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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03061656
Enrollment
40
Registered
2017-02-23
Start date
2009-01-01
Completion date
2018-12-31
Last updated
2018-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Risk Neuroblastoma

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.

Interventions

RADIATION131I-MIBG

2nd HDCT

DRUGThiotepa

2nd HDCT

DRUGMelphalan

2nd HDCT

DRUGCyclophosphamide

1st HDCT

DRUGCarboplatin

1st HDCT

DRUGEtoposide

1st HDCT

Sponsors

Ministry of Health, Republic of Korea
CollaboratorOTHER_GOV
Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of event free survivalUp to 5 yearsEvent is defined as relapse, disease progression or treatment-related mortality.

Secondary

MeasureTime frame
Rate of treatment-related adverse events as assessed by CTCAE v4.0Up to 5 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026