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Not Recruiting
Trial ID: NCT01163487
Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Professor of Radiation Oncology (Radiation Therapy)
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
drug: Dichloroacetate
device: EF5
Not Recruiting
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94305
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