Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors
• Interventions: Drug: imatinib mesylate; Other: pharmacological study; Procedure: conventional surgery

• Registration Number: NCT00401024
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.

Study Timeline

• Study Start: 2006-10-12
• Study First Submitted: 2006-11-16
• Study First Submitted QC: 2006-11-16
• Study First Posted: 2006-11-17
• Primary Completion: 2008-02-04
• Study Completion: 2008-11-11
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	pharmacological study	Imatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery
Treatment	imatinib mesylate	Imatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery
Treatment	conventional surgery	Imatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery

Primary Outcome Measures

Name	Time	Method
Tumor:plasma concentration ratio of imatinib mesylate	2 weeks

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States