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

NCT ID: NCT00702923

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2013-03-31

Brief 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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Bicalutamide and CP-675,206 (Tremelimumab)

Intervention Type: DRUG

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)

Intervention Type: DRUG

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)

Intervention Type: DRUG

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)

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Casodex; Tremelimumab; Casodex; Tremelimumab; Casodex; Tremelimumab; Casodex; Tremelimumab; Casodex; Tremelimumab

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas McNeel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, United States

Countries

United States

Related Links

https://cancer.wisc.edu/

University of Wisconsin Carbone Cancer Center

Other Identifiers

CO07808

Identifier Type: -

Identifier Source: secondary_id

H-2008-0086

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-00713

Identifier Type: REGISTRY

Identifier Source: secondary_id

A534260

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/MEDICINE*H

Identifier Type: OTHER

Identifier Source: secondary_id

CO07808

Identifier Type: -

Identifier Source: org_study_id