Back to resultsEF5 in Measuring Tumor Hypoxia in Patients With Stage I-III Non-Small Cell Lung Cancer
Primary Purpose
Stage IA Non-Small Cell Lung Carcinoma, Stage IB Non-Small Cell Lung Carcinoma, Stage IIA Non-Small Cell Lung Carcinoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EF5
Laboratory Biomarker Analysis
Therapeutic Conventional Surgery
Tissue Oxygen Measurement
Sponsored by
About this trial
This is an interventional treatment trial for Stage IA Non-Small Cell Lung Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Known or suspected non-small cell lung cancer; patients without histologically or cytologically documented non-small cell lung cancer (NSCLC) must be estimated by their physician to have at least 75% probability of having NSCLC; the probability of malignancy will be predicted on the basis of known probabilities of individual clinical characteristics using a Bayesian model
- Clinical or pathologic stage I to III; patients in whom pre-surgical staging has not definitively establish stage IV disease are eligible
- Tumor mass at least 1.5 cm in maximum diameter must be present on computed tomography (CT) scan and must be included in the planned surgical biopsy or resection
- Patient must be planning to undergo a surgical staging or treatment procedure (including mediastinoscopy, wedge resection, lobectomy, or pneumonectomy) and have the clinical and physiological status appropriate for this procedure
- Performance status 0-2
- Bilirubin within normal limits
- Creatinine within normal limits or, if elevated, a creatinine clearance of at least 60 mL/min/m^2 (EF5 is primarily excreted via the kidney)
- White blood cell (WBC) > 2000/mm^3
- Platelets > 100,000/mm^3
Exclusion Criteria:
- Pregnancy or breast feeding; a negative serum pregnancy test is required of any woman of childbearing potential prior to enrollment; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with EF5
- Allergy to IV contrast dye
- History of grade III or IV peripheral neuropathy as defined by the National Cancer Institute (NCI) Common Terminology Criteria (CTC)
Sites / Locations
- Durham Veterans Affairs Medical Center
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (EF5)
Arm Description
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.
Outcomes
Primary Outcome Measures
Frequency and degree of hypoxia using a polarographic needle electrode
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]).
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).
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02154399
First Posted
May 30, 2014
Last Updated
April 10, 2015
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02154399
Brief Title
EF5 in Measuring Tumor Hypoxia in Patients With Stage I-III Non-Small Cell Lung Cancer
Official Title
Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IA Non-Small Cell Lung Carcinoma, Stage IB Non-Small Cell Lung Carcinoma, Stage IIA Non-Small Cell Lung Carcinoma, Stage IIB Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (EF5)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
EF5
Other Intervention Name(s)
EF-5
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo surgery/thoracotomy
Intervention Type
Other
Intervention Name(s)
Tissue Oxygen Measurement
Intervention Description
Undergo tumor hypoxia measurement
Primary Outcome Measure Information:
Title
Frequency and degree of hypoxia using a polarographic needle electrode
Time Frame
55 hours post-EF5 infusion
Title
Serum/plasma markers of hypoxia
Description
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
Title
Tissue markers of hypoxia
Description
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
Title
Tumor perfusion using dynamic positron emission tomography
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Known or suspected non-small cell lung cancer; patients without histologically or cytologically documented non-small cell lung cancer (NSCLC) must be estimated by their physician to have at least 75% probability of having NSCLC; the probability of malignancy will be predicted on the basis of known probabilities of individual clinical characteristics using a Bayesian model
Clinical or pathologic stage I to III; patients in whom pre-surgical staging has not definitively establish stage IV disease are eligible
Tumor mass at least 1.5 cm in maximum diameter must be present on computed tomography (CT) scan and must be included in the planned surgical biopsy or resection
Patient must be planning to undergo a surgical staging or treatment procedure (including mediastinoscopy, wedge resection, lobectomy, or pneumonectomy) and have the clinical and physiological status appropriate for this procedure
Performance status 0-2
Bilirubin within normal limits
Creatinine within normal limits or, if elevated, a creatinine clearance of at least 60 mL/min/m^2 (EF5 is primarily excreted via the kidney)
White blood cell (WBC) > 2000/mm^3
Platelets > 100,000/mm^3
Exclusion Criteria:
Pregnancy or breast feeding; a negative serum pregnancy test is required of any woman of childbearing potential prior to enrollment; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with EF5
Allergy to IV contrast dye
History of grade III or IV peripheral neuropathy as defined by the National Cancer Institute (NCI) Common Terminology Criteria (CTC)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kelley
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham Veterans Affairs Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
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EF5 in Measuring Tumor Hypoxia in Patients With Stage I-III Non-Small Cell Lung Cancer
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