Trial Search Results

Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

The purpose of this study is to study the effect of the drug DCA (dichloroacetate) on recurrent head and neck cancers. Part of this study will also use EF5 PET scan to study tumor hypoxia.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Daniel T. Chang

Intervention(s):

  • Drug: Dichloroacetate
  • Device: EF5

Phase:

Phase 1

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
ccto-office@stanford.edu
650-498-7061
Not Recruiting