Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel T. Chang, Stanford University
ClinicalTrials.gov Identifier:
NCT01163487
First received: July 6, 2010
Last updated: June 22, 2016
Last verified: June 2016
History of Changes
  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.

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

Study Type: Interventional
Study Design: 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:

U.S. FDA Resources

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 ]
Enrollment: 17
Study Start Date: August 2010
Study Completion Date: February 2016
Primary Completion Date: February 2015 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Daniel T. Chang
Investigators
Principal Investigator: Daniel T Chang Stanford University
  More Information

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: June 22, 2016
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 September 23, 2016