NCT00180947Unknown2 期
Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse
研究概览
简要总结
This is a phase II study to determine the antitumor activity of Vinorelbine and Cyclofosfamide association among patients with refractory tumours or in relapse with rhabdomyosarcomas and other soft tissue tumours, Ewing tumours, osteosarcomas, neuroblastomas or medulloblastomas.
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
- 12 Months 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 12 months and < 25 years
- •Measurable disease
- •Score of Lansky > 30 or World Health Organization (WHO) score < 2
- •Life expectancy > 2 months
- •Satisfactory hematologic conditions:
- •Polynuclear neutrophiles > 1 X 10^9/l.
- •Platelets > 100 X 10^9/l or > 50 X 10^9 in the event of medullary invasion.
- •Creatinine < 1.5 of normal for age or clearance > 70 ml/min/1.73 m2
- •Normal hepatic function:
- •Bilirubin < 3 N
- •ASAT and ALAT < 2,5 N).
- •Absence of toxicity of bodies (Rank > 2 according to coding National Cancer Institute-Common Toxicity Criteria [NCI-CTC] version 2.0)
- •Absence of antecedent of hematuric cystitis to repetition
- •Written consent, signed by the patient or the two parents or holder(s) of the parental authority of the minor subjects
排除标准
- •Does not satisfy the criteria of eligibility
结局指标
主要结局
To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse
次要结局
- To evaluate the hematologic tolerance of this association
- To evaluate the pharmacokinetics of injectable Vinorelbine
研究者
研究点 (2)
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