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

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

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.

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.

• 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