Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

NCT01163487 — Phase 1, Completed, 17 participants, Daniel T. Chang

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

Registry	NCT01163487
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	17 (Actual)
Sponsor	Daniel T. Chang (Other)
Conditions	Head and Neck Cancer, Head and Neck Cancers
Interventions	Dichloroacetate, EF5 (Drug, device)
Dates	start 2010-08-01, primary completion 2015-02-01, completion 2016-02-01, first posted 2010-07-15, last updated 2022-06-16
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Dichloroacetate (DCA)	Experimental	Drug: Dichloroacetate; Device: EF5	25 mg/kg/day, 37.5 mg/kg, or 50 mg/kg/day oral DCA.

Dichloroacetate (Drug), also known as DCA: 25-50mg/kg per day; oral
EF5 (Device), also known as EF-5: 21 mg/kg; IV

+Outcome measures

Primary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Stanford University School of Medicine	Stanford, California	United States

+Study documents

Informed Consent Form (PDF, 2015-01-20)

+Investigators

Daniel T Chang, Principal investigator, Stanford University