Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

Study Overview
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Brief Summary
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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.

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

Conditions
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Head and Neck Cancer, Head and Neck Cancers

Intervention / Treatment
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* Drug: Dichloroacetate
* Device: EF5


Participation Criteria
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Eligibility Criteria
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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: Patients with documented tumors involving the liver who have Grade <2 elevations in AST, ALT, and/or alkaline phosphatase are eligible if <5X ULN. 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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dichloroacetate (DCA)<br>25 mg/kg/day, 37.5 mg/kg, or 50 mg/kg/day oral DCA. | Drug: Dichloroacetate<br>* 25-50mg/kg per day; oral<br>* Other names: DCA;Device: EF5<br>* 21 mg/kg; IV<br>* Other names: EF-5;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose of DCA in patients with recurrent head and neck cancer who have failed first-line therapy. |  | Duration of study |