Phase I/II Study of Vaccination Priming and Vaccine Boosting With Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines in Patients With Prostate Cancer
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
Phase I/II Study of Vaccination Priming and Vaccine Boosting With Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines in Patients With Prostate Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
G-9705A
NCT ID:
NCT00140374
Start Date:
December 1998
Completion Date:
February 2001
Related Keywords:
- Prostate Cancer
- Prostate
- Cancer
- Vaccine
- GVAX
- Allogeneic cells
- Prostatic Neoplasms
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