CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
Stopped early · Phase 1
Conditions studied: Prostate Cancer
In brief
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) prostate cancer. This is a dose escalation study with safety the primary endpoint. Secondary endpoints will be to determine whether prostate associated immune responses are seen, and whether treatment is associated with an increase in PSA doubling time and PSA recurrence at one year, as markers of clinical activity. Cohorts of six patients will be treated in each dose level. The investigators hypothesize that short-term androgen deprivation therapy will elicit prostate cancer-associated T-cell mediated tissue destruction that can be augmented with a monoclonal antibody blocking CTLA-4, and that this will have therapeutic benefit in patients with recurrent prostate cancer.
Key facts
- Study ID
- NCT00702923
- Run by
- University of Wisconsin, Madison
- People needed
- 12
- Starts
- 2008-07-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2019-11-21
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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