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