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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00702923
• Other study ID #: CO07808
• Secondary ID: CO07808H-2008-00
• Status: Terminated
• Phase: Phase 1
• Start date: July 2008
• Est. completion date: March 2013

Study information

• Verified date: April 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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)
• 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)
• 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)
• 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)
• 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

Locations

Country	Name	City	State
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants Who Developed Cancer Antigen-specific Immune Responses		Up to 12 months after treatment with study agent
Secondary	The Number of Participants With an Increase in PSA Doubling Time		Up to 18 months after last dose of study agent
Secondary	Number of Participants With PSA Recurrence.	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.	one year

External Links

•   University of Wisconsin Carbone Cancer Center