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

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: EF5; Other: bioluminescence; Other: flow cytometry; Other: immunohistochemistry staining method; Procedure: biopsy

• Registration Number: NCT00049140
• Lead Sponsor: David M. Brizel, MD

Brief 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.

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2002-11-12
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-10
• Status Verified: 2013-02
• Last Update Submitted: 2014-07-24
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EF5	biopsy	This is a non randomised single arm pilot study.
EF5	flow cytometry	This is a non randomised single arm pilot study.
EF5	immunohistochemistry staining method	This is a non randomised single arm pilot study.
EF5	bioluminescence	This is a non randomised single arm pilot study.
EF5	EF5	This is a non randomised single arm pilot study.

Primary Outcome Measures

Name	Time	Method
Spatial coordination as measured by EF5 binding at completion of accrual	One Year
Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual	One Year
Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual	One year
Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual	One Year
Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual	One year

Trial Locations

Locations (1)

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States