NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2041190105

Registered date:07/01/2020

I-131MIBG therapy for the patients with first relapse of high-risk neuroblastoma

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedneuroblastoma
Date of first enrollment01/01/2020
Target sample size6
Countries of recruitment
Study typeInterventional
Intervention(s)Performing the following treatment protocol when met the entry criteria: 1) Administering 666MBq/kg of I-131MIBG intravenously, generally as an infusion in one hour. 2) Performing high-dose chemotherapy (Bumel: Busulfan, Melphalan) within 14 days of MIBG injection. 3) Performing allogenic blood stem cell transplantation (allo-BSCT) after high-dose chemotherapy.

Outcome(s)

Primary Outcomedose dependent toxicity
Secondary Outcome1) type and frequency of adverse events and reactions. 2) graft survival rate of blood stem cell transplantation. 3) response rate according to RECIST criteria. 4) response rate according to MIBG scan. 5) overall survival period. 6) non-progressive survival period.

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderBoth
Include criteria1) confirmed neuroblastoma. 2) the patient with first relapse and belonging to the high-risk group in COG risk classification or INRG pre-treatment classification system, who are treated with induction treatment according to the guidelines. 3) have one or more 123I-MIBG-avid lesion in relapsed state. 4) have enough blood stem cell source for transplantation. 5) meet ALL 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 total 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 (depending on patient's age).
Exclude criteriaSatisfying ANY of the following conditions. 1) any other current malignancies. 2) diffuse bone marrow involvement on a 123I-MIBG scan. 3) progressive disease by prior treatment. 4) HBV (or carrier), HCV, HIV, or any other active infections currently treated. 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 24,420MBq, the patient over 55kg is excluded. 15) difficult to withdraw any drugs listed in "unrecommended/intolerable combination or supportive therapy" 16) patients who, in the opinion of the attending physician, may not be able to comply with the requirements of the study.

Related Information

Contact

Public contact
Name Anri Inaki
Address 13-1 Takara-machi, Kanazawa Ishikawa Japan 920-8641
Telephone +81-76-265-2333
E-mail henri@staff.kanazawa-u.ac.jp
Affiliation Kanazawa University Hospital
Scientific contact
Name Anri Inaki
Address 13-1 Takara-machi, Kanazawa Ishikawa Japan 920-8641
Telephone +81-76-265-2333
E-mail henri@staff.kanazawa-u.ac.jp
Affiliation Kanazawa University Hospital