CTIS2023-503684-42-00进行中（未招募）1 期
A phase II trial of 177Lutetium-DOTATATE in children with primary refractory or relapsed high-risk neuroblastomaLuDO-N - LuDO
Karolinska University Hospital0 个研究点目标入组 24 人开始时间: 2023年3月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 64（—）
- 性别
- All
入选标准
- •Pathology: 1.1. Histologically confirmed diagnosis of neuroblastoma, 1.2 Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available, 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, Relapsed or primary refractory high-risk neuroblastoma: INSS stage 4 disease or INRGSS stage M disease, Age >18 months at the time of enrolment into this study, Life expectancy of greater than 3 months, Performance Status: 5.1. Karnofsky > 50% (for patients > 12 years of age), 5.2. Lansky > 50% (for patients = 12 years of age), 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, 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, 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 > 50 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 prior to registration 8.2.7. Urinary catecholamine metabolites measured within 2 months prior to registration, 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 registration
排除标准
- •Not fit enough to undergo proposed study treatment, as assessed by national PI, considering precautions defined in the latest version of the Lutathera SmPC., Pregnant or lactating patient, Concurrent treatment with any anti-tumor agents, Prior treatment with other radiolabeled somatostatin analogues, Hypersensitivity to any component of the investigational drug 177Lutetium-DOTATATE, Treatment with long-acting somatostatin analogues within 30 days, or with short-acting somatostatin analogues within 24 hours prior the administration of 177Lutetium-DOTATATE
研究者
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