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CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
This study is currently recruiting participants.
Verified by University of Wisconsin, Madison, April 2009
First Received: June 18, 2008   Last Updated: April 13, 2009   History of Changes
Sponsors and Collaborators: University of Wisconsin, Madison
Pfizer
Information provided by: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00702923
  Purpose

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.


Condition Intervention Phase
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

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Bicalutamide
U.S. FDA Resources
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

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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. [ Time Frame: Up to 12 months after treatment with study agent ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine whether prostate associated immune responses are elicited and whether treatment is associated with an increase in PSA doubling time and PSA recurrence at one year. [ Time Frame: Up to 12 months after last dose of study agent ] [ Designated as safety issue: No ]

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
1: Experimental
Bicalutamide 150mg orally days 1-28 followed by CP-675,206 IV on day 29. Cycle is repeated once at month 3
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)

Drug: Bicalutamide, CP-675,206 (tremelimumab)

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)

Drug: Bicalutamide, CP-675,206 (Tremelimumab)

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)

Drug: Bicalutamide, CP-675,206 (Tremelimumab)

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)

Drug: Bicalutamide, CP-675,206

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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702923

Contacts
Contact: Cancer Connect Clinical Trials Office 1-800-622-8922

Locations
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            
Sponsors and Collaborators
University of Wisconsin, Madison
Pfizer
Investigators
Principal Investigator: Douglas McNeel, MD, PhD University of Wisconsin, Madison
Principal Investigator: Douglas McNeel, M.D., PhD University of Wisconsin, Madison
  More Information

No publications provided

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: April 13, 2009
ClinicalTrials.gov Identifier: NCT00702923     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
Stage D0 Prostate Cancer
Rising PSA
Casodex
Tremelimumab

Study placed in the following topic categories:
Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones
Cytotoxic T-lymphocyte antigen 4
 Antibodies, Monoclonal
Antibodies
Androgen Antagonists
Bicalutamide
Prostatic Neoplasms
Immunoglobulins
Androgens

Additional relevant MeSH terms:
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
 Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009



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