Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

Trial ID or NCT#

NCT01163487

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Quynh-Thu Le, MD
Quynh-Thu Le, MD
Radiation oncologist
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
Edward Graves
Kristin Jensen
Amato J. Giaccia
A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD
Medical oncologist, Head and neck specialist, Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Billy W Loo, Jr, MD PhD FASTRO FACR
Billy W Loo, Jr, MD PhD FASTRO FACR
Radiation oncologist, Thoracic specialist
Professor of Radiation Oncology (Radiation Therapy)

Contact us to find out if this trial is right for you.

Contact

ccto-office@stanford.edu
650-498-7061

View on ClinicalTrials.gov