Azacitidine in Measuring Tumor Response in Patients with HPV Positive or Negative Head and Neck Squamous Cell Carcinoma

Inclusion Criteria

• Patients must have histologically-confirmed HNSCC that is p16 or HPV PCR positive
• Patients must be agreeable to provide tissue prior to enrollment
• The patients must have no prior chemotherapy or radiation therapy as treatment for the observed HNSCC
• Eastern Co-operative Oncology Group (ECOG) performance status score of 0, 1, or 2
• Hemoglobin >= 8 g/dL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
• Creatinine within 1.5 x upper limit of normal (ULN) OR creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial; pregnant and nursing patients are excluded; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; if the pregnancy is found during the 5-azacitadine treatment, then the treatment will be immediately stopped; sexually active men must also use appropriate contraception method and should not father a child while receiving therapy during this study
• Must be able to understand and sign a written informed consent document

Exclusion Criteria

• Patients with known brain metastases
• Patients receiving any other investigational agents within 4 weeks of starting the study
• History of allergic reactions attributed to 5 azacitidine