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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David M. Brizel, MD, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00049140
First received: November 12, 2002
Last updated: July 24, 2014
Last verified: February 2013

November 12, 2002
July 24, 2014
August 2002
October 2004   (final data collection date for primary outcome measure)
  • Heterogeneity of hypoxia as measured by EF5 binding at completion of accrual [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Heterogeneity of CA9 expression by immunohistochemistry at completion of accrual [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Heterogeneity of glucose and lactate by bioluminescence imaging at completion of accrual [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Spatial coordination as measured by EF5 binding at completion of accrual [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Compare spatial coordination between the location of CA9 and hypoxia and/or lactate concentration at completion of accrual [ Time Frame: One year ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00049140 on ClinicalTrials.gov Archive Site
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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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Head and Neck Cancer
  • Drug: EF5
  • Other: bioluminescence
  • Other: flow cytometry
  • Other: immunohistochemistry staining method
  • Procedure: biopsy
Experimental: EF5
This is a non randomised single arm pilot study.
Interventions:
  • Drug: EF5
  • Other: bioluminescence
  • Other: flow cytometry
  • Other: immunohistochemistry staining method
  • Procedure: biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
Not Provided
October 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00049140
CDR0000257828, DUMC-3512-02-3, NCI-5929
Not Provided
David M. Brizel, MD, Duke University Medical Center
David M. Brizel, MD
National Cancer Institute (NCI)
Study Chair: David M. Brizel, MD Duke University
Duke University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP