Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma
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.
Brain and Central Nervous System Tumors
Drug: imatinib mesylate
Other: pharmacological study
Procedure: conventional surgery
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration|
- Tumor:plasma concentration ratio of imatinib mesylate [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
- Determine the efficacy, of imatinib mesylate, in terms of achieving a therapeutic tumor:plasma concentration ratio, in patients with primary malignant glioma.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401024
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Stuart A. Grossman, MD||Sidney Kimmel Comprehensive Cancer Center|