Clinical Trial Details

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Study ID ENT0031
Investigator
Daniel T Chang,   Stanford University
Title Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers
Conditions Head and Neck Cancer
Head and Neck Cancers
Interventions Drug: Dichloroacetate
Device: EF5
Phase Phase 1
Purpose To determine the maximum tolerated dose of DCA in patients with recurrent head and neck cancer who have failed first-line therapy. 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.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Both
Accepts Healthy Volunteers:  No
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
Study Location
Stanford University School of Medicine
Stanford, California, 94305
Contact Cato Chan, B.S.
650-724-4606
catochan@stanford.edu
Information objtained from ClinicalTrials.gov, on 7/25/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163487


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