NCT00287976Unknown2 期
Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma
Children's Cancer and Leukaemia Group43 个研究点 分布在 3 个国家目标入组 30 人开始时间: 2003年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 43
- 主要终点
- Best overall response (complete response and partial response)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well irinotecan works in treating young patients with refractory or recurrent hepatoblastoma.
详细描述
OBJECTIVES:
Primary
- Determine the biological activity of irinotecan hydrochloride, when given on a prolonged schedule, in terms of response rate and rate of early progression, in young patients with refractory or recurrent hepatoblastoma.
Secondary
- Determine the duration of response in patients showing stable disease or an objective response (partial or complete response) to this drug.
- Determine the time to progression and overall survival of patients treated with this drug.
- Determine the rate of resectability in patients treated with this drug.
- Determine the toxicity of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of hepatoblastoma
- •Refractory or recurrent disease
- •Failed prior first-line or second-line treatment
- •Metastatic disease allowed
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Elevated serum alpha-fetoprotein (AFP) allowed
- •No hepatocellular carcinoma
- •PATIENT CHARACTERISTICS:
- •Lansky performance status 50-100% in patients ≤ 10 years of age OR Karnofsky performance status 50-100% in patients > 10 years of age
- •Life expectancy > 8 weeks
- •Hemoglobin > 8 g/dL
- •Absolute neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm^3
- •Serum bilirubin ≤ 2 times normal
- •AST/ALT ≤ 2 times normal
- •Serum creatinine ≤ 3 times normal
- •Normal metabolic parameters (i.e., serum electrolytes, glucose, calcium, and phosphate)
- •Not pregnant or nursing
- •No severe uncontrolled infection or enterocolitis
- •PRIOR CONCURRENT THERAPY:
- •Recovered from toxicity of prior therapy
- •No chemotherapy within 3 weeks prior to study entry
- •No prior irinotecan
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Best overall response (complete response and partial response)
次要结局
- Early progression
- Death
- Disease progression or recurrence
- Surgical resection (complete or incomplete)
研究者
研究点 (43)
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