NCT02794428已完成2 期
Targeted Chemoprevention of Gastric Carcinogenesis in High Risk Populations
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- The Difference in Cell DNA Damage, Based on Percent Positive Cells, Between Patients Treated With DFMO and Patients Treated With Placebo at 6 Months.
研究概览
简要总结
A clinical study of the efficacy of oral alpha-difluoromethylornithine (eflornithine or DFMO) in male and female subjects ages 30-60 with gastric premalignant lesions in two high risk regions of Latin America.
详细描述
Primary Objective
- The difference in cell DNA damage between patients treated with DFMO and patients treated with placebo at 6 months. The cell DNA damage is measured using the percent positive gastric epithelial cells assessed by IHC for gamma H2AX. The mean difference between the two groups at 6 months will be calculated, accounting for their baseline measurements.
Secondary Objectives
- The difference in cell DNA damage between patients treated with DFMO and patients treated with placebo for 18 months, and then followed for an additional 6 months. The cell DNA damage is measured using the percent positive gastric epithelial cells assessed by IHC for gamma H2AX. The mean difference between the two groups at 18 and 24 months will be calculated, accounting for their baseline measurements.
- The differences in the gastritis histopathology score between patients treated with DFMO and patients treated with placebo for a total of 18 months, and followed for an additional 6 months. The gastritis histopathology score is measured with a quantitative scale 0.0-6.0, for atrophy, intestinal metaplasia, and dysplasia. The mean differences between the two groups at 6, 18, and 24 months will be calculated using mixed models, accounting for their baseline measurements.
- Number of patients with quantitative toxicities. Toxicities will be assessed per CTCAE criteria, and each toxicity will be assigned an adverse event (AE) term according to CTCAE definitions (each AE term = unique representation of a specific event used for medical documentation and scientific analyses), and graded as defined by CTCAE (grade 1 = mild; grade 2 = moderate; grade 3 = severe or significant but not immediately life-threatening; grade 4 = life-threatening; grade 5 = death).
- To evaluate whether candidate single nucleotide polymorphisms (SNPs) relevant to eflornithine (DFMO) efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a history of a premalignant lesion of the stomach, atrophic gastritis or intestinal metaplasia
- •Patients must have a pure tone audiometry evaluation to document air conduction within 60 days prior to randomization.
- •Patients must have adequate blood counts as evidenced by the following results (obtained within 60 days):
- •Blood counts: WBC ≥4.0 /mcL, platelets ≥100,000 /mcL and hemoglobin ≥11.0 g/dL
- •Kidney function: Creatinine <1.6 x IULN (institutional upper limit of normal)
- •Liver function tests: Bilirubin ≤2.0 mg/dL and AST (SGOT) or ALT (SGPT) ≤2 x IULN
排除标准
- •Subjects with dysplasia (indeterminate, low grade, high grade) are not eligible for participation
- •Patients must not have a significant medical or psychiatric condition that would preclude study completion.
- •Patients with hearing loss ≥30 dB in any of the tested frequencies (250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 8,000 Hz) are not eligible.
- •Patients must not have known hypersensitivity to eflornithine or the excipients.
- •Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis.
- •Patients must not have a significant cardiovascular disease history, including uncontrolled blood pressure (sBP > 150 mmHg), myocardial infarction, cerebrovascular accident, or heart failure (New York Heart Association Class III, or IV).
- •Patients must not have a history of gastric or esophageal cancer, gastric resection or surgery, peptic ulcer disease (within 6 months), H. pylori treatment (within 6 months), or inflammatory bowel disease.
- •No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for >5 years.
- •Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis.
- •Patients must not be pregnant or nursing (due to eflornithine pregnancy class C). Women and men of reproductive potential must have agreed to use an effective contraceptive method.
研究组 & 干预措施
Eflornithine
Active Comparator
干预措施: Eflornithine (Drug)
Eflornithine Placebo
Placebo Comparator
干预措施: Eflornithine placebo (Other)
结局指标
主要结局
The Difference in Cell DNA Damage, Based on Percent Positive Cells, Between Patients Treated With DFMO and Patients Treated With Placebo at 6 Months.
时间窗: at 6 months
The cell DNA damage is measured using the percent positive gastric epithelial cells assessed by IHC for gamma H2AX.The mean difference between the two groups at 6 months will be calculated, accounting for their baseline measurements.
Gastric Epithelial Cell DNA Damage, at 6 Months Versus Baseline
时间窗: Baseline up to 6 months
The cell DNA damage is measured by the percent positive gastric epithelial cells, as assessed by IHC for gamma H2AX. The mean differences at 6 months versus baseline of the percent positive gastric epithelial cells is compared between the two groups.
次要结局
- The Difference in Cell DNA Damage Between Patients Treated With DFMO and Patients Treated With Placebo for 18 Months, and Then Followed for an Additional 6 Months.(at 18 and 24 months)
- The Differences in the Gastritis Histopathology Score Between Patients Treated With DFMO and Patients Treated With Placebo for a Total of 18 Months, and Followed for an Additional 6 Months.(at 6, 18 and 24 months)
- Number of Patients With Quantitative Toxicities.(at 6, 18, and 24 months)
- Gastric Epithelial Cell DNA Damage, at 18 Months Versus Baseline(Baseline up to 18 months)
- Gastric Epithelial Cell DNA Damage, at 24 Months Versus Baseline(Baseline up to 24 months)
- Change in Gastric Histopathology Score, at 6 Months Versus Baseline(Baseline up to 6 months)
- Change in Gastric Histology Score, at 18 Months Versus Baseline(Baseline up to 18 months)
- Change in Gastric Histology Score, at 24 Months Versus Baseline(Baseline up to 24 months)
研究者
Douglas Morgan
Director, Latin America sites, Vanderbilt Institute for Global Health
Vanderbilt-Ingram Cancer Center
研究点 (2)
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