A Phase II Study of Navelbine (Vinorelbine) In Children With Recurrent Or Refractory Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 227
- 主要终点
- Disease progression
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer.
详细描述
OBJECTIVES: I. Determine the response rate of children with recurrent or refractory malignancies treated with vinorelbine. II. Assess the toxic effects of this drug in these children.
OUTLINE: Patients receive vinorelbine IV over 6-10 minutes weekly on weeks 1-6. Treatment repeats every 8 weeks for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study within 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Stratum 1 - Soft Tissue Sarcoma
See detailed description.
干预措施: vinorelbine tartrate (Drug)
Stratum 2 - CNS Tumors
See detailed description.
干预措施: vinorelbine tartrate (Drug)
Stratum 3 - Neuroblastoma
See detailed description.
干预措施: vinorelbine tartrate (Drug)
结局指标
主要结局
Disease progression
次要结局
未报告次要终点