Spots Global Cancer Trial Database for 13-Cis Retinoic Acid With or Without Vitamin E for Prevention of Lung Cancer

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Trial Identification

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

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

Study ID: NCT00002586

Conditions

Drug Toxicity

Lung Cancer

Interventions

13-cis retinoic acid

Tocopherol

Study Description

Brief 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.