FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer

Inclusion Criteria

• •Patients must have histopathologically / cytologically confirmed diagnosis of head and neck squamous cell carcinoma
• •Sites of primary tumor allowed include the oral cavity and oropharynx only. Patients with recurrent disease that is amenable to surgery are eligible
• •Patients may have any stage cancer amenable to surgical resection
• •Patients must be able to provide an archival tissue specimen. Excisional biopsy or core needle biopsy specimens are allowed. Fine needle aspiration samples are not acceptable
• •Patients with oropharynx cancer must have p16 negative disease
• •Age ≥ 18 years
• •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• •Leukocytes ≥ 3,000/mcL
• •Absolute neutrophil count ≥ 1,500/mcL
• •Platelets ≥ 100,000/mcl
• •Hemoglobin ≥ 9 g/dl
• •Total bilirubin ≤ 1.5 X institutional upper limit of normal
• •Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 X institutional upper limit of normal
• •Creatinine ≤ 1.5 X institutional upper limit of normal
• •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• •* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• •* Has not undergone a hysterectomy or bilateral oophorectomy; or
• •* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• •Ability to understand and the willingness to sign a written informed consent