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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Masonic Cancer Center, University of Minnesota
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01673711
First received: August 2, 2012
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Lung Cancer
Squamous Lung Dysplasia
Tobacco Use Disorder
Radiation: deuterated phenanthrene tetraol
Other: pharmacological study
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Correlation of [D10] Phenanthrene Metabolism With Bronchoepitheial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Urinary deuterated phenanthrene tetraol level [ Time Frame: Up to 6 hours ] [ Designated as safety issue: No ]
    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.

  • PheT:HOPhe ratio [ Time Frame: Up to 6 hours ] [ Designated as safety issue: No ]
    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.

  • Correlation of deuterated phenanthrene tetraol level and PheT:HOPhe ratio with the presence of bronchoepithelial metaplasia and/or dysplasia [ Time Frame: Up to 6 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 350
Study Start Date: July 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Basic Science (deuterated phenanthrene tetraol)
Patients receive deuterated phenanthrene tetraol PO. Urine samples are collected for laboratory studies for 6 hours after dosing.
Radiation: deuterated phenanthrene tetraol
Given PO
Other Names:
  • [D10] phenanthrene
  • phenanthrene-D10
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrolled in the High Risk Lung Cancer (HRLC) Screening Program
  • Eligible for bronchoscopy or have undergone screening bronchoscopy in the past
  • Current smoker of at least 10 cigarettes daily
  • Able to provide written consent indicating an understanding of the investigational nature of the study
  • Willing to take [D10]phenanthrene in water with 20% ethanol

Exclusion Criteria:

  • Previous aerodigestive tract cancer
  • Currently attempting to cut down or quit smoking
  • Major medical co-morbidities, for example, renal dysfunction, heart failure, and diabetes, to be adjudicated by study physicians
  • Pregnant women, women intending to become pregnant, or women who are breastfeeding
  • Former or recovering alcoholics
  • Those needing to take medications such as metronidazole, chlorpromazine, Antabuse or benzodiazepines within 7 days of the deuterated phenanthrene dosing, as they could potentially interact with ethanol; ineligibility based on use of other medications is at the discretion of the study physicians
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673711

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    AKSRPCI@roswellpark.org   
Principal Investigator: Alex A. Adjei         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Stephen S Hecht, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01673711     History of Changes
Other Study ID Numbers: 2011NTUC092, NCI-2012-01148
Study First Received: August 2, 2012
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Tobacco Use Disorder
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014