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

Status:	Active, not recruiting
Conditions:	Lung Cancer, Cancer, Smoking Cessation, Tobacco Consumers
Therapuetic Areas:	Oncology, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	5/3/2018
Start Date:	July 2012
End Date:	December 2018

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

We found this trial at

sites

The Mayo Clinic

Rochester, Minnesota 55905

Principal Investigator: David E Midthun, MD

Phone: 507-538-1887

from

Rochester, MN