Window Trial 5-aza in HNSCC, T-tare

NCT02178072 PHASE1 COMPLETED

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.

Details

Lead sponsor	Yale University
Phase	PHASE1
Status	COMPLETED
Enrolment	18
Start date	Thu Feb 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Oct 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

• 5-Azacitadine

Countries

United States