CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Bicalutamide and CP-675,206 (Tremelimumab); Bicalutamide, CP-675,206 (tremelimumab); Bicalutamide, CP-675,206 (Tremelimumab); Bicalutamide, CP-675,206 (Tremelimumab); Bicalutamide, CP-675,206
Intervention description: Dose level -1 :
Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 3 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7); Dose level 1:
Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 6 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7); Dose level 2:
Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 10 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7); Dose level 3:
Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 15 mg/kg I.V. over 1 hour, day 29 Cycle repeated once at month 3 (beginning day 85 +/- 7); Final Dose Level:
Bicalutamide 150 mg p.o. q.d. day 1-28, day 85-112
At month 9, if evidence of PSA progression:
Bicalutamide 150 mg p.o. q.d. day 1-28 CP-675,206 (MTD dose) I.V. over 1 hour, day 29
Intervention MeSH terms: Tremelimumab; Bicalutamide; Ipilimumab; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stage D0 Prostate Cancer; Rising PSA; Casodex; Tremelimumab

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) 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.