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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049140
• Other study ID #: CDR0000257828
• Secondary ID: DUMC-3512-02-3NC
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2002
• Last updated: July 24, 2014
• Start date: August 2002

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• EF5

Other:
• bioluminescence

• flow cytometry

• immunohistochemistry staining method

Procedure:
• biopsy

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
David M. Brizel, MD	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual		One Year	No
Primary	Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual		One year	No
Primary	Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual		One Year	No
Primary	Spatial coordination as measured by EF5 binding at completion of accrual		One Year	No
Primary	Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual		One year	No