High-dose I-131-MIBG therapy for high-risk neuroblastoma preceding myeloablative chemotherapy and hematopoietic stem cell transplantation

JRCT ID: jRCTs041180030

Registered date:23/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Neuroblastoma
• Date of first enrollment: 12/01/2018
• Target sample size: 8
• Study type: Interventional

Intervention(s)

All patients receive 131I-MIBG at 666 MBq/kg.
Subsequently, patients receive high-dose chemotherapy and hematopoietic stem cell transplantation.
The recommended regimen is MEC regimen consisting of melphalan, etoposide, and carboplatin, or BuMel regimen consisting of busulifan and melphalan.
Another regimen is acceptable depending on patient's condition.

Outcome(s)

• Primary Outcome: Dose Limiting Toxicity: DLT

Secondary Outcome

Incidence and type of adverse events
Hematopoietic stem cell engraftment rate
Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST) and 123I-MIBG scintigraphy
Overall survival
Progression-free survival.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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:
5)-1 bone marrow function
1 Neutrophils >=500/microL
2 Platelets >=20x10E3/microL, and transfusion independent
3 Hb >=7.0g/dL
5)-2 Renal function
Serum Cr <=0.8mg/dL(<5year), 1.2mg/dL(5-9year), 1.5mg/dL(10-17year)
Creatinine clearance >=70mL/min/1.73m2
5)-3 Liver function
1 ALT <= 5 x upper limit of normal for age
2 AST <= 5 x upper limit of normal for age
3 T. Bil <= 3 x upper limit of normal for age
5)-4 Cardiac function
NYHA classification class I or below
5)-5 Lung function
SpO2 >=94%
6) ECOG PS 0 or 1
7) be able to cooperate with the radiation safety isolation
8) written informed consent by patients or guardian

Exclude 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.

Related Information

• Primary Sponsor: Wakabayashi Hiroshi
• Source(s) of Monetary Support: FUJIFILM Toyama Chemical Co., Ltd.,Kanazawa University
• Secondary ID(s): UMIN000025045