Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer

Study Overview
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Brief Summary
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This clinical trial studies deuterated phenanthrene tetraol in smokers who are at high risk for lung cancer. Studying samples of urine in the laboratory from smokers who are at high risk for lung cancer may help doctors learn more about biomarkers related to cancer.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine the relationship between urinary deuterated ([D10]) phenanthrene tetraol (PheT) level, PheT:phenanthrols (HOPhe) ratio, and the presence of bronchoepithelial metaplasia and/or dysplasia in smokers who have undergone screening bronchoscopy at Roswell Park Cancer Institute (RPCI). OUTLINE: Patients receive deuterated phenanthrene tetraol orally (PO). Urine samples are collected for laboratory studies for 6 hours after dosing.

Official Title
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Correlation of [D10] Phenanthrene Metabolism With Bronchoepithelial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer

Conditions
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Lung Cancer, Squamous Lung Dysplasia, Tobacco Use Disorder

Intervention / Treatment
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* Drug: deuterated phenanthrene tetraol
* Drug: pharmacological study
* Drug: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Current or former smoker 18 years of age or older Documentation of a diagnosis of no dysplasia, dysplasia, or metaplasia on bronchoscopy (white light and/or autofluorescence) conducted less than or equal to 10 years prior to registration Not pregnant or breastfeeding Able to provide written informed consent indicating an understanding of the nature of the study Willing to comply with study requirements, including taking [D10]phenanthrene in water with 20% ethanol No previous history of aerodigestive cancer Not currently undergoing treatment for any cancers. Exception: basal cell or squamous cell skin cancer Not currently taking any other investigational agents No history of allergic reaction to [D10]phenanthrene or similar compounds No major medical comorbidities, for example, renal dysfunction, heart function, and diabetes, to be adjudicated by study physicians Not a former or recovering alcoholic No use of metronidazole or antabuse less than or equal to 7 days prior to [D10]phenanthrene dosing, as they could potentially interact with ethanol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basic Science (deuterated phenanthrene tetraol)<br>Patients receive deuterated phenanthrene tetraol PO and collect urine for 6 hours after dosing. | Drug: deuterated phenanthrene tetraol<br>* Given PO<br>* Other names: phenanthrene-D10;Drug: pharmacological study<br>* Correlative studies<br>* Other names: pharmacological studies;Drug: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary deuterated phenanthrene tetraol level | A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of chronic obstructive pulmonary disease (COPD) or asbestos, duration of smoking, smoking intensity, age, and gender. | Up to 6 hours | 
| PheT:HOPhe ratio | A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender. | Up to 6 hours | 
| Correlation of deuterated phenanthrene tetraol level and PheT:HOPhe ratio with the presence of bronchoepithelial metaplasia and/or dysplasia | A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender. | Up to 6 hours |