NCT00056004已完成2 期
Phase II Trial Of Zileuton In Persons With Bronchial Dysplasia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Bronchial dysplasia number and grade at 6 months
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of zileuton may be an effective way to prevent lung cancer in patients who have bronchial dysplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of zileuton in preventing lung cancer in patients who have bronchial dysplasia.
详细描述
OBJECTIVES:
- Determine the efficacy of zileuton, in terms of number of sites and grade of dysplastic lesions in the bronchial epithelium, in patients with documented bronchial dysplasia.
- Correlate the regression of bronchial dysplasia (number and grade) and improvement in sputum cytology with the modulation of molecular biomarkers in patients treated with this drug.
- Determine the overall toxicity of this drug in these patients.
- Determine the 6-month natural history of bronchial dysplasia in patients who are randomized to receive treatment with a placebo.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to smoking status (current vs recently quit smoker), and prior cancer (none vs lung or head and neck). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral zileuton 4 times daily for 6 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral placebo 4 times daily for 6 months in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •At high risk for dysplasia, defined by 1 of the following criteria:
- •Current or former smokers who have smoked at least 30 pack-years
- •Former smokers must be enrolled within 20 years of complete smoking cessation
- •Patients with curatively treated stage I non-small cell lung cancer*
- •Patients with curatively treated stage I or II squamous cell carcinoma of the head and neck (limited to oral cavity, pharynx, or larynx)* NOTE: *At least 12 months post-curative therapy
- •Histologic confirmation of mild to severe bronchial dysplasia on bronchoscopic biopsy required
- •Moderate or severe atypia on sputum cytology required before bronchoscopy (not required for patients with prior lung or head and neck cancer)
- •No evidence of malignancy by chest x-ray
- •PATIENT CHARACTERISTICS:
- •18 and over (for patients with prior lung or head and neck malignancy)
- •35 and over (for all other patients)
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10.0 g/dL
- •No bleeding disorder
- •Bilirubin no greater than upper limit of normal (ULN)
- •Liver enzymes no greater than ULN
- •PT/PTT no greater than ULN
- •No active or chronic liver disease (even if transaminases have normalized)
- •Creatinine no greater than ULN
- •Cardiovascular
- •No unstable angina
- •No uncontrolled heart failure
- •No significant asthma or chronic obstructive pulmonary disease requiring chronic or periodic (at least once per year) steroids for flares
- •No acute or chronic respiratory failure
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Willing and able to undergo serial bronchoscopic examinations
- •No ongoing alcohol use (i.e., at least 1 glass of wine, beer, or a mixed drink per day on a regular basis)
- •No other medical condition that would preclude safety during study participation
- •No other active or invasive malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- •No hypersensitivity to study drug or any of its inactive ingredients
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •More than 3 months since prior corticosteroids*
- •No concurrent corticosteroids*
- •No concurrent anticancer hormonal agents NOTE: *Systemic or inhaled, including chronic administration
- •Radiotherapy
- •No concurrent radiotherapy
- •Not specified
- 另有 11 项未显示
排除标准
- 未提供
结局指标
主要结局
Bronchial dysplasia number and grade at 6 months
次要结局
- Biomarkers (Ki-67, Cyclin D1, bcl-2, bax, caspase-3) by immunohistochemistry at 6 and 12 months
- Biomarkers (5-HETE, LTB-4) by blood and BAL levels at 6 and 12 months
- Adverse events as measured by number and severity monthly
研究者
研究点 (2)
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