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

NCT00702923 | Terminated Phase 1 Results DMC

• 5 other identifiers: CO07808H-2008-0086NCI-2011-00713A534260SMPH/MEDICINE/MEDICINE*H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Stage D0 Prostate Cancer; Rising PSA; Casodex; Tremelimumab

Outcome Measures

Primary Outcomes (1)

• The Number of Participants Who Developed Cancer Antigen-specific Immune Responses

  Up to 12 months after treatment with study agent

Secondary Outcomes (2)

• The Number of Participants With an Increase in PSA Doubling Time

  Up to 18 months after last dose of study agent

• Number of Participants With PSA Recurrence.

  one year

Study Arms (1)

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

Interventions

Bicalutamide and CP-675,206 (Tremelimumab) 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)

Also known as: Casodex, Tremelimumab

1

Bicalutamide, CP-675,206 (Tremelimumab) 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)

Also known as: Casodex, Tremelimumab

1

Bicalutamide, CP-675,206 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

Also known as: Casodex, Tremelimumab

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Pfizer: collaborator

Study Sites (1)

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; tremelimumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Douglas McNeel, M.D., Ph.D.
• Organization: University of Wisconsin Carbone Cancer Center

dm3@medicine.wisc.edu

(608) 263-4198

Study Officials

• Douglas McNeel, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 20, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: March 1, 2013
• Last Updated: November 21, 2019
• Results First Posted: May 7, 2014

Record last verified: 2014-04

Locations

US (1)