Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

NCT ID: NCT00401024

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-12
• Study Completion Date: 2008-11-11

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Imatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery

Group Type: EXPERIMENTAL

imatinib mesylate

Intervention Type: DRUG

pharmacological study

Intervention Type: OTHER

conventional surgery

Intervention Type: PROCEDURE

Interventions

imatinib mesylate

Intervention Type: DRUG

pharmacological study

Intervention Type: OTHER

conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart A. Grossman, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

References

Holdhoff M, Supko JG, Gallia GL, Hann CL, Bonekamp D, Ye X, Cao B, Olivi A, Grossman SA. Intratumoral concentrations of imatinib after oral administration in patients with glioblastoma multiforme. J Neurooncol. 2010 Apr;97(2):241-5. doi: 10.1007/s11060-009-0008-0. Epub 2009 Sep 19.

Reference Type: RESULT

PMID: 19768386 (View on PubMed)

Other Identifiers

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000510133

Identifier Type: -

Identifier Source: secondary_id

NA_00001201

Identifier Type: OTHER

Identifier Source: secondary_id

J0623

Identifier Type: -

Identifier Source: org_study_id