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

这个子项目是许多利用资源的研究子项目之一 由NIH/NCRR资助的中心拨款提供。子项目的主要支持 而子项目的主要调查员可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 这是一个第二阶段的协议，为儿童新诊断的，弥漫性内在脑干胶质瘤。 放射期卡培他滨RDT剂量为650 mg/m2，每日两次，基于I期儿科试验中卡培他滨的儿科MTD和伴随RT。在没有不可接受的不良事件的情况下，不应中断卡培他滨给药。口服卡培他滨RDT将持续总共9周，然后休息2周。RT后治疗将在两周休息后开始。放射治疗后，患者将接受每日两次口服卡培他滨，持续3个疗程。在每个疗程中，卡培他滨将连续给药14天，然后停药7天。 卡培他滨将以调味、薄膜包衣、快速崩解片剂的形式提供，对于无法吞咽片剂的患者，可完整吞咽或分散在水中。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. This is a phase II protocol for children with newly diagnosed, diffuse intrinsic brain stem gliomas. Capecitabine RDT dosing during the radiation phase will be 650 mg/m2 administered twice daily and is based on the pediatric MTD of capecitabine with concomitant RT from the phase I pediatric trial. There should be no interruptions in capecitabine administration in the absence of unacceptable adverse event. Oral capecitabine RDT will continue for a total of nine weeks, followed by a two-week break. Post-RT therapy will begin after the two week break. Post radiation therapy, patients will receive twice daily oral capecitabine for 3 courses. During each course, capecitabine will be administered for 14 consecutive days followed by a 7-day rest period. Capecitabine will be provided as a flavored, film coated, rapidly disintegrating tablet that may be swallowed intact or dispersed in water for patients unable to swallow tablets.