CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer

This study has been terminated.
(Enrollment was halted prematurely due to slow accrual.)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00702923
First received: June 18, 2008
Last updated: April 7, 2014
Last verified: April 2014
  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 1

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The Number of Participants Who Developed Cancer Antigen-specific Immune Responses [ Time Frame: Up to 12 months after treatment with study agent ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The Number of Participants With an Increase in PSA Doubling Time [ Time Frame: Up to 18 months after last dose of study agent ] [ Designated as safety issue: No ]
  • Number of Participants With PSA Recurrence. [ Time Frame: one year ] [ Designated as safety issue: No ]
    PSA recurrence is defined as a minimum PSA value of greater or equal to 1.0ng/ml occurring within one year after the last treatment with CP-675,206, with a confirmatory PSA blood teat performed at least 2 weeks later.


Enrollment: 12
Study Start Date: July 2008
Study Completion Date: March 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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)

Other Names:
  • Casodex
  • Tremelimumab
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)

Other Names:
  • Casodex
  • Tremelimumab
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)

Other Names:
  • Casodex
  • Tremelimumab
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)

Other Names:
  • Casodex
  • Tremelimumab
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

Other Names:
  • Casodex
  • Tremelimumab

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702923

Locations
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
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, Madison
ClinicalTrials.gov Identifier: NCT00702923     History of Changes
Other Study ID Numbers: CO07808, CO07808
Study First Received: June 18, 2008
Results First Received: February 24, 2014
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 20, 2014