RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have newly diagnosed glioblastoma multiforme.

OBJECTIVES:

• Determine treatment effectiveness of gefitinib, in terms of response rate, time to progression, survival at 52 weeks, progression-free survival at 6 months, and overall survival, in patients with newly diagnosed glioblastoma multiforme.
• Determine the toxic effects of this drug in these patients.
• Assess fatigue, depression, excessive daytime somnolence, and quality of life in patients treated with this drug.
• Assess individual variation in responses, pharmacokinetic parameters, and/or biological correlates due to genetic differences in enzymes involved in transport, metabolism, and/or mechanism of action of this drug in these patients.
• Determine if the type of epidermal growth factor receptor affects tumor response and outcome in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib daily. Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years.

Patients are followed every 8 weeks until tumor progression and then every 3 months for 5 years and annually for up to 10 years.

Patients removed from study treatment for reasons other than disease progression are followed every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study within 14 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed WHO grade IV astrocytoma (glioblastoma multiforme) or gliosarcoma

  • No WHO grade III anaplastic astrocytoma, oligodendroglioma, or mixed oligoastrocytoma

• Completed standard external beam radiotherapy within the past 2-5 weeks

  • No evidence of tumor progression during radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10.0 g/dL

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST no greater than 3 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• No other active malignancy
• No uncontrolled infection
• No other severe concurrent disease that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy (including polifeprosan 20 with carmustine implant) for this tumor

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• No prior stereotactic radiosurgery or interstitial brachytherapy

Surgery:

• No more than 15 weeks since prior surgery