EUCTR2007-007974-45-DE进行中（未招募）不适用
Phase II trial of the addition of gemcitabine to 131I-MIBG therapy in paediatric patients with relapsed or progressive neuroblastoma - MIBG-Gem
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AMC
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- relapsed or progressive neuroblastoma
- •- age 1 up to 18 years
- •- measurable primary and/or metastatic disease, stage 3 and 4
- •- evidence of sufficient MIBG uptake in bone or soft tissue
- •- Lansky play score over 60 or ECOG 1
- •- adequate organ function
- •- life expectancy > 6 weeks
- •- wash out of prior therapy of 3 weeks; (1 week if vincristine, 6 weeks in case of nitrosureas); 6 months in case of ASCT
- •- written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 47
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- other anti-tumour therapy
- •- symptomatic brain metastasis
- •- contra-indication for nuclear isolation
研究者
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Phase II trial of the combination of gemcitabine and 131I-MIBG therapy in paediatric patients with relapsed or progressive neuroblastomaNL-OMON39557Academisch Medisch Centrum16
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