Pilot Study of the Relationship Between EF5 Uptake and Concentration of Oxygen-Related Metabolites in Head and Neck Cancer
18 Years
N/A
Both
Head and Neck Cancer
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 Center | Durham, North Carolina 27710 |
