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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-01

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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High Risk Neuroblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High risk neuroblastoma

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

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

1st HDCT

Carboplatin

Intervention Type DRUG

1st HDCT

Etoposide

Intervention Type DRUG

1st HDCT

131I-MIBG

Intervention Type RADIATION

2nd HDCT

Thiotepa

Intervention Type DRUG

2nd HDCT

Melphalan

Intervention Type DRUG

2nd HDCT

Interventions

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Cyclophosphamide

1st HDCT

Intervention Type DRUG

Carboplatin

1st HDCT

Intervention Type DRUG

Etoposide

1st HDCT

Intervention Type DRUG

131I-MIBG

2nd HDCT

Intervention Type RADIATION

Thiotepa

2nd HDCT

Intervention Type DRUG

Melphalan

2nd HDCT

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No