZ Groeninge
Kortrijk, , Belgium
CHU de Liège - Hôpital du Sart Tilman
Liège, , Belgium
Heilig-Hartziekenhuis Campus Wilgenstraat
Roeselare, , Belgium
Regionaal Ziekenhuis Sint Trudo
Sint-Truiden, , Belgium
Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, Canada
Centre Hospitalier Universite de Sherbrooke
Sherbrooke, Quebec, Canada
Centre Regional de lutte contre le cancer Paul Papin
Angers, , France
Centre Francois Baclesse
Caen, , France
Institut Jean Godinot, Oncologie Medicale
Cedex, , France
Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne
Clermont-Ferrand, , France
Centre Rene Gauducheau - Site Hospitalier Nord
Nantes, , France
Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer
Nice, , France
CHU Saint Louis
Paris, , France
Hopital Saint Joseph Site Saint Michel
Paris, , France
Hopital Cochin
Paris, , France
CHU Poitiers
Poitiers, , France
Centre Hospitalier Rene Dubos
Pontoise, , France
Clinique Armoricaine de Radiology
Saint-Brieuc, , France
Hopital Civil
Strasbourg, , France
CHU Bretonneau
Tours, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Universitatsklinikum Aachen
Aachen, , Germany
Charite Campus Mitte
Berlin, , Germany
Krankenhaus Am Urban
Berlin, , Germany
Universitatsklinikum Carl Gustav Carus An Der
Dresden, , Germany
Klinikum der Johann Wolfgang Goethe-Universitat
Frankfurt am Main, , Germany
Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz
Mainz, , Germany
Klinikum Mannheim
Mannheim, , Germany
Urologische Klinik und Poliklinik
München, , Germany
Fondazione IRCCS Ospedale Maggiore Policlinico
Milan, , Italy
Fondazione San Raffaele del Monte Tabor
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Istituto Nazionale dei Tumori
Milan, , Italy
Azienda Ospedaliero Universitaria di Modena
Modena, , Italy
Azienda Ospedaliera Maggiore della Carita
Novarra, , Italy
Azienda Ospedaliera di Parma
Parma, , Italy
Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara
Pisa, , Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, , Italy
Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata
Sassari, , Italy
A.S.O. San Giovanni Battista di Torino
Turin, , Italy
VU Medisch Centrum
Amsterdam, , Netherlands
Academisch Centrum
Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Bialystok, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Bytom, , Poland
Katedra i Klinika Onkologii i Radioterapli
Gdansk, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Katowice, , Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Krakowie
Krakow, , Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu
Poznan, , Poland
Wojewodzki Szpital Specjalistyczny w Siedlcach
Siedlce, , Poland
Wojewodzki Szpital Specjalistyczny Oddzial Urologii
Słupsk, , Poland
Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen
Warsaw, , Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie
Warsaw, , Poland
Universitetssjukhuset i Lund
Lund, , Sweden
University Hospital MAS (UMAS)
Malmo, , Sweden
Akademiska Sjukhuset i Uppsala
Uppsala, , Sweden
Addenbrookes Hospital
Cambridge, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
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
Christie Hospital Manchester
Manchester, , United Kingdom
Clatterbridge Centre For Oncology
Metropolitan Borough of Wirral, , United Kingdom
Mount Vernon Hospital
Middlesex, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Rosemere Cancer Centre, Royal Preston Hospital
Preston, , United Kingdom
Scunthorpe General Hospital, Dept of Oncology
Scunthorpe, , United Kingdom
Royal Marsden Academic Urology Unit
Sutton, , United Kingdom
Countries
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References
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Michael BD, Syndikus I, Clark A, Baborie A. Diffuse primary leptomeningeal melanocytosis in a patient receiving a novel cancer cell vaccine for prostate cancer. BMJ Case Rep. 2010 May 4;2010:bcr11.2009.2495. doi: 10.1136/bcr.11.2009.2495.
Other Identifiers
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VITAL-2
Identifier Type: -
Identifier Source: secondary_id
G-0034
Identifier Type: -
Identifier Source: org_study_id