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

Who can take part

• 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

Who cannot take part

• Patients that have been previously treated with taxane chemotherapies
• Patients that have previously received radiation to the site of planned surgery
• Any diagnosis of immunodeficiency or patients receiving immunosuppressive therapy within 14 days of enrollment. Prednisone dose of ≤ 10mg is allowed
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to FID-007 or other agents used in study
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients with primary sites of the nasopharynx, salivary gland, or skin
• Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants