Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

Study Overview
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Brief Summary
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RATIONALE: Collecting samples of tumor tissue and blood from patients with cancer to study in the laboratory may help doctors learn how patients respond to treatment. PURPOSE: This clinical trial is looking at tumor tissue samples from patients receiving imatinib mesylate for malignant glioma to see how much imatinib mesylate is found in the tumor tissue.

Detailed Description
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OBJECTIVES: Primary Determine the efficacy, of imatinib mesylate, in terms of achieving a therapeutic tumor:plasma concentration ratio, in patients with primary malignant glioma. Secondary Correlate tumor grade (low vs high) and/or tumor enhancement on MRI with tumor concentration of this drug in these patients., OUTLINE: Patients receive oral imatinib mesylate once daily for 7-12 days. Patients then undergo surgical resection. Blood and tissue samples are collected at the time of surgery and analyzed for imatinib mesylate concentration. After completion of study treatment, patients are followed for 7 days. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Official Title
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Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: imatinib mesylate
* Other: pharmacological study
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma of 1 of the following subtypes: Low-grade glioma Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme Unifocal disease that is progressive or recurrent after prior radiotherapy and/or chemotherapy Scheduled to undergo surgical resection Able to undergo maximal surgical resection of tumor mass PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% Mini Mental Status Exam ≥ 15 Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Creatinine ≥ 1.7 mg/dL BUN ≤ 2 times upper limit of normal (ULN) Transaminases ≤ 4 times ULN Not pregnant or nursing Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment No other medical illness that would preclude study treatment, including any of the following: Serious infection Uncontrolled hypertension Unstable angina pectoris Uncontrolled cardiac dysrhythmia PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from all prior therapy At least 4 weeks since prior investigational drugs No more than 1 prior chemotherapy regimen No concurrent chemotherapy, biologic therapy, or radiotherapy No concurrent medications that may interact with imatinib mesylate or interfere with hepatic cytochrome P450 system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Imatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery | Drug: imatinib mesylate<br> <br> Other: pharmacological study<br> <br> Procedure: conventional surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor:plasma concentration ratio of imatinib mesylate |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult anaplastic oligodendroglioma, adult oligodendroglioma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma, recurrent adult brain tumor, adult brain stem glioma, adult mixed glioma, adult glioblastoma, adult pilocytic astrocytoma, adult diffuse astrocytoma, adult anaplastic ependymoma, adult ependymoma, adult myxopapillary ependymoma, adult subependymoma, adult pineal gland astrocytoma, adult subependymal giant cell astrocytoma