Perlmutter Cancer Center

The purpose of the trial is to determine the safety and tolerability of birinapant concurrent with intensity modulated re-irradiation therapy for patients who have Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC). Birinapant is a novel bivalent small molecule peptidomimetic of SMAC, shown to preferentially target cIAP1, relative to cIAP2 and XIAP. Birinapant demonstrated anti-tumor activity in preclinical models of hematological cancers and solid tumors including melanoma, colorectal, ovarian, and breast cancer. We want to know the chemistry of birinapant in combination with radiotherapy in blood samples. The study drug birinapant is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.