Isotretinoin With or Without Vitamin E for Prevention of Lung Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug/Agent Toxicity by Tissue/Organ; Lung Cancer
Intervention: isotretinoin (Drug); vitamin E (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of Colorado at Denver and Health Sciences Center Official(s) and/or principal investigator(s):
Karen Kelly, MD, Study Chair, Affiliation: University of Colorado at Denver and Health Sciences Center
Summary
RATIONALE: Isotretinoin may prevent the development of cancer cells.
PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of isotretinoin
with or without vitamin E for chemoprevention of cancer in persons at high risk of developing
lung cancer.
Clinical Details
Official title: ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION
Study design: Prevention, Randomized, Double-Blind, Active Control
Detailed description:
OBJECTIVES:
- 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.
- Determine whether vitamin E can reduce the toxic effects of low-dose isotretinoin
administered for 1 year in these patients.
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.
PROJECTED ACCRUAL: A total of 60 patients (20 per arm) will be accrued for this study within
3 years.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count greater than 1,500/mm^3
- Platelet count greater than 200,000/mm^3
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
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
Locations and Contacts
Lung Cancer Institute, Denver, Colorado 80218, United States
National Jewish Center for Immunology and Respiratory Medicine, Denver, Colorado 80206, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver, Colorado 80010, United States
Veterans Affairs Medical Center - Denver, Denver, Colorado 80220, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 1993
Last updated: June 17, 2008
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