Status:
COMPLETED
Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine
Lead Sponsor:
Cell Genesys
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
- Significant cancer related pain
- Prior gene therapy, chemotherapy, or immunotherapy
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00140348
Start Date
December 1 2001
End Date
April 1 2005
Last Update
December 24 2007
Active Locations (12)
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1
South Orange County Medical Research Center
Laguna Woods, California, United States, 92637
2
UCSF
San Francisco, California, United States, 94115
3
West Coast Clinical Research
Tarzana, California, United States, 91356
4
South Florida Medical Research
Aventura, Florida, United States, 33180