NCT00140400
Completed
Phase 1
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
Cell Genesys0 sites50 target enrollmentMay 1999
ConditionsProstate Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Cell Genesys
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 20 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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