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Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers

Sponsor
Daniel T. Chang (Other)
Overall Status
Completed
CT.gov ID
NCT01163487
Collaborator
(none)
17
Enrollment
1
Location
1
Arm
66
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
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 :
Aug 1, 2010
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

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 Names:
  • DCA

    • Device: EF5
    21 mg/kg; IV
    Other Names:
  • EF-5

    		•

    Outcome Measures

    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. [Duration of study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Daniel T. Chang

    Investigators

    • Principal Investigator: Daniel T Chang, Stanford University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel T. Chang, Assistant Professor of Radiation Oncology, Stanford University
    ClinicalTrials.gov Identifier:
    NCT01163487
    Other Study ID Numbers:
    • IRB-18245
    • SU-05052010-5866
    • ENT0031
    First Posted:
    Jul 15, 2010
    Last Update Posted:
    Jun 16, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:
    Head and Neck Neoplasms

    Study Results

    No Results Posted as of Jun 16, 2022