Safety Study of Radiation and CP-675,206 Infusion for Breast Cancer Patients

NCT ID: NCT01334099

Last Updated: 2015-06-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31

Brief Summary

The purpose of this study is to determine the maximum dose of CP-675,206 when given in combination with radiation. Patients will be given local radiation to one tumor site and an intravenous infusion of CP-675,206.

Detailed Description

Breast cancer is the most common cancer in Canadian women. In 2007 an estimated 22,300 women will be diagnosed and 5300 will die of the disease. Despite advances in therapy, metastatic disease remains an incurable illness, with a median survival of only 2 years. Standard systemic treatment options for metastatic disease include chemotherapy or hormonal therapy. Radiation is frequently used in the metastatic setting for palliation of symptoms, with the most frequent site of radiation being bone. Response rates to first line chemotherapy are in the range of 30%, however these responses are not durable. Currently there are no curative options for metastatic disease, underscoring the need for novel therapeutic approaches.

CTLA4 is a receptor expressed on the surface of activated T cells and regulatory T cells. CTLA-blockade has been tested in clinical trials using humanized monoclonal antibodies, and some biological responses have been reported. The anti-tumor immune response may be further augmented by the combination of CTLA4-blockade with radiation, with the potential to mediate regression of metastases outside of the field of radiation. The primary goal of this study therefore is to establish the safety of CTLA4-blockade using the antibody CP-675, 206 in combination with radiation. This trial is being conducted as a prelude to a planned phase II trial of CP-675,206 in combination with radiation in metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Study Design

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

Study Groups

Radiation combined with CP-675,206

Group Type: EXPERIMENTAL

CP-675,206

Intervention Type: BIOLOGICAL

Intravenous infusion for one cycle (further cycles permitted as per medical assessment). Patient assigned dose of 3mg/kg, 6mg/kg, 10mg/kg, or 15mg/kg.

External local radiation therapy

Intervention Type: RADIATION

One cycle of 2000cGy administered locally to one site over 5 days.

Interventions

CP-675,206

Intravenous infusion for one cycle (further cycles permitted as per medical assessment). Patient assigned dose of 3mg/kg, 6mg/kg, 10mg/kg, or 15mg/kg.

Intervention Type: BIOLOGICAL

External local radiation therapy

One cycle of 2000cGy administered locally to one site over 5 days.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Inoperable locally recurrent or metastatic breast cancer
• Performance status 0-1
• Adequate organ function as determined by lab tests
• Greater than 3 weeks since any chemotherapy treatment
• Greater than 2 weeks since last dose of hormonal therapy

Exclusion Criteria

• Previous treatment with any anti-CTLA4 agent
• Patients with active diarrhea
• Patients who will receive radiation to pelvic lesions
• History of chronic inflammatory or autoimmune disorder
• History of insulin-dependent diabetes
• History in the last 5 years of any chronic gastrointestinal conditions
• History within the last year of congestive heart failure, stroke, myocardial infarction or thromboembolic event
• Patients with known brain metastasis
• Concurrent treatment with immunosuppressive medication for longer than 10 days within 4 weeks of enrollment or while on trial
• Patients of reproductive potential not using effective contraception, breast-feeding, or patients who test positive for pregnancy at enrollment

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

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Srikala Sridhar, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network - Princess Margaret Hospital

Locations

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

GA3671RD IIR#1

Identifier Type: -

Identifier Source: org_study_id