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Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00140348
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : December 24, 2007
Sponsor:
Information provided by:
Cell Genesys

Study Description
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Brief Summary:
The purpose of this study is to evaluate clinical and laboratory safety in patients receiving 4 different doses of GVAX® Prostate Cancer Vaccine in order to determine a maximum tolerated dose.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine in Patients With Metastatic Hormone-Refractory Prostate Cancer
Study Start Date : December 2001
Actual Study Completion Date : April 2005

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of adenocarcinoma of the prostate
  • Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
  • Detectable metastases
  • ECOG performance status of 0 or 1

Exclusion Criteria:

  • Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
  • Significant cancer related pain
  • Prior gene therapy, chemotherapy, or immunotherapy
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140348


Locations
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United States, California
South Orange County Medical Research Center
Laguna Woods, California, United States, 92637
UCSF
San Francisco, California, United States, 94115
West Coast Clinical Research
Tarzana, California, United States, 91356
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Northeast Indiana Research
Fort Wayne, Indiana, United States, 46825
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, Pennsylvania
Fox Chase cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Urology San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
Virginia Mason Med. Crt.
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Cell Genesys
More Information
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ClinicalTrials.gov Identifier: NCT00140348    
Other Study ID Numbers: G-0010
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: December 24, 2007
Last Verified: December 2007
Keywords provided by Cell Genesys:
Prostate
Cancer
Advanced Prostate Cancer
Metastatic
 Hormone-refractory
GVAX
Vaccine
Allogeneic cells
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases