13-Cis Retinoic Acid With or Without Vitamin E for Prevention of Lung Cancer (13-Cis)
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.
|Drug Toxicity Lung Cancer||Drug: 13-cis retinoic acid Dietary Supplement: Tocopherol||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
|Official Title:||ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION|
- Treatment failure [ Time Frame: Three years ]Treatment "failure" defined as histologic progression (any increase in the maximum histologic score) or failure to return for follow-up bronchoscopy
|Study Start Date:||January 1993|
|Study Completion Date:||December 2005|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
Experimental: 13-cis retinoic acid
13-cis retinoic acid 50 mg/d
Drug: 13-cis retinoic acid
Other Name: Isotretinoin, AccutaneT
Experimental: 13-Cis Retinoic Acid and Tocopherol
13-Cis Retinoic Acid (50 mg/day) Tocopherol (800 mg/day)
Drug: 13-cis retinoic acid
Other Name: Isotretinoin, AccutaneTDietary Supplement: Tocopherol
Other Name: Vitamin E
No Intervention: Observation
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002586
|United States, Colorado|
|University of Colorado Cancer Center at University of Colorado Health Sciences Center|
|Denver, Colorado, United States, 80010|
|National Jewish Center for Immunology and Respiratory Medicine|
|Denver, Colorado, United States, 80206|
|Lung Cancer Institute|
|Denver, Colorado, United States, 80218|
|Veterans Affairs Medical Center - Denver|
|Denver, Colorado, United States, 80220|
|Principal Investigator:||York E. Miller, MD||University of Colorado, Denver|