High-dose I-131-MIBG therapy for high-risk neuroblastoma preceding myeloablative chemotherapy and hematopoietic stem cell transplantatio
- Conditions
- euroblastomaHigh-risk neuroblastoma, 131I-MIBG therapyD009447
- Registration Number
- JPRN-jRCTs041180030
- Lead Sponsor
- Wakabayashi Hiroshi
- Brief Summary
The aim of this study is to evaluate the safety, dose-limiting toxicity (DLT), and efficacy of 131I-MIBG therapy combined with myeloablative high-dose chemotherapy and hematopoietic stem cell transplantation in patients with high-risk neuroblastoma. None experienced DLT that hinder subsequent high-dose chemotherapy initiation due to 131I-MIBG therapy. The safety of 131I-MIBG therapy was shown. The response rate was 0% based on RECIST and 63% based on MIBG scintigraphy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 8
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method