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

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。 新诊断的非播散性、固有脑干胶质瘤和非播散性高级别胶质瘤的儿童患者对口服卡培他滨的耐受性良好。 ISPECIFIC AIMS 主要目标： 1.评估卡培他滨在放射治疗(RT)的同时对新诊断的非播散性固有脑干胶质瘤或新诊断的非播散性高级别胶质瘤的最大耐受量(MTD)。 2.描述卡培他滨在放射治疗的同时对儿童新诊断的非播散性、固有脑干胶质瘤或新诊断的非播散性高级别胶质瘤的剂量限制性毒性。 次要目标： 1.研究卡培他滨快速崩解片在儿科患者中的药代动力学。 2.在这项第一阶段研究的背景下，描述在新诊断的非播散性固有脑干胶质瘤或新诊断的非播散性高级别胶质瘤的儿童中观察到的卡培他滨和放射的抗肿瘤活性。 3.应用MRI、MRS、灌注弥散成像和正电子发射计算机体层摄影(PET)技术，研究放射治疗和卡培他滨联合治疗的非播散性脑干胶质瘤和高级别脑干胶质瘤的X线表现。

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.