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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 口服卡培他滨在新诊断的非弥散性、内源性脑干胶质瘤和非弥散性高级别胶质瘤儿科患者中耐受性良好。 ISPECIFIC AIMS 主要目的： 1.探讨卡培他滨联合放疗治疗儿童非播散性脑干胶质瘤和非播散性高级别胶质瘤的最大耐受剂量（MTD）。 2.描述卡培他滨联合放疗治疗儿童新诊断的非播散性、内源性脑干胶质瘤或新诊断的非播散性高级别胶质瘤的剂量限制性毒性。 次要目的： 1.研究卡培他滨速崩片在儿童患者中的药代动力学特征。 2.在这项第一阶段研究的背景下，描述卡培他滨和放射治疗在新诊断的非弥散性、固有的脑干胶质瘤或新诊断的非弥散性高级别胶质瘤儿童中观察到的抗肿瘤活性。 3.应用MRI、MRS、灌注和弥散成像及PET扫描对非播散型、新诊断的脑干内源性胶质瘤和高级别胶质瘤放射治疗后的影像学改变进行研究。