NCT00287924Unknown2 期
Phase II Study of High-Dose Methotrexate in Children With Residual Ependymoma
Children's Cancer and Leukaemia Group41 个研究点 分布在 2 个国家目标入组 29 人开始时间: 2005年3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
- 29
- 试验地点
- 41
- 主要终点
- Activity of high-dose methotrexate at 6 weeks
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as methotrexate, 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 high-dose methotrexate works in treating young patients with residual ependymoma.
详细描述
OBJECTIVES:
Primary
- Determine the activity of high-dose methotrexate as upfront-window therapy in young patients with residual ependymoma.
Secondary
- Assess the reasons why primary surgery was complete/incomplete in these patients.
- Assess the feasibility and toxicity of second-look surgery after 3 courses of high-dose methotrexate in cases where initial surgery was incomplete.
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 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ependymoma, including the following histologic variants:
- •Papillary
- •Clear-cell
- •Tanycytic
- •Anaplastic (malignant) ependymoma
- •The following diagnoses are excluded:
- •Myxopapillary ependymoma
- •Subependymomas
- •Ependymoblastomas
- •Primitive neuroectodermal tumors (PNETs)
- •Other neuroepithelial tumors
- •Choroid plexus tumors
- •Germ cell tumors
- •Residual measurable ependymoma after maximal surgical resection, including second-look surgery, if deemed necessary
- •Has undergone surgical resection within the past 3 weeks
- •PATIENT CHARACTERISTICS:
- •At least 3 months to under 3 years of age
- •Neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm^3
- •Able to tolerate chemotherapy
- •No co-existent unrelated disease (i.e., renal or hematological) that would preclude chemotherapy treatment
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from prior surgery
- •No previous chemotherapy
- •Previous steroids allowed
- •No previous radiotherapy
排除标准
- 未提供
结局指标
主要结局
Activity of high-dose methotrexate at 6 weeks
次要结局
- Assess reasons why primary surgery is complete or incomplete at diagnosis
- Feasibility and toxicity of second look surgery after course 3 at 2 months
- Compare functional imaging studies of ependymomas with biological characteristics of the tumors at diagnosis
研究者
研究点 (41)
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