Tandem High Dose Chemotherapy With 131I-MIBG Treatment in High Risk Neuroblastoma
- Conditions
- High Risk Neuroblastoma
- Interventions
- Registration Number
- NCT03061656
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Patients with high-risk neuroblastoma
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High risk neuroblastoma Carboplatin 1. Conventional chemotherapy (9 cycles) 2. Surgery conventional chemotherapy (after 6 cycles of chemotherapy) 3. Tandem HDCT/autoSCT * First HDCT (cyclophosphamide, etoposide, carboplatin) * Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan) 4. Local radiotherapy 5. Retinoic acid, interleukin-2 High risk neuroblastoma Etoposide 1. Conventional chemotherapy (9 cycles) 2. Surgery conventional chemotherapy (after 6 cycles of chemotherapy) 3. Tandem HDCT/autoSCT * First HDCT (cyclophosphamide, etoposide, carboplatin) * Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan) 4. Local radiotherapy 5. Retinoic acid, interleukin-2 High risk neuroblastoma 131I-MIBG 1. Conventional chemotherapy (9 cycles) 2. Surgery conventional chemotherapy (after 6 cycles of chemotherapy) 3. Tandem HDCT/autoSCT * First HDCT (cyclophosphamide, etoposide, carboplatin) * Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan) 4. Local radiotherapy 5. Retinoic acid, interleukin-2 High risk neuroblastoma Cyclophosphamide 1. Conventional chemotherapy (9 cycles) 2. Surgery conventional chemotherapy (after 6 cycles of chemotherapy) 3. Tandem HDCT/autoSCT * First HDCT (cyclophosphamide, etoposide, carboplatin) * Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan) 4. Local radiotherapy 5. Retinoic acid, interleukin-2 High risk neuroblastoma Thiotepa 1. Conventional chemotherapy (9 cycles) 2. Surgery conventional chemotherapy (after 6 cycles of chemotherapy) 3. Tandem HDCT/autoSCT * First HDCT (cyclophosphamide, etoposide, carboplatin) * Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan) 4. Local radiotherapy 5. Retinoic acid, interleukin-2 High risk neuroblastoma Melphalan 1. Conventional chemotherapy (9 cycles) 2. Surgery conventional chemotherapy (after 6 cycles of chemotherapy) 3. Tandem HDCT/autoSCT * First HDCT (cyclophosphamide, etoposide, carboplatin) * Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan) 4. Local radiotherapy 5. Retinoic acid, interleukin-2
- Primary Outcome Measures
Name Time Method Rate of event free survival Up to 5 years Event is defined as relapse, disease progression or treatment-related mortality.
- Secondary Outcome Measures
Name Time Method Rate of treatment-related adverse events as assessed by CTCAE v4.0 Up to 5 years