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Home > "I" Clinical Trials Conditions > Isotretinoin With or Without Vitamin E for Prevention of Lung Cancer  Isotretinoin With or Without Vitamin E for Prevention of Lung Cancer
Isotretinoin With or Without Vitamin E for Prevention of Lung Cancer
For Condition: Non-small cell lung cancer,Small Cell Lung Cancer,Drug Toxicity
Status: No longer recruiting
Sponsor(s): University of Colorado Cancer Center ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KarenKelly, Study Chair, University of Colorado Cancer Center
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010
United States
National Jewish Center for Immunology and Respiratory Medicine
Denver, Colorado, 80206
United States
Lung Cancer Institute
Denver, Colorado, 80218
United States
Additional Information:
Study ID Numbers: CDR0000063730; UCHSC-92382,NCI-V94-0506
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002586
Other Non-Small Cell Lung Cancer Studies:
1. A Study Of Oral GW572016 In Advanced Or Metastatic Non-Small Cell Lung Cancer
2. Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer
3. Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
4. Oltipraz in the Prevention of Lung Cancer in People Who Smoke
5. INS316 in Diagnosing Lung Cancer in Patients With Untreated Lung Cancer
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Isotretinoin With or Without Vitamin E for Prevention of Lung Cancer
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