Trial Information
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
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
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-9802
NCT ID:
NCT00140387
Start Date:
May 1999
Completion Date:
March 2001
Related Keywords:
- Prostate Cancer
- Prostate
- Cancer
- GVAX
- Metastatic
- Vaccine
- Allogeneic cells
- Prostatic Neoplasms
