UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025045 |
|---|---|
| Receipt number | R000028765 |
| Scientific Title | Prospective study of I-131 3-iodobenzylguanidine radiotherapy for high-risk neuroblastoma; in accordance with the Japanese Advanced Medical Care B program for the anticancer drug with high medical needs. |
| Date of disclosure of the study information | 2016/12/12 |
| Last modified on | 2019/05/27 13:33:39 |
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Basic information
Public title
Prospective study of I-131 3-iodobenzylguanidine radiotherapy for high-risk neuroblastoma; in accordance with the Japanese Advanced Medical Care B program for the anticancer drug with high medical needs.
Acronym
Prospective study of I-131 3-iodobenzylguanidine radiotherapy for high-risk neuroblastoma; in accordance with the Japanese Advanced Medical Care B program for the anticancer drug with high medical needs.
Scientific Title
Prospective study of I-131 3-iodobenzylguanidine radiotherapy for high-risk neuroblastoma; in accordance with the Japanese Advanced Medical Care B program for the anticancer drug with high medical needs.
Scientific Title:Acronym
Prospective study of I-131 3-iodobenzylguanidine radiotherapy for high-risk neuroblastoma; in accordance with the Japanese Advanced Medical Care B program for the anticancer drug with high medical needs.
Region
| Japan |
Condition
Condition
Neuroblastoma
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of I-131 3-iodobenzylguanidine (131I-MIBG) radiotherapy when administered prior to high-dose chemotherapy and hematopoietic stem cell transplantation as a consolidation therapy for high-risk neuroblastoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dose limiting toxicity (DLT).
Key secondary outcomes
Type and frequency of adverse event and reaction.
Engraftment rate of hematopoietic stem cells.
Response rate according to the RECIST criteria.
Response rate according to the scintigraphic evaluation of MIBG.
Overall survival (OS).
Progression-free survival (PFS).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
All patients receive 131I-MIBG at 666 MBq/kg.
Subsequently patients receive high-dose chemotherapy and hematopoietic stem cell transplantation.
Recommended regimen is MEC regimen consisting of melphalan, etoposide, and carboplatin, or BuMel regimen consisting of busulifan and melphalan.
Other regimen is acceptable depending on patient's condition.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) have a definitive diagnosis of neuroblastoma.
2) have high-risk neuroblastoma.
3) have one or more 123I-MIBG-avid lesion at initial presentation or relapse.
4) have enough cryopreserved autologous peripheral blood stem cells, cord blood, or other stem cell cource.
5) meet the following criteria:
Neutrophils >=500/microL
Platelets >=20x10E3/microL, and transfusion independent
Hb >=7.0g/dL
Serum Cr <=0.8mg/dL(<5year), 1.2mg/dL(5-9year), 1.5mg/dL(10-17year)
Creatinine clearance >=70mL/min/1.73m2
ALT <= 5 x upper limit of normal for age
AST <= 5 x upper limit of normal for age
T. Bil <= 3 x upper limit of normal for age
NYHA classification class I or below
SpO2 >=94%
6) ECOG PS 0 or 1, and KPS >=80%
7) be able to cooperate with the radiation safety isolation
8) written informed consent by patients or guardian
Key exclusion criteria
1) active double cancer
2) diffuse bone marrow involvement on a 123I-MIBG scan
3) Progressive disease
4) HBV (or carrier), HCV, HIV, or other active infections
5) history of fatal arrhythmia or asystole
6) concurrent poorly-controlled symptomatic arrhythmia, thyroid dysfunction, respiratory disorder, pleural effusion, or ascites.
7) concurrent coronary artery disease, usage of amiodarone, severe cardiac valvulopathy, aortic disease, or bleeding tendency.
8) woman during pregnancy or lactation, within the 28 postpartum day, desiring pregnancy within 1 year.
9) concurrent poorly-controlled psychiatric disorder
10) allergy to potassium iodide.
11) difficult to cooperate with the radiation safety isolation.
12) concurrent palliative external radiotherapy to painful lesions.
13) past treatment by the same regimen as this study.
14) be unable to receive at least of 444MBq/kg of MIBG due to exceeding of upper limit of radiation use at the center. As the upper limit of our center is 24,000MBq, the patient over 54kg is excluded.
15) Patients who, in the opinion of the attending physician, may not be able to comply with the requirements of the study.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Kinuya |
Organization
Kanazawa University
Division name
Department of Nuclear Medicine, Institute of Medical, Pharmaceutical and Health Sciences
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2333
kinuya@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Raita |
| Middle name | |
| Last name | Araki |
Organization
Kanazawa University
Division name
Department of Pediatrics, Kanazawa University Hospital
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2314
Homepage URL
raraki@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
FUJIFILM RI Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Clinical Research Center, Kanazawa University
Address
13-1 Takara-machi, Kanazawa
Tel
076-265-2090
crc.irb-knz@esct.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 29 | Day |
Last modified on
| 2019 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028765
