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Clinical Trials/NCT03061656
NCT03061656UnknownPhase 2

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

Samsung Medical Center0 sites40 target enrollmentStarted: January 1, 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Enrollment
40
Primary Endpoint
Rate of event free survival
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 21 Years (Child, Adult)
Sex
All
Accepts 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

Arms & Interventions

High risk neuroblastoma

Experimental
  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)
  1. Local radiotherapy
  2. Retinoic acid, interleukin-2

Intervention: 131I-MIBG (Radiation)

High risk neuroblastoma

Experimental
  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)
  1. Local radiotherapy
  2. Retinoic acid, interleukin-2

Intervention: Cyclophosphamide (Drug)

High risk neuroblastoma

Experimental
  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)
  1. Local radiotherapy
  2. Retinoic acid, interleukin-2

Intervention: Etoposide (Drug)

High risk neuroblastoma

Experimental
  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)
  1. Local radiotherapy
  2. Retinoic acid, interleukin-2

Intervention: Carboplatin (Drug)

High risk neuroblastoma

Experimental
  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)
  1. Local radiotherapy
  2. Retinoic acid, interleukin-2

Intervention: Thiotepa (Drug)

High risk neuroblastoma

Experimental
  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)
  1. Local radiotherapy
  2. Retinoic acid, interleukin-2

Intervention: Melphalan (Drug)

Outcomes

Primary Outcomes

Rate of event free survival

Time Frame: Up to 5 years

Event is defined as relapse, disease progression or treatment-related mortality.

Secondary Outcomes

  • Rate of treatment-related adverse events as assessed by CTCAE v4.0(Up to 5 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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