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

Phase 2

• Conditions: High Risk Neuroblastoma
• Interventions: Drug: Cyclophosphamide; Drug: Carboplatin; Drug: Etoposide; Radiation: 131I-MIBG; Drug: Thiotepa; Drug: Melphalan

• Registration Number: NCT03061656
• Lead Sponsor: Samsung Medical Center

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 ...

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2013-12-31
• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-18
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with high-risk neuroblastoma

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High risk neuroblastoma	Carboplatin	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
High risk neuroblastoma	Etoposide	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
High risk neuroblastoma	131I-MIBG	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
High risk neuroblastoma	Cyclophosphamide	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
High risk neuroblastoma	Thiotepa	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
High risk neuroblastoma	Melphalan	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

Primary Outcome Measures

Name	Time	Method
Rate of event free survival	Up to 5 years	Event is defined as relapse, disease progression or treatment-related mortality.

Secondary Outcome Measures

Name	Time	Method
Rate of treatment-related adverse events as assessed by CTCAE v4.0	Up to 5 years