Clinical trial · Interventional
Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers
Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers
NCT01163487CI-TRIAL-00059165completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dichloroacetate | Drug | — | UNRESOLVED |
| EF5 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dichloroacetate (DCA)
- description
- 25 mg/kg/day, 37.5 mg/kg, or 50 mg/kg/day oral DCA.
- interventionNames
- Drug: Dichloroacetate
- Device: EF5
Primary outcomes (1)
- measure
- To determine the maximum tolerated dose of DCA in patients with recurrent head and neck cancer who have failed first-line therapy.
- timeFrame
- Duration of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.