The purpose of this study is to assess the activity of 5-azacitidine in patients with Human
Papilloma Virus (HPV)-positive and HPV- negative head and neck squamous cell carcinoma
(HNSCC). The response activity will be determined by analyzing your tumor tissue prior to and
after treatment with 5-azacitidine. Preliminary studies in mice bearing human head and neck
cancers or head and neck cancer cells cultured in laboratories suggest that treatment with
5-azacitidine increases changes in cancer cells that lead to their death. This study is
designed to determine if similar changes occur in cancer cells of patients with head and neck
cancer.
The study also aims to determine the amount of a specific type of protein, p53 before and
after treatment. Research has shown that the p53 protein is associated with anti-tumor
activity.
Finally, this study is measuring the amount of a specific type of protein called interferon
in your tumor tissue. Interferons are proteins made and released by the body in response to
pathogens (disease causing agents) such as viruses, bacteria, or tumor cells. Interferons
allow for communication between cells to trigger the protective defenses of the immune system
that remove pathogens (disease causing agents) or tumors.