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Radiation-Induced Vaccination to Breast Cancer

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Technical Report,30 Sep 2014,29 Sep 2015

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University of California at Los Angeles Los Angeles United States

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This study combines the TGFbeta neutralizing antibody, Fresolimumab, with Radiation Therapy RT to treat advanced metastatic breast cancer. Since this drug has been discontunued, with DOD approval, in the near future we will be switching to the small molecule TGF-beta inhibitor, Galunisertib. This report deals with Fresolimumab,which was given 5 times as either 1 mgkg or 10 mgkg 3-weekly schedules. RT islimited to IGRT 3 x 7.5 Gy to 1-2 lesions with other lesions being designated assentinels to determine abscopal responses that are hypothesized to be due to RT induced vaccination. RT was started 10 days after the first and 3rd dose of Fresolimumab. The primary objectives are to assess safety, feasibility, and abscopal tumorregression and to monitor immune responses in these patients. The abscopal responses are assessed by imaging. The UCLA component is 3 fold 1 to enroll patients into the clinical trial, 2 to assess immune responses using blood samples before, during and after treatment by multi-channel flow cytometry for immunemonitoring, 3 to examine the effects of targeting TGF-beta on the activities and numbers of breast cancer stem cells with and without irradiation.

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