NCT00140387
Completed
Phase 1
Phase I/II Study of a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®) in Hormone-naïve Prostate Cancer Patients
Cell Genesys0 sites20 target enrollmentMay 1999
ConditionsProstate Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Cell Genesys
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 20 years ago
Overview
Brief Summary
The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Cell Vaccines (Allogeneic Prostate GVAX®). Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of Allogeneic Prostate GVAX® on serum PSA levels will be evaluated and antitumor responses will be quantitated.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of adenocarcinoma prostate cancer
- •No evidence of measurable metastatic disease
- •An ECOG performance status of 0 or 1
Exclusion Criteria
- •Previous hormonal therapy of any type for prostate cancer
- •Any previous chemotherapy, or prior investigational therapy for prostate cancer
- •Prior Immunotherapy
- •Prior treatment with gene therapy
Outcomes
Primary Outcomes
Not specified
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