13-Cis Retinoic Acid With or Without Vitamin E for Prevention of Lung Cancer (13-Cis)
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|ClinicalTrials.gov Identifier: NCT00002586|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 7, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Drug Toxicity Lung Cancer||Drug: 13-cis retinoic acid Dietary Supplement: Tocopherol||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION|
|Study Start Date :||January 1993|
|Primary Completion Date :||December 2005|
|Study Completion Date :||December 2005|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|