Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

Inclusion Criteria:

- Pathologically confirmed head and neck squamous cell carcinoma

- Age > 18 years old

- Patients must have unresectable disease in which there is no accepted potentially
curative treatment option

- Patients must have acceptable organ and marrow function as defined below:

- leukocytes >3,000/uL

- absolute neutrophil count >1,500/uL

- platelets >90,000/uL

- total bilirubin <=1.5X normal institutional limits

- AST(SGOT)/ALT(SGPT) <=2.5 X normal institutional limits with the following
exceptions:

1. Patients with documented tumors involving the liver who have Grade <2 elevations
in AST, ALT, and/or alkaline phosphatase are eligible if <5X ULN.

2. Patients with documented tumors involving bone who have a Grade <2 elevation in
alkaline phosphatase are eligible if <5X ULN.

- creatinine <=1.5X normal institutional limits OR creatinine clearance >50 mL/min on
the basis of the Cockcroft-Gault glomerular filtration rate estimation

- Patients must have non-cranial gross disease that is greater than 1 cm on CT scan
prior to enrollment

- Disease must be FDG-avid on PET scanning

- Creatinine within normal institutional limits

- Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix 1)

- Life expectancy > 12 weeks

- Both men and women and members of all races and ethnic groups are eligible for this
trial.

Exclusion Criteria:

- Women who are pregnant

- Administration of any systemic cytotoxic agents within the last 2 weeks of enrollment

- Patients who are unwilling or unable to provide informed consent

- Patients who have potentially curable disease

- Participation in another concurrent treatment protocol