Tandem High Dose Chemotherapy With 131I-MIBG Treatment in High Risk Neuroblastoma

High Risk Neuroblastoma Clinical Trial

Official title: High-dose 131I-MIBG Treatment Incorporated Into Tandem High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With High-risk Neuroblastoma

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• High Risk Neuroblastoma
• Neuroblastoma

• NCT number: NCT03061656
• Study type: Interventional
• Source: Samsung Medical Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 1, 2009
• Completion date: December 31, 2018