Status:
TERMINATED
CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Pfizer
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The current protocol will evaluate the safety of combining treatment with bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with PSA-recurrent non-metastatic (stage D0...
Detailed Description
This is an open label, single-center Phase I study. All subjects will receive bicalutamide 150mg orally days 1-28. Subjects will receive CP-675,206 IV over one hour on day 29. Doses will range from 6 ...
Eligibility Criteria
Inclusion
- At least 18 years of age \& histologic diagnosis of adenocarcinoma of the prostate
- Completed surgery or radiation at least 8 weeks prior to entry with removal of all visible disease
- Clinical Stage D0 prostate cancer with rising PSA and PSA \>2ng/ml.
- ECOG performance of \<2
- Normal hematologic, renal and liver function
Exclusion
- Cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy.
- No prior treatment with an LHRH agonist or nonsteroidal antiandrogen such as casodex or flutamide
- No evidence for metastatic disease per bone scan or CT scan of the abdomen and pelvis
- No prior treatment with anti-CTLA 4 monoclonal antibody
- No history of known autoimmune disorder or HIV, hepatitis B or hepatitis C
- No known brain metastases
- No history of inflammatory bowel conditions including diverticulitis, ulcerative colitis, etc.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00702923
Start Date
July 1 2008
End Date
March 1 2013
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