Trial Search Results
Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers
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.
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
Daniel T. Chang
Stanford Investigator(s):
Intervention(s):
- Drug: Dichloroacetate
- Device: EF5
Phase:
Phase 1
Eligibility
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
ccto-office@stanford.edu
650-498-7061
Not Recruiting