NCT00049140

EF5 Compared With Other Methods of Detecting Oxygen Levels in Tumor Cells of Patients With Head and Neck Cancer

Pilot Study of the Relationship Between EF5 Uptake and Concentration of Oxygen-Related Metabolites in Head and Neck Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: David M. Brizel, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors. PURPOSE: Phase II trial to compare diagnostic procedures using EF5 to that of other methods of detecting oxygen levels in tumor cells of patients who have head and neck cancer.

Detailed description

OBJECTIVES: * Determine the distribution, degree, and intrapatient and interpatient heterogeneity of hypoxia, as measured by EF5 binding in tumor tissue, in patients with head and neck cancer. * Determine the distribution and intrapatient and interpatient heterogeneity of CA9 expression, as measured immunohistochemically, in these patients. * Determine the distribution, concentration, and intrapatient and interpatient heterogeneity of glucose and lactate, as measured by bioluminescence imaging, in these patients. * Determine whether there is spatial coordination between concentrations of lactate and glucose and the location of tissue hypoxia in these patients. * Determine whether there is spatial coordination between the location of CA9 with hypoxia and/or lactate concentrations in these patients. OUTLINE: Patients receive EF5 IV over 1-2.5 hours on day 1. Within 24-55 hours after EF5 infusion, patients undergo surgery. Tumor tissue samples are examined for EF5 binding by immunohistochemistry, bioluminescence imaging, and flow cytometry. Patients are followed at 1 month and then for survival. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 1 year.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	EF5
OTHER	bioluminescence
OTHER	flow cytometry
OTHER	immunohistochemistry staining method
PROCEDURE	biopsy

Timeline

• Start date: 2002-08-01
• Primary completion: 2004-10-01
• First posted: 2003-01-27
• Last updated: 2014-07-25

Locations

1 site across 1 country: United States