PBTC 007 V10B- A PHASE I/II TRIAL OF ZD 1839 (IRESSA)

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。新诊断的内在脑干胶质瘤(BSG)和未完全切除的幕上恶性胶质瘤(STMG)在影像上有肿瘤残留的儿童将符合这项研究的条件。这项研究将包括对脑干胶质瘤患者的初始剂量发现阶段(第一阶段)和随后的疗效(第二阶段)部分。主要目标是。1.明确ZD1839联合放射治疗未接受EIACDs治疗的儿童脑干胶质瘤和未完全切除的STMG的安全性。2.确定ZD1839在接受EIACDs治疗的初诊、未完全切除的STMG患儿中的安全性。3.观察ZD1839联合放射治疗儿童脑干胶质瘤的疗效。

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. Children with newly diagnosed intrinsic brain stem gliomas (BSG) and incompletely resected supratentorial malignant gliomas (STMG) with residual tumor on imaging will be eligible for this study. The study will consist of an initial dose finding phase (phase I) component, and a subsequent efficacay (phase II) component for patients with brain stem gliomas. The Primary Objectives are. 1. To define the safety of ZD1839 administered in conjunction with irradiation in children with newly diagnosed brainstem gliomas and incompletely resected STMG not receiving EIACDs. 2. To define the safety of ZD1839 in children with newly diagnosed, incompletely resected STMG receiving EIACDs. 3. To assess the efficacay of ZD1839 given with radiation therapy in children newly diagnosed with poor prognosis brainstem glioma.