High-dose 131I-MIBG Treatment Incorporated Into Tandem High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With High-risk Neuroblastoma
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 主要终点
- Rate of event free survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and toxicity of tandem HDCT/ASCT including high-dose 131I-metaiodobenzylguanidine (MIBG) treatment. In the present study, a single arm trial of tandem HDCT/ASCT will be carried out.
详细描述
Although the outcome of high-risk neuroblastoma has improved after the introduction of HDCT/ASCT, the outcome was still unsatisfactory with 30-40% of survival. We previously reported the results of a single arm prospective trial (SMC NB-2004 study) using tandem HDCT/auto-SCT for high-risk neuroblastoma. In the NB-2004 trial, total body irradiation (TBI) was incorporated in second transplantation. Survival rates were very encouraging; however, short- and long-term toxicities associated with tandem HDCT/auto-SCT, particularly TBI, were also very significant. For this reason, we designed a new prospective trial (SMC NB-2009 study), in which only TBI in the second HDCT/auto-SCT of NB-2004 study was substituted with high-dose 131I-MIBG treatment in order to reduce short- and long-term toxicities without jeopardizing survival rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with high-risk neuroblastoma
排除标准
- •Patients with progressive disease before high-dose chemotherapy
- •Patients whose parents want to stop or change the planned treatment
- •Patients with organ toxicities of NCI grade >2 before high-dose chemotherapy
研究组 & 干预措施
High risk neuroblastoma
- Conventional chemotherapy (9 cycles)
- Surgery conventional chemotherapy (after 6 cycles of chemotherapy)
- Tandem HDCT/autoSCT
- First HDCT (cyclophosphamide, etoposide, carboplatin)
- Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan)
- Local radiotherapy
- Retinoic acid, interleukin-2
干预措施: Cyclophosphamide (Drug)
High risk neuroblastoma
- Conventional chemotherapy (9 cycles)
- Surgery conventional chemotherapy (after 6 cycles of chemotherapy)
- Tandem HDCT/autoSCT
- First HDCT (cyclophosphamide, etoposide, carboplatin)
- Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan)
- Local radiotherapy
- Retinoic acid, interleukin-2
干预措施: Carboplatin (Drug)
High risk neuroblastoma
- Conventional chemotherapy (9 cycles)
- Surgery conventional chemotherapy (after 6 cycles of chemotherapy)
- Tandem HDCT/autoSCT
- First HDCT (cyclophosphamide, etoposide, carboplatin)
- Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan)
- Local radiotherapy
- Retinoic acid, interleukin-2
干预措施: Etoposide (Drug)
High risk neuroblastoma
- Conventional chemotherapy (9 cycles)
- Surgery conventional chemotherapy (after 6 cycles of chemotherapy)
- Tandem HDCT/autoSCT
- First HDCT (cyclophosphamide, etoposide, carboplatin)
- Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan)
- Local radiotherapy
- Retinoic acid, interleukin-2
干预措施: 131I-MIBG (Radiation)
High risk neuroblastoma
- Conventional chemotherapy (9 cycles)
- Surgery conventional chemotherapy (after 6 cycles of chemotherapy)
- Tandem HDCT/autoSCT
- First HDCT (cyclophosphamide, etoposide, carboplatin)
- Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan)
- Local radiotherapy
- Retinoic acid, interleukin-2
干预措施: Thiotepa (Drug)
High risk neuroblastoma
- Conventional chemotherapy (9 cycles)
- Surgery conventional chemotherapy (after 6 cycles of chemotherapy)
- Tandem HDCT/autoSCT
- First HDCT (cyclophosphamide, etoposide, carboplatin)
- Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan)
- Local radiotherapy
- Retinoic acid, interleukin-2
干预措施: Melphalan (Drug)
结局指标
主要结局
Rate of event free survival
时间窗: Up to 5 years
Event is defined as relapse, disease progression or treatment-related mortality.
次要结局
- Rate of treatment-related adverse events as assessed by CTCAE v4.0(Up to 5 years)