Status:
UNKNOWN
GVAX in Advanced Prostate Cancer Patients Made Lymphopenic
Lead Sponsor:
Providence Health & Services
Collaborating Sponsors:
Providence Cancer Center, Earle A. Chiles Research Institute
Cell Genesys
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Androgen (a male sex hormone) deprivation is the standard therapy for metastatic prostate cancer and results in regression or control of disease in 80-85% of patients. This hormone therapy results in ...
Detailed Description
Other investigators have focused on tumor cell-based vaccine strategies using either allogeneic or autologous tumor cells. Vaccines derived from allogeneic melanoma tumor cell lines are associated wit...
Eligibility Criteria
Inclusion
- Histologically diagnosed adenocarcinoma of the prostate
- Progressive disease
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal and hepatic function
- Castrate levels of testosterone
- May have had local radiotherapy as part of their initial treatment or 28 days after palliative radiotherapy or one chemotherapy treatment for metastatic disease
Exclusion
- Transitional cell, small cell or squamous cell prostate cancer
- Systemic steroid therapy within 10-days of enrollment
- Documented history of active autoimmune disease such as lupus, sarcoidosis, rheumatoid arthritis, glomerulonephritis or vasculitis
- Clinically significant active infections
- History of other malignancies over past 5-years (except non-melanoma skin cancer or controlled superficial bladder cancer)
- Uncontrolled medical problems (i.e. neurological, cardiovascular) considered high risk for investigational new drug treatment
- Prior treatment with an investigational drug within 30-days of study entry
- Seropositive for HIV, hepatitis B surface antigen or hepatitis C
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2005
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00122005
Start Date
July 1 2005
End Date
July 1 2005
Last Update
February 24 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Providence Portland Medical Center
Portland, Oregon, United States, 97213