Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers
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ClinicalTrials.gov Identifier: NCT01163487 |
Recruitment Status :
Completed
First Posted : July 15, 2010
Last Update Posted : June 16, 2022
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Condition or disease | Intervention/treatment | Phase |
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Head and Neck Cancer Head and Neck Cancers | Drug: Dichloroacetate Device: EF5 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | February 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Dichloroacetate (DCA)
25 mg/kg/day, 37.5 mg/kg, or 50 mg/kg/day oral DCA.
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Drug: Dichloroacetate
25-50mg/kg per day; oral
Other Name: DCA Device: EF5 21 mg/kg; IV
Other Name: EF-5 |
- 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163487
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Daniel T Chang | Stanford University |
Documents provided by Daniel T. Chang, Stanford University:
Responsible Party: | Daniel T. Chang, Assistant Professor of Radiation Oncology, Stanford University |
ClinicalTrials.gov Identifier: | NCT01163487 |
Other Study ID Numbers: |
IRB-18245 SU-05052010-5866 ( Other Identifier: Stanford University ) ENT0031 ( Other Identifier: OnCore ) |
First Posted: | July 15, 2010 Key Record Dates |
Last Update Posted: | June 16, 2022 |
Last Verified: | June 2022 |
Head and Neck Neoplasms Neoplasms by Site Neoplasms |