This pilot phase II trial studies how well EF5 works in measuring lack of tumor oxygen, hypoxia, in patients with stage I-III non-small cell lung cancer. EF5 may be effective in measuring the lack of oxygen in lung tumors and may allow doctors to plan better treatment.
PRIMARY OBJECTIVES: I. Assess the frequency and degree of hypoxia as measured by EF5 binding in patients with non-small cell lung cancer. II. Correlate hypoxia as measured by EF5 binding with potential serum/plasma markers of hypoxia in patients with non-small cell lung cancer. III. Correlate hypoxia as measured by EF5 binding with tissue markers of hypoxia in patients with non-small cell lung cancer. IV. Correlate hypoxia as measured by EF5 binding with tumor angiogenesis in patients with non-small cell lung cancer. V. Correlated hypoxia as measured by EF5 binding with apoptosis in patients with non-small cell lung cancer. VI. Measure and characterize tumor perfusion in relationship to hypoxia in patients with non-small cell lung cancer. VII. Correlate tumor perfusion to microvessel density in tumor samples in patients with non-small cell lung cancer. VIII. Determine the longevity of EF5 adducts in human lung tumors. OUTLINE: Patients receive EF5 intravenously (IV) over 1-2.5 hours. Beginning 24-55 hours later, patients undergo tumor hypoxia measurement using a polarographic needle electrode and intraoperative tumor measurement before undergoing surgical biopsy or resection. After completion of study treatment, patients are followed up for 4-6 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Given IV
Correlative studies
Undergo surgery/thoracotomy
Undergo tumor hypoxia measurement
Durham Veterans Affairs Medical Center
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Frequency and degree of hypoxia using a polarographic needle electrode
Time frame: 55 hours post-EF5 infusion
Serum/plasma markers of hypoxia
Spearman's rank correlation will be used to examine the relationship between hypoxia as measured by EF5 binding with serum markers of hypoxia (vascular endothelial growth factor \[VEGF\], D-Dimer, plasminogen activator inhibitor type 1 \[PAI-1\]).
Time frame: 55 hours post-EF5 infusion
Tissue markers of hypoxia
Spearman's rank correlation will be used to examine the relationship between hypoxia as measured by EF5 binding with tissue markers of hypoxia (hypoxia inducible factor 1 \[HIF-1\] alpha, involucrin).
Time frame: 55 hours post-EF5 infusion
Tumor perfusion using dynamic positron emission tomography
Spearman's rank correlation will be used to examine the relationship between hypoxia as measured by EF5 binding with tumor perfusion.
Time frame: 10 days prior to surgery
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