Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

Daniel T. Chang

Status and phase: Completed; Phase 1

Conditions: Head and Neck Cancers; Head and Neck Cancer

Treatments: Device: EF5; Drug: Dichloroacetate

Study type: Interventional

Funder types: Other

Identifiers

NCT01163487

SU-05052010-5866 (Other Identifier)

ENT0031

IRB-18245

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Dichloroacetate (DCA)

Experimental group

Description:

25 mg/kg/day, 37.5 mg/kg, or 50 mg/kg/day oral DCA.

Treatment:

Drug: Dichloroacetate

Device: EF5