NCT00401024

Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	imatinib mesylate
OTHER	pharmacological study
PROCEDURE	conventional surgery

Timeline

• Start date: 2006-10-12
• Primary completion: 2008-02-04
• Completion: 2008-11-11
• First posted: 2006-11-17
• Last updated: 2018-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study