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

Primary Purpose

High Risk Neuroblastoma

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cyclophosphamide
Carboplatin
Etoposide
131I-MIBG
Thiotepa
Melphalan
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Risk Neuroblastoma

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    High risk neuroblastoma

    Arm Description

    Conventional chemotherapy (9 cycles) Surgery conventional chemotherapy (after 6 cycles of chemotherapy) Tandem HDCT/autoSCT First HDCT (cyclophosphamide, etoposide, carboplatin) Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan) Local radiotherapy Retinoic acid, interleukin-2

    Outcomes

    Primary Outcome Measures

    Rate of event free survival
    Event is defined as relapse, disease progression or treatment-related mortality.

    Secondary Outcome Measures

    Rate of treatment-related adverse events as assessed by CTCAE v4.0

    Full Information

    First Posted
    February 20, 2017
    Last Updated
    September 17, 2018
    Sponsor
    Samsung Medical Center
    Collaborators
    Ministry of Health, Republic of Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03061656
    Brief Title
    Tandem High Dose Chemotherapy With 131I-MIBG Treatment in High Risk Neuroblastoma
    Official Title
    High-dose 131I-MIBG Treatment Incorporated Into Tandem High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With High-risk Neuroblastoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2009 (Actual)
    Primary Completion Date
    December 31, 2013 (Actual)
    Study Completion Date
    December 31, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Samsung Medical Center
    Collaborators
    Ministry of Health, Republic of Korea

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High Risk Neuroblastoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High risk neuroblastoma
    Arm Type
    Experimental
    Arm Description
    Conventional chemotherapy (9 cycles) Surgery conventional chemotherapy (after 6 cycles of chemotherapy) Tandem HDCT/autoSCT First HDCT (cyclophosphamide, etoposide, carboplatin) Second HDCT (high-dose 131I-MIBG, thiotepa, melphalan) Local radiotherapy Retinoic acid, interleukin-2
    Intervention Type
    Drug
    Intervention Name(s)
    Cyclophosphamide
    Intervention Description
    1st HDCT
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Intervention Description
    1st HDCT
    Intervention Type
    Drug
    Intervention Name(s)
    Etoposide
    Intervention Description
    1st HDCT
    Intervention Type
    Radiation
    Intervention Name(s)
    131I-MIBG
    Intervention Description
    2nd HDCT
    Intervention Type
    Drug
    Intervention Name(s)
    Thiotepa
    Intervention Description
    2nd HDCT
    Intervention Type
    Drug
    Intervention Name(s)
    Melphalan
    Intervention Description
    2nd HDCT
    Primary Outcome Measure Information:
    Title
    Rate of event free survival
    Description
    Event is defined as relapse, disease progression or treatment-related mortality.
    Time Frame
    Up to 5 years
    Secondary Outcome Measure Information:
    Title
    Rate of treatment-related adverse events as assessed by CTCAE v4.0
    Time Frame
    Up to 5 years

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ki Woong Sung
    Organizational Affiliation
    Samsung Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28511709
    Citation
    Lee JW, Lee S, Cho HW, Ma Y, Yoo KH, Sung KW, Koo HH, Cho EJ, Lee SK, Lim DH. Incorporation of high-dose 131I-metaiodobenzylguanidine treatment into tandem high-dose chemotherapy and autologous stem cell transplantation for high-risk neuroblastoma: results of the SMC NB-2009 study. J Hematol Oncol. 2017 May 16;10(1):108. doi: 10.1186/s13045-017-0477-0.
    Results Reference
    derived

    Learn more about this trial

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

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