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

University of Minnesota (UMN)

Status

Completed

Conditions

Tobacco Use Disorder

Lung Cancer

Squamous Lung Dysplasia

Treatments

Drug: pharmacological study

Drug: laboratory biomarker analysis

Drug: deuterated phenanthrene tetraol

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT01673711

2011NTUC092

NCI-2012-01148 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

350 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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