neuroblastoma
Conditions
Sponsors
Inaki Anri
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =70mL/min/1.73m2 ALT =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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose dependent toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) 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. | — |
Contacts
Public ContactAnri Inaki
Kanazawa University Hospital
Outcome results
None listed