ADVL0419: APHASE 1 STUDY OF VALPROIC ACID IN CHILDREN WITH RECURRENT/PROGRESSIV

ADVL0419：丙戊酸在复发/进展儿童中的 A 期 1 研究

• 批准号: 7376226
• 负责人: NITA L. SEIBEL
• 金额: $ 0.05万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376226
• 关键词: ADVL0419; APHASE; STUDY; VALPROIC; ACID

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. The primary aim of this study is to define and describe the toxicities of oral valproic acid (VPA) administered twice daily at doses required to maintain serum trough concentrations of 100-150 mcg/ml or 150-200 mcg/ml in children with recurrent or refractory solid tumors, including CNS tumors. The secondary aims are: 1) To measure the steady state of serum trough concentration of free VPA at targeted total trough VPA concentraion. 2) To evaluate the pharmacokinetic profile of twice daily VPA administration in children. 3) To evaluate the steady state histone acetylation status of peripheral blood monocytes at the targeted trough VPA concentrations. 4) To investigate potential correlations between histone acetylation and free or total VPA trough concentrations. 5) To preliminary define the antitumor activity of VPA within the confines of a Phase 1 trial.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。这项研究的主要目的是定义和描述每天两次服用口服丙戊酸（VPA）的毒性，以维持100-150 mcg/ml或150-200 mcg/ml的血清槽浓度，或150-200 mcg/ml，患有包括CNS肿瘤在内的复发性或过度实用的固体性固体剂量。次要目的是：1）测量目标总VPA浓度下游离VPA的血清谷浓度的稳态。 2）评估儿童每日VPA给药两次的药代动力学特征。 3）评估靶向槽VPA浓度下外周血单核细胞的稳态组蛋白乙酰化状态。 4）研究组蛋白乙酰化与游离或总VPA槽浓度之间的潜在相关性。 5）初步定义VPA在1阶段试验范围内的抗肿瘤活性。