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


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The purpose of this research is to determine the safety of CP-675,206 when delivered in combination with short-term androgen deprivation therapy in patients with PSA-recurrent non-metastatic prostate cancer.

Outcome Time Frame:

Up to 12 months after treatment with study agent

Safety Issue:

Yes

Principal Investigator

Douglas McNeel, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

H2008-0086

NCT ID:

NCT00702923

Start Date:

July 2008

Completion Date:

December 2011

Related Keywords:

  • Prostate Cancer
  • Stage D0 Prostate Cancer
  • Rising PSA
  • Casodex
  • Tremelimumab
  • Prostatic Neoplasms

Name

Location
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164