NCT00213278已完成2 期
A Phase 2 Study of Vinblastine Sulphate Injection in Children With Recurrent or Refractory Low Grade Glioma
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
- 50
- 试验地点
- 1
- 主要终点
- To determine the response rate to Vinblastine in recurrent low grade glioma of childhood
研究概览
简要总结
This study is examining whether Vinblastine is an effective drug to shrink low grade glioma brain tumors in children, and what the side effects are.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 21 years of age at original diagnosis
- •histological verification of low grade glioma (glial tumors, neuronal tumors or chiasmatic-hypothalamic tumor) at original diagnosis
- •evidence of tumor recurrence or progression by MRI or contrast CT
- •Karnofsky and Lansky performance status of 0,1 or 2
- •life expectancy of greater than or equal to 2 months
- •adequate organ and bone marrow function within 7 days of starting treatment with Vinblastine
- •absolute neutrophil count (ANC)> 1000/uL
- •platelet count > 100,000/uL (transfusion independent)
- •serum creatinine < 1.5 x normal for age
- •written informed consent signed by subject and/or subject's parent/legal guardian
排除标准
- •not recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy
- •chemotherapy within 2 weeks of entry in study (4 weeks if prior nitrosourea was used)
- •less than 7 days since the completion of therapy with a biologic agent
- •less than 2 months since cranial/spinal radiation
- •receiving a stable dose of dexamethasone for less than one week
研究组 & 干预措施
1
Experimental
干预措施: vinblastine sulphate injection (Drug)
结局指标
主要结局
To determine the response rate to Vinblastine in recurrent low grade glioma of childhood
时间窗: 52 weeks
次要结局
- To further assess the toxicity of weekly vinblastine in children treated at the currently defined maximally tolerated dose (MTD) of Vinblastine(52 weeks)
研究者
Eric Bouffet
Section Head, Neuro-Oncology
The Hospital for Sick Children
研究点 (1)
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