Tandem High Dose Chemotherapy With 131I-MIBG Treatment in High Risk Neuroblastoma
High-dose 131I-MIBG Treatment Incorporated Into Tandem High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With High-risk Neuroblastoma
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2009
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2013
CompletedFirst Submitted
Initial submission to the registry
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedSeptember 18, 2018
September 1, 2018
5 years
February 20, 2017
September 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of event free survival
Event is defined as relapse, disease progression or treatment-related mortality.
Up to 5 years
Secondary Outcomes (1)
Rate of treatment-related adverse events as assessed by CTCAE v4.0
Up to 5 years
Study Arms (1)
High risk neuroblastoma
EXPERIMENTAL1. 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
Interventions
Eligibility Criteria
You may qualify if:
- Patients with high-risk neuroblastoma
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Ministry of Health, Republic of Koreacollaborator
Related Publications (1)
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.
PMID: 28511709DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ki Woong Sung
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2017
First Posted
February 23, 2017
Study Start
January 1, 2009
Primary Completion
December 31, 2013
Study Completion
December 31, 2018
Last Updated
September 18, 2018
Record last verified: 2018-09