imatinib mesylate in treating patients with gliomas

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: imatinib mesylate may interfere with the growth of tumor cells and slow the growth of the tumor. purpose: phase ii trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas.

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 anaplastic oligodendroglioma or mixed oligoastrocytoma vs 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.

Eligibility criteria:
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

Keywords: recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult mixed glioma adult pilocytic astrocytoma adult subependymoma adult giant cell glioblastoma adult gliosarcoma adult diffuse astrocytoma