Imatinib Mesylate in Treating Patients With Recurrent Meningioma

NCT ID: NCT00045734

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2009-12-31

Brief Summary

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

Detailed Description

PRIMARY OBJECTIVE:

I. Determine the efficacy of imatinib mesylate, in terms of 6-month progression-free survival, of patients with recurrent meningioma.

SECONDARY OBJECTIVES I. Determine the response rate and overall survival of patients treated with this drug.

II. Evaluate the safety profile of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Develop exploratory data concerning surrogate markers of of angiogenic activity in vivo using functional neuro-imaging studies and in vitro assays of serum angiogenic peptides of this drug in these patients.

V. Develop exploratory data concerning evidence of platelet-derived growth factor (PDGF) inhibition in tumor specimens taken from patients undergoing surgery VI. Develop exploratory data correlating molecular abnormalities in the tumor with response in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to concurrent use of enzyme-inducing antiepileptic drugs (yes vs no), histology (benign vs atypical or malignant), neurofibromatosis positivity (yes vs no), and preoperative candidacy (yes vs no).

Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 8-12 months.

Conditions

Adult Grade I Meningioma; Adult Grade II Meningioma; Adult Grade III Meningioma; Adult Meningeal Hemangiopericytoma; Adult Meningioma; Recurrent Adult Brain Tumor

Study Design

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

Study Groups

Treatment (imatinib mesylate)

Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study/ laboratory biomarker analysis

Group Type: EXPERIMENTAL

imatinib mesylate

Intervention Type: DRUG

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

pharmacological study

Intervention Type: OTHER

Correlative studies

Interventions

imatinib mesylate

Given orally

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

pharmacological study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

CGP 57148; Gleevec; Glivec; pharmacological studies

Eligibility Criteria

Inclusion Criteria

• 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
• No concurrent disease that would obscure toxicity or dangerously alter drug metabolism
• No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless the patient is in complete remission and off all therapy for that disease for at least 3 years
• No other significant medical illness that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 3 months after study participation
• At least 1 week since prior interferon or thalidomide
• No concurrent immunotherapy
• Concurrent epoetin alfa allowed
• At least 4 weeks since prior cytotoxic chemotherapy
• At least 2 weeks since prior vincristine
• At least 6 weeks since prior nitrosoureas
• At least 3 weeks since prior hydroxyurea or procarbazine
• No concurrent chemotherapy
• At least 1 week since prior tamoxifen
• No concurrent hormonal therapy
• At least 4 weeks since prior radiotherapy
• No concurrent radiotherapy
• Recovered from prior surgery
• Recovered from all prior therapy
• At least 1 week since prior noncytotoxic therapy (e.g., isotretinoin) except radiosensitizers
• At least 2 weeks since prior drugs that affect hepatic metabolism
• At least 4 weeks since prior investigational agents
• No concurrent warfarin (heparin or low-molecular weight heparin allowed)
• No other concurrent investigational agents
• No concurrent acetaminophen of more than 500 mg/day
• No other concurrent anticancer therapy

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Wen, MD

Role: PRINCIPAL_INVESTIGATOR

North American Brain Tumor Consortium

Locations

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

Countries

United States

Other Identifiers

NABTC-0108

Identifier Type: -

Identifier Source: secondary_id

U01CA062399

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000257267

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCT00069667

Identifier Type: -

Identifier Source: nct_alias

NCI-2012-02495

Identifier Type: -

Identifier Source: org_study_id