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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Pilot Study of the Relationship Between EF5 Uptake and Concentration of Oxygen-Related Metabolites in 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

One Year

Safety Issue:

No

Principal Investigator

David M. Brizel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000257828

NCT ID:

NCT00049140

Start Date:

August 2002

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Head and Neck Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710