跳至主要内容
临床试验/NCT00213278
NCT00213278已完成2 期

A Phase 2 Study of Vinblastine Sulphate Injection in Children With Recurrent or Refractory Low Grade Glioma

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2002年1月最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Bouffet

Section Head, Neuro-Oncology

The Hospital for Sick Children

研究点 (1)

Loading locations...

相似试验