Vaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for Prostate Cancer)

Phase I/II Study of Vaccination Priming and Vaccine Boosting With Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines in Patients With Prostate Cancer

The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with GVAX® Vaccine for Prostate Cancer. Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer on serum PSA levels, will be evaluated and antitumor responses will be quantitated.

Inclusion Criteria:

• Diagnosis of adenocarcinoma prostate cancer that has recurred after surgery by PSA
• No evidence of measurable metastatic disease
• An ECOG performance status of 0 or 1

Exclusion Criteria:

• Transitional cell, small cell or squamous cell prostate carcinomas
• Any previous radiation therapy, prior anti-androgens or prior investigational therapy
• Previous hormonal therapy of any type for prostate cancer
• Previous biological therapy for cancer