Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401024
• Other study ID #: J0623
• Secondary ID: P30CA006973CDR00
• Status: Completed
• Phase: Phase 1
• Start date: October 12, 2006
• Est. completion date: November 11, 2008

Study information

• Verified date: June 2018
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: November 11, 2008
• Est. primary completion date: February 4, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioma
• Nervous System Neoplasms

Intervention

Drug:
• imatinib mesylate

Other:
• pharmacological study

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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/s11060-00 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor:plasma concentration ratio of imatinib mesylate		2 weeks