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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01169 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2310 | Other Identifier | Duke University Medical Center | |
| 2310 | Other Identifier | CTEP | |
| P30CA014236 | U.S. NIH Grant/Contract | View source | |
| R21CA091565 | U.S. NIH Grant/Contract | View source |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (EF5) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EF5 | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and degree of hypoxia using a polarographic needle electrode | 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]). | 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). | 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. | 10 days prior to surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kelley | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham Veterans Affairs Medical Center | Durham | North Carolina | 27705 | United States | ||
| Duke University Medical Center |
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| Laboratory Biomarker Analysis |
| Other |
Correlative studies |
|
| Therapeutic Conventional Surgery | Procedure | Undergo surgery/thoracotomy |
|
| Tissue Oxygen Measurement | Other | Undergo tumor hypoxia measurement |
|
| Durham |
| North Carolina |
| 27710 |
| United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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