Dose Escalation and Efficacy Trial of GVAX® Prostate Cancer Vaccine

Completed · Phase 1/Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00140348

Run by

Cell Genesys

People needed

80

Starts

2001-12-01

Expected to finish

2005-04-01

Last updated by the study team

2007-12-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
• Significant cancer related pain
• Prior gene therapy, chemotherapy, or immunotherapy

Where it is running

• South Orange County Medical Research Center — Laguna Woods, California, United States
• UCSF — San Francisco, California, United States
• West Coast Clinical Research — Tarzana, California, United States
• South Florida Medical Research — Aventura, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Carle Cancer Center — Urbana, Illinois, United States
• Northeast Indiana Research — Fort Wayne, Indiana, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Fox Chase cancer Center — Philadelphia, Pennsylvania, United States
• Urology San Antonio — San Antonio, Texas, United States
• Virginia Mason Med. Crt. — Seattle, Washington, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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