Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

PRIMARY OBJECTIVES: I. To identify the maximum tolerated dose of ZD 1839 (gefitinib) when given concurrently with cranial radiotherapy. II. To determine if ZD 1839, given orally on a daily basis starting at the time of conventional radiation therapy (RT), may improve the overall survival of adults with newly-diagnosed supratentorial glioblastoma multiforme, compared with historical controls, stratifying by epidermal growth factor receptor (EGFR) status. III. To determine, in a multi-institutional setting, the feasibility and toxicity of prescribing ZD 1839. SECONDARY OBJECTIVES: I. Whether ZD 1839 also improves progression-free survival in these patients. OUTLINE: This is a phase I, dose-escalation study of gefitinib followed by a phase II study. Patients receive gefitinib orally (PO) once daily (QD) for 7 weeks. Beginning 1 week after initiation of gefitinib, patients undergo radiation therapy QD 5 days a week for 6 weeks. Treatment with gefitinib continues for up to 18 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 2 years, and annually thereafter.