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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03061656
• Other study ID #: 2011-10-020
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 1, 2009
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• Patients with high-risk neuroblastoma

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

Related Conditions & MeSH terms

• High Risk Neuroblastoma
• Neuroblastoma

Intervention

Drug:
• Cyclophosphamide
1st HDCT
• Carboplatin
1st HDCT
• Etoposide
1st HDCT

Radiation:
• 131I-MIBG
2nd HDCT

Drug:
• Thiotepa
2nd HDCT
• Melphalan
2nd HDCT

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Ministry of Health, Republic of Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of event free survival	Event is defined as relapse, disease progression or treatment-related mortality.	Up to 5 years
Secondary	Rate of treatment-related adverse events as assessed by CTCAE v4.0		Up to 5 years