A Phase 2 interventional study of EF5 and Laboratory Biomarker Analysis in Stage IA Non-Small Cell Lung Carcinoma, Stage IB Non-Small Cell Lung Carcinoma and Stage IIA Non-Small Cell Lung Carcinoma, sponsored by National Cancer Institute (NCI). Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-13.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
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This study's enrollment of 28 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Exclusion Criteria:
Patients receive EF5 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.
Drug: EF5 · Other: Laboratory Biomarker Analysis · Procedure: Therapeutic Conventional Surgery · Other: Tissue Oxygen Measurement
Given IV
Also known as: EF-5
Correlative studies
Undergo surgery/thoracotomy
Undergo tumor hypoxia measurement
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
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)