- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03061656
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
|
1st HDCT
1st HDCT
1st HDCT
2nd HDCT
2nd HDCT
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
Collaborators
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.
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
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Neuroblastoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Cyclophosphamide
- Carboplatin
- Etoposide
- Melphalan
- Thiotepa
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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