I-131MIBG therapy for the patients with newly diagnosed high-risk neuroblastoma

Inaki Anri0 个研究点目标入组 6 人开始时间: 2020年1月7日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) confirmed neuroblastoma.
•2) the patient newly diagnosed 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 at initial presentation.
•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).

•Satisfying 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.

发起方

Inaki Anri