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: 7608340
• 负责人: TOBEY J. MACDONALD
• 金额: $ 0.03万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608340
• 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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 新诊断的内源性脑干胶质瘤（BSG）和未完全切除的幕上恶性胶质瘤（STMG）且影像学上有残留肿瘤的儿童将有资格参加本研究。 该研究将包括针对脑干胶质瘤患者的初始剂量探索阶段（第一阶段）部分和随后的疗效（第二阶段）部分。主要目标是。 1. 确定 ZD1839 联合放射治疗对于新诊断的脑干胶质瘤和未完全切除 STMG 且未接受 EIACD 的儿童的安全性。 2. 确定 ZD1839 对于新诊断、未完全切除 STMG 并接受 EIACD 的儿童的安全性。 3.评估ZD1839联合放射治疗对初诊预后不良的脑干胶质瘤儿童的疗效。