Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Isotretinoin With or Without Vitamin E for Prevention of Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Prevention, Supportive care Closed Over 18 Other UCHSC-92382 NCI-V94-0506, NCT00002586

Objectives

1. Determine whether any intermediate endpoint biomarkers in patients at high risk for the development of lung cancer change after treatment with isotretinoin given with or without vitamin E.
2. Determine whether vitamin E can reduce the toxic effects of low-dose isotretinoin administered for 1 year in these patients.

Entry Criteria

Disease Characteristics:

• Current smokers with at least a 40-pack/year history OR



• Former smokers considered at high risk for the development of lung cancer
  • At least a 40-pack/year history
  • No smoking in the past 12 months
  • At least 1 of the following high-risk conditions:
    • Mild, moderate, or severe dysplasia
    • Carcinoma in situ
    • Surgically cured head and neck cancer with at least mild atypia on staging bronchoscopy (includes carcinoma in situ)



• No pneumonia or acute bronchitis requiring antibiotics within past 2 months prior to entry



• No evidence of tumor on chest x-ray

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Other

• See Disease Characteristics
• No concurrent tetracycline or minocycline
• No concurrent vitamin supplements

Patient Characteristics:

Age:

• Over 18

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count greater than 1,500/mm³
• Platelet count greater than 200,000/mm³

Hepatic:

• Bilirubin less than 1.5 mg/dL
• ALT less than 4 times upper limit of normal
• No hypercholesterolemia/hypertriglyceridemia

Renal:

• Creatinine less than 1.5 mg/dL

Cardiovascular:

• No active atherosclerotic cardiovascular disease (angina, claudication)

Other:

• No other malignancy within past 5 years except surgically cured skin cancer or in situ cancer
• No insulin-dependent diabetes mellitus
• No history of abnormal bleeding
• No other serious concurrent illness
• No fertile women

Expected Enrollment

A total of 60 patients (20 per arm) will be accrued for this study within 3 years.

Outline

This is a randomized, double-blind study. Patients are stratified according to smoking status (smoker vs ex-smoker).

All patients undergo bronchoscopy. All observed lesions are biopsied. Patients are then randomized to one of three treatment arms.

• Arm I: Patients receive oral isotretinoin daily.



• Arm II: Patients receive oral isotretinoin and oral vitamin E daily.



• Arm III: 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.

Trial Contact Information

Trial Lead Organizations

University of Colorado Cancer Center at UC Health Sciences Center

Karen Kelly, MD, Protocol chair		Ph: 303-724-3903; 800-473-2288 Email: karen.kelly@uchsc.edu

Registry Information
Official Title		ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION
Trial Start Date		1993-01-16
Registered in ClinicalTrials.gov		NCT00002586
Date Submitted to PDQ		1993-01-16
Information Last Verified		2003-12-08
NCI Grant/Contract Number		P30-CA46934

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