NCT00002586

13-Cis Retinoic Acid With or Without Vitamin E for Prevention of Lung Cancer

ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Drug Toxicity
• Lung Cancer

Interventions

Type	Name	Description
DRUG	13-cis retinoic acid
DIETARY_SUPPLEMENT	Tocopherol

Timeline

• Start date: 1993-01-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2003-01-27
• Last updated: 2020-05-15

Locations

4 sites across 1 country: United States