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

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ClinicalTrials.gov Identifier: NCT01163487
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Daniel T. Chang, Stanford University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Head and Neck Cancer Head and Neck Cancers Drug: Dichloroacetate Device: EF5 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers
Study Start Date : August 2010
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2016

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 ( Other Identifier: Stanford University )
18245 ( Other Identifier: Stanford IRB )
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016

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