PBTC-018: A PHASE I TRIAL OF CC-5013 (LENALIDOMIDE)

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项CC-5013的儿科I期试验，用于复发或难治性脑肿瘤的儿童，以确定CC-5013的MTD和安全性。CC-5013将每天口服一次，为期21天，为期28天。它类似于沙利度胺，具有广泛的药理、抗血管生成和免疫学作用。如果受试者没有出现不可接受的毒性或疾病进展，疗程可以持续两年。 这项研究的目标是： 评估口服CC-5013治疗儿童复发或难治性原发中枢神经系统肿瘤的MTD，每天一次，共28天，疗程21天 描述CC-5013在儿童复发或难治性原发中枢神经系统肿瘤中的毒性分布并确定其剂量限制性毒性 CC-5013在儿童和青少年体内的药代动力学研究 目的：观察CC-5013治疗后循环内皮细胞(CECs)和循环内皮细胞前体(CEPs)的变化，探讨CECs与CECs、血浆、血清和尿液中与血管生成相关的蛋白水平的相关性，包括凝血酶反应蛋白、b-成纤维细胞生长因子、肿瘤坏死因子-α、白介素12、白介素8和血管内皮生长因子的变化，并将这些变化与MR血流灌注和临床预后的变化相关联。 评价治疗过程中磁共振波谱、磁共振血流灌注和弥散的变化。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a pediatric phase I trial of CC-5013 performed in children with recurrent or refractory brain tumors, to determine the MTD and safety profile of CC-5013. CC-5013 will be given orally once a day for 21 days of a 28-day course. It is similar to thalidomide and has a wide variety of pharmacologic, antiangiogenic and immunologic effects. Courses may continue for two years provided the subject does not develop unacceptable toxicity or disease progression. The objectives of this study are: To estimate the MTD of oral CC-5013 administered to children with recurrent or refractory primary CNS tumors once daily for 21 days of a 28 day course To describe the toxicity profile and define the dose-limiting toxicity of CC-5013 in children with recurrent or refractory primary CNS tumors To characterize the pharmacokinetics of CC-5013 in children and adolescents To evaluate changes in circulating endothelial cells (CECs) and circulating endothelial cell precursors (CEPs) in patients treated with CC-5013, and to investigate the correlation between changes in CECs and CEPs, plasma, serum and urine levels of proteins associated with angiogenesis including thrombospondin, b-FGF, TNF- , IL-12, IL-8 and VEGF, and correlate these changes with changes in MR perfusion and clinical outcome To evaluate changes in MR spectroscopy, MR perfusion and diffusion during treatment.