NCT00278252Unknown2 期
Phase II Study of Intravenous Etoposide in Patients With Relapsed Ependymoma
Children's Cancer and Leukaemia Group2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2001年7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
- 14
- 试验地点
- 2
- 主要终点
- Response rate by MRI after course 3
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as etoposide, 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 etoposide works in treating young patients with ependymoma.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in young patients with relapsing and/or refractory ependymoma treated with a rapid schedule of intravenous etoposide.
Secondary
- Determine the possibility of second surgery or additional radiotherapy 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 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed intracranial ependymoma at first, second, or third relapse
- •Anaplastic (malignant) or low-grade ependymoma (cellular, papillary, clear cell, or mixed variants)
- •Unequivocal evidence of tumor recurrence or progression by MRI scan after failing conventional treatment (e.g., primary surgery and adjuvant radiotherapy) for initial or recurrent disease
- •Unresectable disease OR not amenable to complete surgical resection
- •Measurable enhancing or non-enhancing disease on baseline scan performed within the past 2 weeks
- •Patients who have undergone prior surgery must have residual measurable disease
- •PATIENT CHARACTERISTICS:
- •Lansky performance status 30-100%
- •Life expectancy ≥ 8 weeks
- •Absolute neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm^3
- •Serum total bilirubin normal
- •AST < 2 times upper limit of normal
- •No unrelated medical condition (e.g., renal or liver impairment) that would preclude chemotherapy treatment
- •No active infection
- •No known HIV positivity
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No radiotherapy within the past 6 weeks
- •No chemotherapy within the past 4 weeks
- •Prior IV etoposide allowed
排除标准
- 未提供
结局指标
主要结局
Response rate by MRI after course 3
次要结局
- Second surgery or additional radiotherapy in responding patients as assessed by MRI scan after course 3 or 6
研究者
研究点 (2)
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