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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Daniel T. Chang, Stanford University

ClinicalTrials.gov Identifier:

NCT01163487

First received: July 6, 2010

Last updated: June 22, 2016

Last verified: June 2016

History of Changes

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer Head and Neck Cancers	Drug: Dichloroacetate Device: EF5	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

Resource links provided by NLM:

MedlinePlus related topics: Head and Neck Cancer

U.S. FDA Resources

Further study details as provided by Daniel T. Chang, Stanford University:

Primary Outcome Measures:

To determine the maximum tolerated dose of DCA in patients with recurrent head and neck cancer who have failed first-line therapy. [ Time Frame: Duration of study ]


Enrollment:	17
Study Start Date:	August 2010
Study Completion Date:	February 2016
Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: DCA Device: EF5 21 mg/kg; IV Other Name: EF-5

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163487

Locations


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

Sponsors and Collaborators

Daniel T. Chang

Investigators


Principal Investigator:	Daniel T Chang	Stanford University

More Information


Responsible Party:	Daniel T. Chang, Assistant Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier:	NCT01163487 History of Changes
Other Study ID Numbers:	ENT0031 SU-05052010-5866 ( Other Identifier: Stanford University ) 18245 ( Other Identifier: Stanford IRB )
Study First Received:	July 6, 2010
Last Updated:	June 22, 2016

Additional relevant MeSH terms:


Head and Neck Neoplasms Neoplasms by Site Neoplasms

ClinicalTrials.gov processed this record on June 23, 2017

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