Prime-Boost Dose Scheduling Trial for Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Patients With Hormone-Refractory Prostate Cancer

Phase I/II Study of a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Hormone-Refractory Prostate Cancer

The objective of this study is to evaluate the safety and efficacy of a prime-boost dose schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) as measured by standard toxicity evaluation, changes in PSA, and tumor responses. Additional objectives are to measure the time to PSA and/or clinical disease progression as well as local and systemic immune responses to the vaccine.

Inclusion Criteria:

• Diagnosis of adenocarcinoma prostate cancer
• Prostate cancer deemed to be unresponsive or refractory to hormone therapy
• An ECOG performance status of 0 or 1

Exclusion Criteria:

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