EUCTR2020-004445-36-DK进行中（未招募）1 期
A phase II trial of 177Lutetium-DOTATATE in children with primary refractory or relapsed high-risk neuroblastoma. - LuDO
Karolinska University Hospital0 个研究点目标入组 25 人开始时间: 2021年2月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Pathology
- •1.1. Histologically confirmed diagnosis of neuroblastoma
- •1.2. Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available
- •2. Relapsed or primary refractory high-risk neuroblastoma: INSS stage 4 disease or INRGSS stage M disease
- •3. Age >18 months at the time of enrolment into this study
- •4. Life expectancy of greater than 3 months
- •5. Performance Status
- •5.1. Karnofsky > 50% (for patients > 12 years of age)
- •5.2. Lansky > 50% (for patients = 12 years of age)
- •6. Prior treatment
- •6.1. Two-week washout from any prior treatment
- •6.2. Patients must have recovery of hematological toxicity following previous therapy 6.3. Adequate recovery from major surgery prior to receiving study treatment
- •7. Diagnostic imaging
- •7.1. Uptake in the primary tumor or metastatic tumour deposits on 68Ga-DOTATATE PET/CT at least higher than the liver uptake and performed within two months prior to registration
- •7.2. 123I-mIBG scintigraphy to be performed within two months prior to registration
- •7.3. CT or MRI of the primary tumor and bulky metastatic sites within two months prior to registration
- •8. Laboratory requirements to be performed within 7 days prior to commencing trial treatment:
- •8.1. Hematology:
- •8.1.1. Hemoglobin, If Hb is <120 g/L then patient will receive a blood transfusion prior to commencing trial treatment
- •8.1.2. Absolute neutrophil count > 1.0 x 109/L 8.1.3. Absolute Platelets > 100 x 109/L
- •8.2. Biochemistry:
- •8.2.1. Bilirubin within 1.5 x ULN
- •8.2.2. ALT within 2.5 x ULN
- •8.2.3 AST within 2.5 x ULN
- •8.2.4 GGT within 5 x ULN
- •8.2.5. ALP within 5 x ULN
- •8.2.6. Glomerular filtration rate >50mL/min/1.73m2 assessed by a recognised method, such as inulin, 51Cr-EDTA, 99mTc-DTPA or iohexol clearance and performed within 2 months prior to registration
- •8.2.7. Urinary catecholamine metabolites measured within 2 months prior to registration
- •9. Peripheral blood stem cells (PBSC)
- •9.1. A minimum of 2 x106 CD34+ cells/kg (optimally 6 x106 CD34+ cells/kg) must be available for each study subject prior to registering
- •10. Written informed consent from patient and/or parent(s) or legal guardian(s) in accordance with national regulations, prior to registration or any trial-related screening procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Not fit enough to undergo proposed study treatment, as assessed by national PI, considering precautions defined in the latest version of the Lutathera SmPC
- •2. Pregnant or lactating patient
- •3. Concurrent treatment with any anti-tumor agents
- •4. Prior treatment with other radiolabeled somatostatin analogues
- •5. Hypersensitivity to any component of the investigational drug Lutathera®
- •6. Treatment with long-acting somatostatin analogues within 30 days prior the administration of Lutathera®
研究者
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