COG ADVL0419: VALPROIC ACID IN CHILDREN WITH RECURRENT/PROGRESSIVE SOLID TUMORS

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。 丙戊酸已经被FDA批准，但还没有被专门批准用于治疗患有实体肿瘤的儿童。目前尚不清楚丙戊酸是否会杀死儿童体内的肿瘤细胞，也不知道体内杀死肿瘤细胞所需的最低水平的药物是什么，因此，这项研究的主要目标是了解癌症儿童是否可以安全地服用高于癫痫患者通常给予的水平的丙戊酸。这项研究的其他目的是了解当癌症儿童服用丙戊酸的剂量高于癫痫患者通常给予的剂量时，他们会产生何种副作用，实体肿瘤儿童对丙戊酸的处理方式是否与癫痫儿童有任何不同(称为药代动力学研究，或PK研究)，以及研究丙戊酸是否导致组蛋白乙酰化(我们认为正常或肿瘤细胞中的一种生物变化会杀死肿瘤细胞)。除第一个疗程外，每个疗程持续28天(或4周)，其持续时间可能远远超过28天(从5到10周)。在第一个疗程后，丙戊酸的剂量将保持在目标水平的血液丙戊酸。最多可以进行12个疗程的治疗。

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. Valproic acid has been approved by the FDA, but has not been approved specifically for treating children with solid tumors. It is not known if valproic acid will kill tumor cells in children, or what the lowest level of drug needed in the body is to kill tumor cells, therefore, the major goal of the study is to learn if children with cancer can safely take valproic acid at levels higher than those commonly given to epilepsy patients. Other goals of this study are to learn what kinds of side effects happen in children with cancer when they take valproic acid at a higher dose than is commonly given to epilepsy patients, to learn if children with solid tumors handle valproic acid any differently than children with epilepsy (called a pharmacokinetic study, or PK study), and to study whether valproic acid causes histone acetylations (a biological change in normal or tumor cells which we believe is responsible for killing tumor cells). Each course of therapy lasts 28 days (or 4 weeks), except for the first course, which may last much longer than 28 days (from 5 to 10 weeks). After the first course, valproic acid will be given at the dose found to maintain blood valproic acid at the target level. A maximum of 12 courses of therapy may be administered.