NCT00798148Unknown1 期
Evaluation of Benefit and Side Effects of 131I-MIBG in Combination With Myeloablative Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for the Treatment of High-risk Neuroblastoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Response (complete response, very good partial response, and partial response) at one-years post stem cell transplantation
研究概览
简要总结
This trial is studying how well iodine I 131 metaiodobenzylguanidine together with combination chemotherapy works in treating patients who are undergoing an autologous peripheral stem cell for high risk or relapsed neuroblastoma.
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 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Neuroblastoma and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites
- •High risk according COG (Children Oncology Group)OR Relapse OR Refractory
- •As at least one I131-MIBG avid target lesion determined by diagnostic MIBG scan
- •Glomerular filtration rate or creatinine clearance > 60 ml/min
- •No tumor cell in Bone Marrow by routine morphology aspiration and biopsy before peripheral stem cell collection
- •No active infection
排除标准
- •Impaired renal function
- •No avid I131-MIBG lesion
- •Active infection
研究组 & 干预措施
MIBG
Experimental
干预措施: 131I-MIBG , Etoposide, Melphalan, Carboplatin, Autologous Peripheral Stem Cell Transplantation (Drug)
结局指标
主要结局
Response (complete response, very good partial response, and partial response) at one-years post stem cell transplantation
时间窗: one-years post stem cell transplantation
次要结局
- Overall survival(one-year after stem cell tranplantation)
研究者
研究点 (2)
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