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

Last updated: September 17, 2018
Sponsor: Samsung Medical Center
Overall Status: Active - Not Recruiting

Phase

2

Condition

Neuroblastoma

Treatment

N/A

Clinical Study ID

NCT03061656
2011-10-020
  • Ages < 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with high-risk neuroblastoma

Exclusion

Exclusion Criteria:

  • 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

Total Participants: 40
Study Start date:
January 01, 2009
Estimated Completion Date:
December 31, 2018

Study 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.