ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION
18 Years
N/A
Both
Drug/Agent Toxicity by Tissue/Organ, Lung Cancer
Trial Information
ASSESSMENT OF INTERMEDIATE ENDPOINT BIOMARKERS TO 13-CIS RETINOIC ACID WITH OR WITHOUT ALPHA TOCOPHEROL OR OBSERVATION
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Principal Investigator
Karen Kelly, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Colorado, Denver
Authority:
United States: Federal Government
Study ID:
CDR0000063730
NCT ID:
NCT00002586
Start Date:
January 1993
Completion Date:
Related Keywords:
- Drug/Agent Toxicity by Tissue/Organ
- Lung Cancer
- non-small cell lung cancer
- small cell lung cancer
- drug/agent toxicity by tissue/organ
- Lung Neoplasms
Name | Location |
|---|---|
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
| Lung Cancer Institute | Denver, Colorado 80218 |
| National Jewish Center for Immunology and Respiratory Medicine | Denver, Colorado 80206 |
