ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION
- Determine whether any intermediate endpoint biomarkers in patients at high risk for the
development of lung cancer change after treatment with isotretinoin given with or
without vitamin E.
- Determine whether vitamin E can reduce the toxic effects of low-dose isotretinoin
administered for 1 year in these patients.
OUTLINE: This is a randomized, double-blind study. Patients are stratified according to
smoking status (smoker vs ex-smoker).
All patients undergo bronchoscopy. All observed lesions are biopsied. Patients are then
randomized to one of three treatment arms.
- Arm I: Patients receive oral isotretinoin daily.
- Arm II: Patients receive oral isotretinoin and oral vitamin E daily.
- Arm III: Patients undergo observation only. Treatment continues in arms I and II for 1
year in the absence of unacceptable toxicity.
Patients are followed annually for 2 years.
PROJECTED ACCRUAL: A total of 60 patients (20 per arm) will be accrued for this study within
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Karen Kelly, MD
University of Colorado, Denver
United States: Federal Government
|University of Colorado Cancer Center at University of Colorado Health Sciences Center
|Denver, Colorado 80010
|Veterans Affairs Medical Center - Denver
|Denver, Colorado 80220
|Lung Cancer Institute
|Denver, Colorado 80218
|National Jewish Center for Immunology and Respiratory Medicine
|Denver, Colorado 80206