GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

NCT ID: NCT00089856

Last Updated: 2008-11-05

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

626 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Prostate Cancer Metastatic Hormone-refractory GVAX Chemotherapy Taxotere Docetaxel Prednisone Vaccine Allogeneic cells Advanced Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2

Standard of care - chemotherapy

Group Type OTHER

Chemotherapy (Taxotere and prednisone)

Intervention Type DRUG

Chemotherapy (Taxotere and prednisone)

1

Immunotherapy

Group Type EXPERIMENTAL

Immunotherapy with allogeneic prostate vaccine

Intervention Type BIOLOGICAL

Immunotherapy with allogeneic prostate vaccine

Interventions

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Immunotherapy with allogeneic prostate vaccine

Immunotherapy with allogeneic prostate vaccine

Intervention Type BIOLOGICAL

Chemotherapy (Taxotere and prednisone)

Chemotherapy (Taxotere and prednisone)

Intervention Type DRUG

Eligibility Criteria

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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
* Any Gleason score
* ECOG performance status 0-2

Exclusion Criteria

* Prior treatment with chemotherapy
* Prior Immunotherapy
* Prior treatment with gene therapy
* Significant cancer related pain
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cell Genesys

INDUSTRY

Sponsor Role lead

Responsible Party

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Cell Genesys, Inc.

Locations

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Central Alabama Oncology, LLC

Alabaster, Alabama, United States

Site Status

Alaska Clinical Research Center

Anchorage, Alaska, United States

Site Status

Palo Verde Hematology/Oncology

Glendale, Arizona, United States

Site Status

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

ACRC/Arizona Clinical Res. Ctr. Inc.

Tuscon, Arizona, United States

Site Status

Arkansas Cancer Research Center

Little Rock, Arkansas, United States

Site Status

Compassionate Cancer Care Medical Group, Inc.

Corona, California, United States

Site Status

Pacific Coast Hem Onc. Medical Group

Fountain Valley, California, United States

Site Status

California Cancer Care

Greenbrae, California, United States

Site Status

Center for Urological Research

La Mesa, California, United States

Site Status

Oncology Care Medical Associates

Montebello, California, United States

Site Status

UC Irvine Medical Center

Orange, California, United States

Site Status

San Bernardino Urological Associates

San Bernardino, California, United States

Site Status

Sharp Healthcare

San Diego, California, United States

Site Status

California Pacific Medical Center

San Francisco, California, United States

Site Status

Cancer Research & Prevention Center

Soquel, California, United States

Site Status

San Diego Cancer Center

Vista, California, United States

Site Status

Univ. of Colorado Health Science Center

Aurora, Colorado, United States

Site Status

Cancer Center of Colorado Springs

Colorado Springs, Colorado, United States

Site Status

The Hope Clinic

Bristol, Connecticut, United States

Site Status

Urology Center of Grove Hill

New Britain, Connecticut, United States

Site Status

Carl & Dorothy Bennett Cancer Center

Stamford, Connecticut, United States

Site Status

Boca Raton Community Hospital, Inc.

Boca Raton, Florida, United States

Site Status

Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

Integrated Community Oncology Network

Jacksonville, Florida, United States

Site Status

Oncology-Hematology Group of South Florida/Advanced Medical Specialists

Miami, Florida, United States

Site Status

Cancer Centers of Florida

Ocoee, Florida, United States

Site Status

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Site Status

Urology Consultants

Safety Harbor, Florida, United States

Site Status

Atlanta VAMC

Atlanta, Georgia, United States

Site Status

Georgia Cancer Specialists

Atlanta, Georgia, United States

Site Status

Peachtree Hematology Oncology Consultants, PC

Atlanta, Georgia, United States

Site Status

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Site Status

Central Georgia Cancer Care, P.C.

Macon, Georgia, United States

Site Status

Straub Clinic & Hospital

Honolulu, Hawaii, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Welborn Clinic Research Center

Evansville, Indiana, United States

Site Status

Fort Wayne Medical Oncology/Hematology Inc.

Fort Wayne, Indiana, United States

Site Status

Louisiana Oncology Associates

Lafayette, Louisiana, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Frederick Memorial Hospital Regional Cancer Therapy Center

Frederick, Maryland, United States

Site Status

West Michigan Regional Cancer and Blood Center

Free Soil, Michigan, United States

Site Status

William Beaumont Hospital, Cancer Clinical Trials Office

Royal Oak, Michigan, United States

Site Status

Newland Medical Associates, P.C.

Southfield, Michigan, United States

Site Status

Hematology Oncology Consultants, Inc.

St Louis, Missouri, United States

Site Status

Deaconess Billings Clinic

Billings, Montana, United States

Site Status

Hematology/Oncology Centers of the Northern Rockies, P.C.

