RATIONALE: 13 Cis retinoic acid may prevent the development of cancer cells. PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of 13-cis retinoic acid with or without vitamin E for chemoprevention or observation of cancer in persons at high risk of developing lung cancer.
OBJECTIVES: * To determine if alpha tocopherol can reduce the toxicities of low dose 13-cis retinoic acid administered for one year. * To access the adequacy of the collected specimens for studies of intermediate endpoint markers. * to establish a depository of biologic specimens for future studies of new biomarkers. * Arm 1: Patients receive oral 13-cis retinoic acid daily. * Arm 2: Patients receive oral 13-cis retinoic acid and oral vitamin E daily. * Arm 3: 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 100 patients (33 Arm 1, 33 Arm 2, and 34 Arm 3) will be accrued for this study within 3 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
96
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States
National Jewish Center for Immunology and Respiratory Medicine
Denver, Colorado, United States
Lung Cancer Institute
Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
Treatment failure
Treatment "failure" defined as histologic progression (any increase in the maximum histologic score) or failure to return for follow-up bronchoscopy
Time frame: Three years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.