Clinical Trial Finder

DISEASE CHARACTERISTICS:

• - Histologically or cytologically confirmed glioblastoma multiforme.

• - Recurrent disease by CT scan or MRI.

• - No prior chemotherapy OR.

• - No more than 1 prior chemotherapy regimen in adjuvant setting or for recurrent disease OR.

• - Histologically or cytologically confirmed anaplastic oligodendroglioma, mixed oligoastrocytoma, anaplastic astrocytoma, or recurrent low-grade astrocytoma.

• - Failed prior radiotherapy.

• - No more than 1 prior chemotherapy regimen.

• - Failed adjuvant chemotherapy OR.

• - Failed first-line chemotherapy.

• - At least 1 bidimensionally measurable target lesion.

• - At least 2 cm on contrast-enhanced CT scan or MRI.

PATIENT CHARACTERISTICS: Age:

• - 18 and over.

Performance status:

• - ECOG 0-2.

Life expectancy:

• - Not specified.

Hematopoietic:

• - Neutrophil count at least 2,000/mm^3.

• - Platelet count at least 100,000/mm^3.

Hepatic:

• - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN.

• - Alkaline phosphatase no greater than 2.5 times ULN.

Renal:

• - Creatinine less than 1.7 mg/dL.

Cardiovascular:

• - Cardiac function normal.

• - No ischemic heart disease within the past 6 months.

• - Normal 12-lead ECG.

Other:

• - No other prior or concurrent malignancy except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer.

• - No unstable systemic disease.

• - No active uncontrolled infection.

• - No psychological, familial, sociological, or geographical condition that would preclude study compliance.

• - Not pregnant or nursing.

• - Negative pregnancy test.

• - Fertile patients must use effective contraception during and for 3 months after study.

PRIOR CONCURRENT THERAPY: Biologic therapy:

• - No concurrent anticancer biologic agents.

• - No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) Chemotherapy: - See Disease Characteristics.

• - At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea) - No concurrent chemotherapy.

Endocrine therapy:

• - Must be on stable or decreasing dose of corticosteroids for at least 2 weeks.

Radiotherapy:

• - See Disease Characteristics.

• - At least 3 months since prior brain irradiation.

• - No prior high-dose radiotherapy (more than 65 Gy), stereotactic radiosurgery, or internal radiotherapy unless the recurrence is histologically confirmed.

• - No concurrent radiotherapy.

Surgery:

• - Prior surgery for primary brain tumor within the past 3 months allowed provided one of the following conditions are present: - Postoperative imaging within 72 hours after surgery shows a clearly limited target lesion of at least 2 cm.

• - Postoperative follow-up shows a progressive and measurable target lesion.

• - A second measurable target lesion is present outside the surgical area.

Other:

• - No concurrent warfarin or other anticoagulants.

• - No other concurrent anticancer agents.

- No other concurrent investigational agents

OBJECTIVES:

• - Determine the therapeutic activity of imatinib mesylate (in terms of objective response and progression-free survival at 6 months) in patients with gliomas.

• - Determine the safety of this drug in these patients.

• - Determine the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to glioma (glioblastoma multiforme vs.#46;anaplastic oligodendroglioma or mixed oligoastrocytoma vs.#46; anaplastic astrocytoma or recurrent low-grade astrocytoma). Patients receive oral imatinib mesylate once or twice daily. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 6 months and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 77 patients (29 patients with glioblastoma multiforme, 24 patients with anaplastic oligodendroglioma or mixed oligoastrocytoma, and 24 patients with anaplastic astrocytoma or recurrent low-grade astrocytoma) will be accrued for this study.