Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients

September 19, 2008 updated by: Cell Genesys

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

408

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, B-2020
        • Ziekenhuis Netwerk Antwerpen - AZ Middelheim
      • Bonheiden, Belgium, B-2820
        • V.Z.W. Imelda Ziekenhuis
      • Kortrijk, Belgium, B-8500
        • Az Groeninge
      • Liège, Belgium, B-4000
        • CHU de Liège - Hôpital du Sart Tilman
      • Roeselare, Belgium, B- 8800
        • Heilig-Hartziekenhuis Campus Wilgenstraat
      • Sint Truiden, Belgium, B-3800
        • Regionaal Ziekenhuis Sint Trudo
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de l'Universite de Montreal
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universite de Sherbrooke
  • France
      • Angers, France, 49033
        • Centre Regional de lutte contre le cancer Paul Papin
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Cedex, France, 51056
        • Institut Jean Godinot, Oncologie Medicale
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne
      • Nantes, France, 44805
        • Centre Rene Gauducheau - Site Hospitalier Nord
      • Nice, France, 06189
        • Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer
      • Paris, France, 75674
        • Hopital Cochin
      • Paris, France, 75010
        • CHU Saint Louis
      • Paris, France, 75015
        • Hopital Saint Joseph Site Saint Michel
      • Poitiers, France, 86021
        • CHU Poitiers
      • Pontoise, France, 95303
        • Centre Hospitalier Rene Dubos
      • Saint Brieuc, France, 22015
        • Clinique Armoricaine de Radiology
      • Strasbourg, France, 67091
        • Hôpital Civil
      • Tours, France, 37044
        • CHU Bretonneau
      • Vandoeuvre les Nancy, France, 54500
        • Centre Alexis Vautrin
  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinikum Aachen
      • Berlin, Germany, 10117
        • Charité Campus Mitte
      • Berlin, Germany, 10967
        • Krankenhaus Am Urban
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus an der
      • Frankfurt am Main, Germany, 60590
        • Klinikum der Johann Wolfgang Goethe-Universität
      • Mainz, Germany, 55131
        • Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz
      • Mannheim, Germany, 68135
        • Klinikum Mannheim
      • Munchen, Germany, 81675
        • Urologische Klinik und Poliklinik
  • Italy
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milan, Italy, 20132
        • Fondazione San Raffaele del Monte Tabor
      • Milan, Italy, 20122
        • Fondazione IRCCS Ospedale Maggiore Policlinico
      • Milano, Italy, 20133
        • Istituto Nazionale dei Tumori
      • Modena, Italy, 41100
        • Azienda Ospedaliero Universitaria di Modena
      • Novarra, Italy, 28100
        • Azienda Ospedaliera Maggiore Della Carita
      • Parma, Italy, 43100
        • Azienda Ospedaliera Di Parma
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara
      • Roma, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini
      • Sassari, Italy, 07100
        • Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata
      • Turin, Italy, 10126
        • A.S.O. San Giovanni Battista di Torino
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU Medisch Centrum
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Centrum
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen
  • Poland
      • Bialystok, Poland, 15-950
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej
      • Bytom, Poland, 41-902
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej
      • Gdansk, Poland, 80-952
        • Katedra i Klinika Onkologii i Radioterapli
      • Katowice, Poland, 40-073
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej
      • Krakow, Poland, 31-115
        • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Krakowie
      • Lodz, Poland, 93-509
        • Wojewodzki Szpital Specjalistyczny im. M. Kopernika
      • Poznan, Poland, 61-848
        • Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu
      • Siedlce, Poland, 08-110
        • Wojewodzki Szpital Specjalistyczny w Siedlcach
      • Slupsk, Poland, 76-200
        • Wojewodzki Szpital Specjalistyczny Oddzial Urologii
      • Warszawa, Poland, 02-005
        • Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen
      • Warszawa, Poland, 02-781
        • Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie
  • Sweden
      • Lund, Sweden, SE-22185
        • Universitetssjukhuset i Lund
      • Malmo, Sweden, SE-205 02
        • University Hospital MAS (UMAS)
      • Uppsala, Sweden, SE-75185
        • Akademiska Sjukhuset i Uppsala
  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
        • Addenbrookes Hospital
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St. James University Hospital
      • Lincoln, United Kingdom, LN2 4AX
        • Lincoln County Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
      • London, United Kingdom, W12 0NN
        • Department of Oncology Hammersmith Hospital
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital Manchester
      • Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Preston, United Kingdom, PR2 9HT
        • Rosemere Cancer Centre, Royal Preston Hospital
      • Scunthorpe, United Kingdom, DN15 7BH
        • Scunthorpe General Hospital, Dept of Oncology
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Academic Urology Unit
      • Wirral, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Clinical Research Center
    • Arkansas
      • Fort Smith, Arkansas, United States, 72917
        • St. Edward Mercy Medical Center
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University
      • Los Angeles, California, United States, 90057
        • Onocology Care Medical Associates
      • Rancho Mirage, California, United States, 92270
        • Desert Hematology Oncology Medical Group
      • San Bernardino, California, United States, 92404
        • San Bernardino Urology Associates
      • San Diego, California, United States, 92123
        • Sharp HealthCare
      • San Diego, California, United States, 92120
        • Kaiser Permanente Medical Group Dept. of Oncology Research
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
      • San Francisco, California, United States, 94115
        • UCSF Mt. Zion Cancer Center
      • Soquel, California, United States, 95073
        • Cancer Research & Prevention Center
    • Colorado
      • Aurora, Colorado, United States, 80010
        • Cancer Center and Department of Medicine
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Jacksonville
      • Jupiter, Florida, United States, 33458
        • Jupiter Hematology & Oncology Associates
      • Lakeland, Florida, United States, 33804
        • Lakeland Regional Cancer Center
      • Port St. Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of the Treasure Coast
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Winship Cancer Institute
      • Atlanta, Georgia, United States, 30033
        • Atlanta VA Medical Center
      • Atlanta, Georgia, United States, 30309
        • Peachtree Hematology & Oncology Consultants, Pc
    • Illinois
      • Galesburg, Illinois, United States, 61401
        • Medical & Surgical Specialists
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center
    • Maryland
      • Frederick, Maryland, United States, 21701
        • Frederick Memorial Hospital Regional Cancer Therapy Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • General Clinical Research Center University of Michigan
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68122
        • Hematology & Oncology Consultants P.C.
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Oncology
    • New York
      • East Setauket, New York, United States, 11733
        • North Shore Hematology Oncology Associates P.C.
      • New York, New York, United States, 10016
        • Nyu Clinical Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital Center for Cancer Research
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Oncology/Hematology
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
    • Texas
      • Dallas, Texas, United States, 75246
        • Mary Crowley Medical Research Center
      • Dallas, Texas, United States, 75230
        • Center for Oncology Research & Treatment, PA
      • Dallas, Texas, United States, 75237
        • Dallas Oncology Consultants
      • Houston, Texas, United States, 77024
        • Mobley Research Center
      • Houston, Texas, United States, 77042
        • Northwest Cancer Center
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research, PA
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance, Univ. of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Other: 2
Drug: Chemotherapy (docetaxel and prednisone)
Chemotherapy (docetaxel and prednisone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival

Secondary Outcome Measures

Outcome Measure
Time to disease progression. Time to pain progression.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cell Genesys

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

August 19, 2005

First Submitted That Met QC Criteria

August 19, 2005

First Posted (Estimate)

August 23, 2005

Study Record Updates

Last Update Posted (Estimate)

September 23, 2008

Last Update Submitted That Met QC Criteria

September 19, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G-0034
  • VITAL-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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