Status:
COMPLETED
Two-Arm Study of a DNA Vaccine Encoding Prostatic Acid Phosphatase (PAP) in Patients With Non-Metastatic Castrate-Resistant Prostate Cancer
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The investigators are trying to find new methods to treat prostate cancer. The approach is to try to enhance patients' own immune response against the cancer. In this study, the investigators will be ...
Eligibility Criteria
Inclusion
- Diagnosis of Prostate Cancer
- Castrate Resistant Disease with rising PSA despite continuous treatment with orchiectomy or a LHRH agonist
- Rising PSA after treatment and withdrawal of anti-androgen
- Serum Testosterone \<50ng/mL
- Normal organ function per laboratory tests
Exclusion
- No evidence of immunosuppression or on treatment with immunosuppressive agents
- Cannot have discontinued LHRH agonist treatment (if not previously treated by orchiectomy) within 6 months prior to study entry
- Must not be concurrently taking other medications or supplements with known hormonal effects (other than the LHRH agonist noted above).
- Cannot have any evidence for metastatic disease on bone or CT scan
- Unable or unwilling to undergo two leukapheresis procedure
Key Trial Info
Start Date :
March 16 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00849121
Start Date
March 16 2009
End Date
February 17 2014
Last Update
November 21 2019
Active Locations (1)
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1
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792