Imatinib Mesylate in Treating Patients With Recurrent Meningioma

Completed · Phase 2

Conditions studied: Adult Grade I Meningioma, Adult Grade II Meningioma, Adult Grade III Meningioma, Adult Meningeal Hemangiopericytoma, Adult Meningioma, Recurrent Adult Brain Tumor

In brief

Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent meningioma. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth

Key facts

Study ID

NCT00045734

Run by

National Cancer Institute (NCI)

People needed

23

Starts

2003-02-01

Expected to finish

2009-12-01

Last updated by the study team

2017-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed meningioma
• Benign, malignant, or atypical disease
• Neurofibromatosis (NF) type 1 or 2 allowed
• Hemangiopericytoma allowed
• Unequivocal evidence of tumor recurrence or progression by MRI or CT scan (on steroid dosage that is stable for at least 5 days)
• Evaluable residual disease by MRI or CT scan if previously treated with surgical resection for recurrent or progressive disease
• Newly diagnosed recurrent disease that requires surgical debulking allowed
• Prior standard external-beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery allowed provided disease has progressed since completion of therapy
• Patients who have had prior brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon positron-emission tomography or thallium scanning, magnetic resonance spectroscopy, or surgical documentation
• Patients with a history of NF may have other stable Central Nervous System (CNS) tumors (e.g., schwannoma, acoustic neuroma, or ependymoma) provided those lesions have been stable in size for the past 6 months
• Performance status - Karnofsky 60-100%
• More than 8 weeks
• Absolute neutrophil count at least 2,000/mm\^3
• Platelet count at least 120,000/mm\^3
• Hemoglobin at least 10 g/dL (transfusions allowed)
• No bleeding disorders
• Bilirubin less than 2 times upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) less than 2 times ULN
• Prothrombin Time (PT), Partial thromboplastin time (PTT), and International normalized Ratio (INR) no greater than 1.5 times ULN
• Creatinine less than 1.5 mg/dL
• Creatinine clearance at least 60 mL/min
• No deep venous or arterial thrombosis within the past 6 weeks
• No pulmonary embolism within the past 6 weeks
• No serious active infection
• No prior intracranial hemorrhage

Where it is running

• University of California Los Angeles — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• National Cancer Institute Neuro-Oncology Branch — Bethesda, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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