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

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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.