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CompletedNCT01163487Updated Jun 16, 2022

Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

A Phase 1 interventional study of Dichloroacetate and EF5 in Head and Neck Cancer and Head and Neck Cancers, sponsored by Daniel T. Chang. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-16.

Sponsored by Daniel T. Chang · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Head and Neck Cancer
  • Head and Neck Cancers
03

In context

Head and Neck Neoplasms

2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.

This study's enrollment of 17 is below the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

This is the only study on the registry with Daniel T. Chang as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Dichloroacetate (DCA)

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

    Drug: Dichloroacetate · Device: EF5

Interventions

  • DrugDichloroacetate

    25-50mg/kg per day; oral

    Also known as: DCA

  • DeviceEF5

    21 mg/kg; IV

    Also known as: EF-5

06

What researchers measure

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.

    Time frame: Duration of study

07

Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
08

References and documents

Study documents

  • Informed consent form · Jan 20, 2015

Documents are hosted by the registry — open the source record to download them.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2010, a primary completion of Feb 2015 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2010
First posted
Jul 15, 2010
Start
Aug 2010
Primary completionActual
Feb 2015
CompletionActual
Feb 2016
Last update
Jun 16, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01163487
Lead sponsor
Daniel T. Chang
Responsible party
Daniel T. Chang (Assistant Professor of Radiation Oncology, Stanford University) — Sponsor-investigator
First posted
Jul 15, 2010
Start date
Aug 2010
Primary completion
Feb 2015
Completion
Feb 2016
Last update
Jun 16, 2022

Study contacts

Daniel T Chang
principal investigator · Stanford University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dichloroacetic Acid

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