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Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

Primary Purpose

Head and Neck Cancer, Head and Neck Cancers

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dichloroacetate
EF5
Sponsored by
Daniel T. Chang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dichloroacetate (DCA)

Arm Description

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

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2010
Last Updated
June 13, 2022
Sponsor
Daniel T. Chang
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1. Study Identification

Unique Protocol Identification Number
NCT01163487
Brief Title
Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers
Official Title
Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel T. Chang

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Head and Neck Cancers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dichloroacetate (DCA)
Arm Type
Experimental
Arm Description
25 mg/kg/day, 37.5 mg/kg, or 50 mg/kg/day oral DCA.
Intervention Type
Drug
Intervention Name(s)
Dichloroacetate
Other Intervention Name(s)
DCA
Intervention Description
25-50mg/kg per day; oral
Intervention Type
Device
Intervention Name(s)
EF5
Other Intervention Name(s)
EF-5
Intervention Description
21 mg/kg; IV
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel T Chang
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

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