Vaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for Prostate Cancer)
Phase 1
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT00140374
- Lead Sponsor
- Cell Genesys
- Brief Summary
The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with GVAX® Vaccine for Prostate Cancer. Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer on serum PSA levels, will be evaluated and antitumor responses will be quantitated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
- Diagnosis of adenocarcinoma prostate cancer that has recurred after surgery by PSA
- No evidence of measurable metastatic disease
- An ECOG performance status of 0 or 1
Exclusion Criteria
- Transitional cell, small cell or squamous cell prostate carcinomas
- Any previous radiation therapy, prior anti-androgens or prior investigational therapy
- Previous hormonal therapy of any type for prostate cancer
- Previous biological therapy for cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method