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

PBTC 007 V10B- ZD 1839 (易瑞沙) 的 I/II 期试验

• 批准号: 7717153
• 负责人: TOBEY J. MACDONALD
• 金额: $ 0.07万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717153
• 关键词: Brain Stem Glioma; Child; Computer Retrieval of Information on Scientific Projects Database; Dose; Funding; Gefitinib; Grant; Image; Institution; Malignant Glioma; Newly Diagnosed; Patients; Phase; Phase I/II Trial; Radiation therapy; Research; Research Personnel; Resected; Residual Tumors; Resources; Safety; Source; Supratentorial; United States National Institutes of Health; ZD1839 (IRESSA); irradiation; outcome forecast

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.

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。 新诊断的脑干神经胶质瘤（BSG）和影像学检查显示肿瘤残留的幕上恶性胶质瘤（STMG）未完全切除的儿童将有资格参加本研究。 本研究将包括初始剂量探索阶段（I期）部分和针对脑干胶质瘤患者的后续疗效（II期）部分。主要目标是。1.确定ZD 1839联合放疗在新诊断的脑干胶质瘤和未接受EIACD的未完全切除STMG儿童中的安全性。2.确定ZD 1839在接受EIACD的新诊断、不完全切除STMG儿童中的安全性。3.探讨ZD 1839联合放疗治疗儿童脑干胶质瘤的疗效。