Phase II Study of DCA (dichloracetate) vs. placebo in Combination with Cisplatin and Definitive Radiation in Stage III-IV Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to evaluate the safety and effectiveness of giving an investigational study medication, DCA (Dichloroacetate), to patients who have been diagnosed with squamous cell head and neck cancer (SCCHN) that is either recurrent (cancer that comes back) or newly diagnosed advanced (stage 3 or stage 4). The recommended treatment would be concurrent (at the same time) with Cisplatin (chemotherapy) and radiation treatment. Early stage of this disease (Stage 1 or 2) can be cured with surgery and/or radiation alone. Most of the squamous cell carcinoma of the head and neck cases are made up of Stage 3 and 4 of the disease and have been treated with radiation and in some cases surgery. We want to determine if adding the study drug, DCA, will improve overall survival. Effectiveness of treatment will be measured in terms of overall survival, time without evidence of cancer growth, and shrinkage of the tumor for those participants who have tumors that can be visualized by scans. In addition to studying the safety and effectiveness of DCA, researchers would also like to look at patient¿s HPV status (immune response). HPV, also known as Human Papilloma Virus, can cause infections in humans and in some caes are present in those with head and neck cancer. This information may allow us to find out if HPV status, positive or negative, can predict a response to therapy with DCA.
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