Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

NCT01163487 | Completed Phase 1 DMC

• 3 other identifiers: IRB-18245SU-05052010-5866ENT0031
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Head and Neck Cancers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Dichloroacetate (DCA)

EXPERIMENTAL

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

Drug: Dichloroacetate; Device: EF5

Interventions

Dichloroacetate DRUG

25-50mg/kg per day; oral

Also known as: DCA

Dichloroacetate (DCA)

EF5 DEVICE

21 mg/kg; IV

Also known as: EF-5

Dichloroacetate (DCA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daniel T. Chang: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Dichloroacetic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Chloroacetates; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Daniel T Chang

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Radiation Oncology

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 15, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2016
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

US (1)