Skip to main content
OpenTrials
Completed

NCT Number: NCT00049140

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Salivary Gland Diseases Salivary Gland Neoplasms Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EF5

Drug

bioluminescence

Other

flow cytometry

Other

immunohistochemistry staining method

Other

Biopsy

Procedure

Primary outcomes

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

    Time frame: One Year

  2. Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual

    Time frame: One year

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

    Time frame: One Year

  4. Spatial coordination as measured by EF5 binding at completion of accrual

    Time frame: One Year

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

    Time frame: One year

Sponsors and collaborators

Lead sponsor

David M. Brizel, MD

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2004
First posted
Jan 27, 2003
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.