Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

Phase I Trial of 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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Head and Neck Cancers
• Intervention / Treatment: Drug: Dichloroacetate; Device: EF5

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dichloroacetate (DCA); 25 mg/kg/day, 37.5 mg/kg, or 50 mg/kg/day oral DCA.	Drug: Dichloroacetate; 25-50mg/kg per day; oral; Other Names: DCA; Device: EF5; 21 mg/kg; IV; Other Names: EF-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Daniel T. Chang

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): February 1, 2015
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: July 6, 2010
• First Submitted That Met QC Criteria: July 14, 2010
• First Posted (ESTIMATE): July 15, 2010

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: IRB-18245; SU-05052010-5866 (OTHER: Stanford University); ENT0031 (OTHER: OnCore)