Safety Study of Radiation and CP-675,206 Infusion for Breast Cancer Patients
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.
Metastatic Breast Cancer
Radiation: External local radiation therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Local Radiation and CP-675,206 Administration in Patients With Inoperable Locally Recurrent or Metastatic Breast Cancer|
- Assessing safety through toxicities observed using CTCAE version 3.0 [ Time Frame: At each study visit for the duration of the 12-week cycle ] [ Designated as safety issue: Yes ]
- Evaluating lesions using Response Evaluation Criteria in Solid Tumors (RECIST 1.0) [ Time Frame: Every 8 weeks after treatment ] [ Designated as safety issue: Yes ]
- Immunological responses to the treatment measured through analysis of blood draws [ Time Frame: At the end of the 12-week cycle ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Experimental: Radiation combined with 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.Radiation: External local radiation therapy
One cycle of 2000cGy administered locally to one site over 5 days.
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.
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Srikala Sridhar, MD FRCPC||University Health Network - Princess Margaret Hospital|