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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
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Drug: EF5
Other: bioluminescence
Other: flow cytometry
Other: immunohistochemistry staining method
Procedure: biopsy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study of the Relationship Between EF5 Uptake and Concentration of Oxygen-Related Metabolites in Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: August 2002
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EF5
This is a non randomised single arm pilot study.
Drug: EF5 Other: bioluminescence Other: flow cytometry Other: immunohistochemistry staining method Procedure: biopsy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049140

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
David M. Brizel, MD
Investigators
Study Chair: David M. Brizel, MD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: David M. Brizel, MD, Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00049140     History of Changes
Other Study ID Numbers: CDR0000257828, DUMC-3512-02-3, NCI-5929
Study First Received: November 12, 2002
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
stage I squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage I squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the nasopharynx
stage I squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the nasopharynx
stage II squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
stage I salivary gland cancer
stage II salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
salivary gland squamous cell carcinoma

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 25, 2014