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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025045
Receipt No. 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

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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
Email 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
Email raraki@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028765

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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