CLINICAL TRIAL: A PHASE I TRIAL OF CAPECITABINE RAPIDLY DISINTEGRATING TABLETS A

临床试验：卡培他滨快速崩解片 A 的 I 期试验

• 批准号: 8166682
• 负责人: SUSAN M. BLANEY
• 金额: $ 3.47万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166682
• 关键词: Brain Stem Glioma; Child; Childhood; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Diffusion; Dose-Limiting; Drug Kinetics; Funding; Glioma; Grant; Image; Institution; Investigation; Magnetic Resonance Imaging; Maximum Tolerated Dose; Newly Diagnosed; Oral; Patients; Perfusion; Phase; Positron-Emission Tomography; Radiation; Radiation therapy; Research; Research Personnel; Resources; Source; Tablets; Toxic effect; United States National Institutes of Health; capecitabine; patient population; tumor

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. Oral capecitabine will be well tolerated by pediatric patients with newly diagnosed nondisseminated, intrinsic brainstem gliomas and non-disseminated high-grade gliomas. ISPECIFIC AIMS Primary Objectives: 1.To estimate the maximum tolerated dose (MTD) of capecitabine administered concurrently with radiation therapy (RT) to children with newly diagnosed nondisseminated, intrinsic brainstem gliomas or newly diagnosed non-disseminated high-grade gliomas. 2.To describe the dose-limiting toxicity (ies) of capecitabine administered concurrently with radiation therapy to children with newly diagnosed nondisseminated, intrinsic brainstem gliomas or newly diagnosed non-disseminated high-grade gliomas. Secondary Objectives: 1.To characterize the pharmacokinetics of capecitabine as delivered by Capecitabine Rapidly Disintegrating Tablets in this pediatric patient population. 2.To describe in the context of this phase 1 investigation, the anti-tumor activity of capecitabine and radiation that is observed in children with newly diagnosed nondisseminated, intrinsic brainstem gliomas or newly diagnosed non-disseminated high-grade gliomas. 3.To characterize radiographic changes in non-disseminated, newly diagnosed intrinsic brainstem gliomas and high-grade gliomas treated with radiation and capecitabine using MRI, MRS, perfusion and diffusion imaging and PET scans.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 新诊断的非播散性内源性脑干胶质瘤和非播散性高级胶质瘤的儿科患者对口服卡培他滨有良好的耐受性。 具体目标 主要目标： 1. 评估新诊断的非播散性内源性脑干胶质瘤或新诊断的非播散性高级别胶质瘤儿童与放射治疗（RT）同时使用的卡培他滨的最大耐受剂量（MTD）。 2.描述卡培他滨与放射治疗同时给予新诊断的非播散性内源性脑干胶质瘤或新诊断的非播散性高级别胶质瘤儿童的剂量限制毒性。 次要目标： 1. 表征卡培他滨速崩片在该儿科患者群体中的药代动力学。 2. 描述在第一阶段研究的背景下，在新诊断的非播散性内源性脑干胶质瘤或新诊断的非播散性高级别胶质瘤儿童中观察到的卡培他滨和放射的抗肿瘤活性。 3. 使用 MRI、MRS、灌注和扩散成像以及 PET 扫描来表征经放射和卡培他滨治疗的非播散性、新诊断的内在性脑干胶质瘤和高级别胶质瘤的放射学变化。