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

This study is currently recruiting participants.
Verified October 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Daniel T. Chang, Stanford University
ClinicalTrials.gov Identifier:
NCT01163487
First received: July 6, 2010
Last updated: October 19, 2013
Last verified: October 2013
  Purpose

To determine the maximum tolerated dose of DCA in patients with recurrent head and neck cancer who have failed first-line therapy.

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.


Condition Intervention Phase
Head and Neck Cancer
Head and Neck Cancers
Drug: Dichloroacetate
Device: EF5
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: August 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dichloroacetate (DCA)
25 mg/kg/day, 37.5 mg/kg, or 50 mg/kg/day oral DCA.
Drug: Dichloroacetate
25-50mg/kg per day; oral
Other Name: DCA
Device: EF5
21 mg/kg; IV
Other Name: EF-5

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163487

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Cato Chan, B.S.    650-724-4606    catochan@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Daniel T Chang         
Sub-Investigator: Dr Andrew Quon         
Sub-Investigator: Dr. Billy W. Loo Jr. M.D. Ph.D.         
Sub-Investigator: Quynh-Thu Le         
Sub-Investigator: Albert Koong         
Sub-Investigator: Kristin Jensen         
Sub-Investigator: Edward Graves         
Sub-Investigator: Amato J Giaccia         
Sub-Investigator: Nicholas C Denko         
Sub-Investigator: Dr. A. Dimitrios Colevas         
Sponsors and Collaborators
Daniel T. Chang
Investigators
Principal Investigator: Daniel T Chang Stanford University
  More Information

No publications provided

Responsible Party: Daniel T. Chang, Assistant Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT01163487     History of Changes
Other Study ID Numbers: ENT0031, SU-05052010-5866, 18245
Study First Received: July 6, 2010
Last Updated: October 19, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014