A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
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. Inositol may be effective in preventing the development of lung cancer in patients with bronchial epithelial dysplasia.
PURPOSE: This phase I trial is studying the side effects and best dose of inositol in preventing lung cancer in current or former smokers with bronchial epithelial dysplasia.
详细描述
OBJECTIVES:
- Determine the safety of inositol for the prevention of lung cancer in patients with bronchial epithelial dysplasia who are current or former smokers.
- Determine the potential efficacy of this drug in regression of existing dysplastic lesions or prevention of appearance of new dysplastic lesions in these patients.
- Determine whether intake of this drug can facilitate smoking cessation in patients who are current smokers.
OUTLINE: This is a dose-escalation study.
Patients receive oral inositol twice daily. Treatment continues for 1 or 3 months in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-12 patients receive escalating doses of inositol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 12 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of persistent bronchial dysplasia despite regular twice-daily treatment with inhaled budesonide for 6 or 12 months on protocol BCCA-CIC-98-37
- •Current or former smokers who have smoked at least 30 pack years
- •Sputum cells showing AIC atypia by computer-assisted image analysis
- •At least 2 abnormal sites on fluorescence bronchoscopy (red/green ratio at least 0.45) suspicious for bronchial dysplasia
- •At least 1 site confirmed by bronchial biopsy
- •Solitary dysplastic lesion allowed provided the diameter is greater than 1.5 mm
- •No invasive cancer on bronchoscopy or abnormal low-dose spiral CT scan suspicious for lung cancer
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Hematologic function normal
- •No bleeding disorder
- •Liver function normal
- •Liver enzymes no greater than upper limit of normal
- •Renal function normal
- •Cardiovascular
- •No unstable angina
- •No congestive heart failure
- •No acute or chronic respiratory failure
- •No acute bronchitis or pneumonia within the past month
- •Fasting glucose less than 144 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Willing to have a bronchoscopy
- •No schizophrenia
- •No bipolar disorder
- •No diabetes
- •No known reaction to topical xylocaine
- •No other medical condition that would jeopardize patient safety during study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy
- •No prior surgery for lung cancer
- •No concurrent lithium
排除标准
- 未提供