Imatinib Mesylate in Treating Patients With Gliomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: imatinib mesylate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: imatinib mesylate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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