JPRN-jRCTs041180030已完成1 期
Feasibility of high-dose iodine-131-metaiodobenzylguanidine therapy for high-risk neuroblastoma preceding myeloablative chemotherapy and hematopoietic stem cell transplantation - High-dose iodine-131-metaiodobenzylguanidine therapy for high-risk neuroblastoma
Wakabayashi Hiroshi0 个研究点目标入组 8 人开始时间: 2019年1月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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