Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

Head and Neck Cancer Clinical Trial

Official title:

Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163487
• Other study ID #: IRB-18245
• Secondary ID: SU-05052010-5866
• Status: Completed
• Phase: Phase 1
• Start date: August 2010
• Est. completion date: February 2016

Study information

• Verified date: June 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Cancers
• Head and Neck Neoplasms

Intervention

Drug:
• Dichloroacetate
25-50mg/kg per day; oral

Device:
• EF5
21 mg/kg; IV

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Daniel T. Chang

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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