Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins3 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain and Central Nervous System Tumors

Interventions

imatinib mesylateDRUG

pharmacological studyOTHER

conventional surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Tumor:plasma concentration ratio of imatinib mesylate

Time frame: 2 weeks

Data from ClinicalTrials.gov

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