Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

Phase 1

Completed

• Conditions: Head and Neck Cancer; Head and Neck Cancers
• Interventions: Drug: Dichloroacetate; Device: EF5

• Registration Number: NCT01163487
• Lead Sponsor: Daniel T. Chang

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Study Start: 2010-08
• Primary Completion: 2015-02
• Study Completion: 2016-02
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dichloroacetate (DCA)	EF5	25 mg/kg/day, 37.5 mg/kg, or 50 mg/kg/day oral DCA.
Dichloroacetate (DCA)	Dichloroacetate	25 mg/kg/day, 37.5 mg/kg, or 50 mg/kg/day oral DCA.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States