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
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 1/Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of adenocarcinoma prostate cancer
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Prostate cancer deemed to be unresponsive or refractory to hormone therapy
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An ECOG performance status of 0 or 1
Exclusion Criteria:
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Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
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Previous chemotherapy, biological or immunotherapy for cancer
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Previous gene therapy for cancer
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Significant cancer related pain
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Cell Genesys
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- G-9803