Phase I/II Study of a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Hormone-Refractory 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 a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Hormone-Refractory Prostate Cancer
Inclusion Criteria:
- Diagnosis of adenocarcinoma prostate cancer
- Prostate cancer deemed to be unresponsive or refractory to hormone therapy
- An ECOG performance status of 0 or 1
Exclusion Criteria:
- Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
- Previous chemotherapy, biological or immunotherapy for cancer
- Previous gene therapy for cancer
- Significant cancer related pain
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-9803
NCT ID:
NCT00140400
Start Date:
May 1999
Completion Date:
January 2001
Related Keywords:
- Prostate Cancer
- Prostate
- Cancer
- Advanced prostate cancer
- Metastatic
- Hormone-refractory
- GVAX
- Vaccine
- Allogeneic cells
- Prostatic Neoplasms
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