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Sponsors and Collaborators: |
University of Wisconsin, Madison Pfizer |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00702923 |
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. We 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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Bicalutamide and CP-675,206 (Tremelimumab) Drug: Bicalutamide, CP-675,206 (tremelimumab) Drug: Bicalutamide, CP-675,206 (Tremelimumab) Drug: Bicalutamide, CP-675,206 (Tremelimumab) Drug: Bicalutamide, CP-675,206 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Dose Escalation Trial of CP-675,206 (Tremelimumab, Anti-CTLA-4 Monoclonal Antibody) in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer |
Estimated Enrollment: | 24 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
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Drug: Bicalutamide and CP-675,206 (Tremelimumab)
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 |
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 mg/kg to 15 mg/kg. This cycle will be repeated once at month 3. Once the maximum tolerated dose has been determined, up to 6 additional subjects will be enrolled.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Douglas McNeel, MD | (608) 263-4198 | dm3@medicine.wisc.edu |
Contact: Mary J Staab, RN | (608) 263-7107 | mjs@medicine.wisc.edu |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: Doug 608-263-4198 dm3@medicine.wisc.edu | |
Contact: Mary J Staab (608) 263-7107 mjs@medicine.wisc.edu | |
Principal Investigator: Douglas McNeel |
Principal Investigator: | Douglas McNeel, MD, PhD | University of Wisconsin, Madison |
Principal Investigator: | Douglas McNeel, M.D., PhD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center ( Douglas McNeel, MD ) |
Study ID Numbers: | H2008-0086, CO07808 |
Study First Received: | June 18, 2008 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00702923 |
Health Authority: | United States: Food and Drug Administration |
Stage D0 Prostate Cancer Rising PSA Casodex Tremelimumab |
Antibodies, Monoclonal Antibodies Prostatic Diseases Genital Neoplasms, Male Bicalutamide |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Cytotoxic T-lymphocyte antigen 4 Immunoglobulins |
Androgen Antagonists Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses |
Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pharmacologic Actions |