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

September 17, 2018 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Drug: Cyclophosphamide
1st HDCT
Drug: Carboplatin
1st HDCT
Drug: Etoposide
1st HDCT
Radiation: 131I-MIBG
2nd HDCT
Drug: Thiotepa
2nd HDCT
Drug: Melphalan
2nd HDCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of event free survival
Time Frame: Up to 5 years
Event is defined as relapse, disease progression or treatment-related mortality.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Ministry of Health, Republic of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2009

Primary Completion (ACTUAL)

December 31, 2013

Study Completion (ANTICIPATED)

December 31, 2018

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (ACTUAL)

February 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-10-020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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