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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01163487

Enrollment

Registered

2010-07-15

Start date

2010-08-31

Completion date

2016-02-29

Last updated

2022-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Head and Neck Cancers

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.

Interventions

DRUGDichloroacetate

25-50mg/kg per day; oral

DEVICEEF5

21 mg/kg; IV

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026