Neuroblastoma
Conditions
Interventions
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 melph
Sponsors
Kanazawa University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity (DLT). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
Public ContactRaita Araki
Kanazawa University Department of Pediatrics, Kanazawa University Hospital
Outcome results
None listed