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 1
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT00140400
- Lead Sponsor
- Cell Genesys
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method