Billings, Montana, United States

Site Status

Omaha VA Medical Center

Omaha, Nebraska, United States

Site Status

Omaha VA Medical Center

Omaha, Nebraska, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

The Center for Cancer & Hematologic Disease

Cherry Hill, New Jersey, United States

Site Status

Hematology-Oncology Associates of Northern New Jersey

Morristown, New Jersey, United States

Site Status

Summit Medical Group/Overlook Oncology Center

Summit, New Jersey, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Jacobi Medical Center

The Bronx, New York, United States

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Presbyterian Hospital/ Center for Cancer Research

Charlotte, North Carolina, United States

Site Status

Northwestern Carolina Hematology Oncology, PA

Hickory, North Carolina, United States

Site Status

Medcenter One Cancer Care / Odyssey Research

Bismarck, North Dakota, United States

Site Status

Dakota Cancer Institute

Fargo, North Dakota, United States

Site Status

Gabrail Cancer Center

Canton, Ohio, United States

Site Status

Cleveland Clinic Foundation, Taussig Cancer Center

Cleveland, Ohio, United States

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University of Oklahoma

Oklahoma City, Oklahoma, United States

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Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Urologic Surgery PC

Bala-Cynwyd, Pennsylvania, United States

Site Status

Medical Oncology Associates

Kingston, Pennsylvania, United States

Site Status

Lancaster Cancer Center, Ltd

Lancaster, Pennsylvania, United States

Site Status

Urological Associates of Lancaster

Lancaster, Pennsylvania, United States

Site Status

University of Pittsburgh Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Charleston Hematology Oncology

Charleston, South Carolina, United States

Site Status

Memorial Health Care System

Chattanooga, Tennessee, United States

Site Status

The West Clinic

Memphis, Tennessee, United States

Site Status

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, United States

Site Status

Mary Crowley Medical Research Center

Dallas, Texas, United States

Site Status

Center for Oncology Research and Treatment PA

Dallas, Texas, United States

Site Status

Urology Specialists and Associates, P.A.

Dallas, Texas, United States

Site Status

Mobley Research Center

Houston, Texas, United States

Site Status

Urology San Antonio

San Antonio, Texas, United States

Site Status

Tyler Cancer Center

Tyler, Texas, United States

Site Status

Southwestern Oncology Research Department

Bennington, Vermont, United States

Site Status

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status

Virginia Mason Medical Center Urology

Seattle, Washington, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

ZNA Middelheim

Antwerp, , Belgium

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Imelda Ziekenhuis

Bonheiden, , Belgium

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University Hospital Antwerp (UZA)

Edegem, , Belgium

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UZ Gent

Ghent, , Belgium

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Unversity Hospial Gent

Ghent, , Belgium

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Virga Jesse Ziekenhuis

Hasselt, , Belgium

Site Status

AZ Groeninge

Kortrijk, , Belgium

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Heilig Hartziekenhuis Roeselare Men

Roeselare, , Belgium

Site Status

Regionaal Ziekenhuis Sint Trudo

Sint-Truiden, , Belgium

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Princess Margaret Hospital

Toronto, Ontario, Canada

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CHUM Notre-Dam

Montreal, Quebec, Canada

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McGill University

Montreal, Quebec, Canada

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Ultra Med Inc.

Pointe-Claire, Quebec, Canada

Site Status

Centre Hopitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

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Centre Paul Papin

Angers, , France

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Centre Francois Baclesse

Caen, , France

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Centre Georges Francois Leclerc

Dijon, , France

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Centre Leon Berard Service de Cancerologie Medicale

Lyon, , France

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Institut Paoli-Calmettes

Marseille, , France

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Centre Rene Gauducheau

Nantes-Saint Herblain, , France

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Institut Jean Godinot

Reims, , France

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Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Site Status

Universitatsklinikum Aachen Urologie

Aachen, , Germany

Site Status

der Technischen Universitat Dresden

Dresden, , Germany

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Universitatsklinik um Essen

Essen, , Germany

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Universitatsklinik um des Saarlande

Homburg/Saar, , Germany

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VU Medisch Centrum

Amsterdam, , Netherlands

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University Medical Centre Groningen

Groningen, , Netherlands

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University Hospital, Linkoping

Linköping, , Sweden

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University Hospital Lund

Lund, , Sweden

Site Status

Akademiska University Hospital

Uppsala, , Sweden

Site Status

Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status

Beatson Oncology Centre

Glasgow, , United Kingdom

Site Status

St. James's University Hospital

Leeds, , United Kingdom

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Hammersmith Hospital

London, , United Kingdom

Site Status

Mount Vernon Hospital

Middlesex, , United Kingdom

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Newcastle General Hospital

Newcastle upon Tyne, , United Kingdom

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Northampton General Hosptial

Northampton, , United Kingdom

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Nottingham City Hospital

Nottingham, , United Kingdom

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Oxford Cancer Centre, Churchill Hospital

Oxford, , United Kingdom

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Scunthorpe General Hospital

Scunthorpe, , United Kingdom

Site Status

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Site Status

Glan Clwyd Hospital

Wales, , United Kingdom

Site Status

Countries

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Denmark United States Belgium Canada France Germany Netherlands Sweden United Kingdom

References

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Vuky J, Corman JM, Porter C, Olgac S, Auerbach E, Dahl K. Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer. Oncologist. 2013 Jun;18(6):687-8. doi: 10.1634/theoncologist.2011-0234. Epub 2013 Jun 5.

Reference Type DERIVED
PMID: 23740935 (View on PubMed)

Other Identifiers

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(VITAL-1)

Identifier Type: -

Identifier Source: secondary_id

G-0029

Identifier Type: -

Identifier Source: org_study_id