Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)

Overall Status

Completed

CT.gov ID

NCT00401024

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: imatinib mesylate Other: pharmacological study Procedure: conventional surgery	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 12, 2006

Actual Primary Completion Date :

Feb 4, 2008

Actual Study Completion Date :

Nov 11, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment 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 Other: pharmacological study Procedure: conventional surgery

Arm

Intervention/Treatment

Experimental: Treatment

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

Other: pharmacological study

Procedure: conventional surgery

Outcome Measures

Primary Outcome Measures

Tumor:plasma concentration ratio of imatinib mesylate [2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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