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

David M. Brizel, MD8 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

EF5DRUG

bioluminescenceOTHER

flow cytometryOTHER

immunohistochemistry staining methodOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck * Clinically detectable disease by physical examination or radiographic studies * Scheduled to undergo surgical resection of tumor or radiotherapeutic treatment PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL Renal * Creatinine no greater than 1.8 mg/dL Other * No allergy to IV contrast dye * No prior grade III or IV peripheral neuropathy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 week after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * Concurrent radiotherapy allowed Surgery * See Disease Characteristics

Locations (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual

Time frame: One Year

Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual

Time frame: One year

Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual

Time frame: One Year

Spatial coordination as measured by EF5 binding at completion of accrual

Time frame: One Year

Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual

Time frame: One year

Data from ClinicalTrials.gov

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