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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Head and Neck Cancers

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Trial Information

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


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 >100,000/uL

- total bilirubin within 1.5X normal institutional limits

- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal

- creatinine within normal institutional limits

- creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above
institutional normal

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Duration of study

Safety Issue:

Yes

Principal Investigator

Daniel T Chang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

ENT0031

NCT ID:

NCT01163487

Start Date:

August 2010

Completion Date:

February 2014

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Cancers
  • Head and Neck Neoplasms

Name

Location
Stanford University School of Medicine Stanford, California  94305-5317