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Imatinib Mesylate in Treating Patients With Recurrent Meningioma
This study has been completed.
First Received: September 6, 2002   Last Updated: March 24, 2009   History of Changes
Sponsor: North American Brain Tumor Consortium
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045734
  Purpose

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent meningioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: imatinib mesylate
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of STI571 (NSC 716051) in Patients With Recurrent Meningioma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 6-month progression-free survival [ Designated as safety issue: No ]

Study Start Date: February 2003
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of imatinib mesylate, in terms of 6-month progression-free survival, of patients with recurrent meningioma.
  • Determine the response rate and overall survival of patients treated with this drug.
  • Evaluate the safety profile of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the surrogate endpoints of angiogenic activity of this drug in these patients.
  • Correlate 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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 CNS tumors (e.g., schwannoma, acoustic neuroma, or ependymoma) provided those lesions have been stable in size for the past 6 months

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 8 weeks

Hematopoietic

  • 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

Hepatic

  • Bilirubin less than 2 times upper limit of normal (ULN)
  • SGOT less than 2 times ULN
  • PT, PTT, and INR no greater than 1.5 times ULN

Renal

  • Creatinine less than 1.5 mg/dL AND/OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular

  • No deep venous or arterial thrombosis within the past 6 weeks

Pulmonary

  • No pulmonary embolism within the past 6 weeks

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 1 week since prior interferon or thalidomide
  • No concurrent immunotherapy
  • Concurrent epoetin alfa allowed

Chemotherapy

  • 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

Endocrine therapy

  • See Disease Characteristics
  • At least 1 week since prior tamoxifen
  • No concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045734

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143-0372
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0316
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-9154
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-6220
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
North American Brain Tumor Consortium
Investigators
Study Chair: Patrick Y. Wen, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000257267, NABTC-0108, NCI-03-C-0311
Study First Received: September 6, 2002
Last Updated: March 24, 2009
ClinicalTrials.gov Identifier: NCT00045734     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult meningioma
recurrent adult brain tumor
adult grade III meningioma
adult grade I meningioma
adult grade II meningioma
adult meningeal hemangiopericytoma

Additional relevant MeSH terms:
Meningeal Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Nervous System Diseases
Enzyme Inhibitors
Central Nervous System Neoplasms
Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib
Neoplasms
Neoplasms by Site
Therapeutic Uses
Neoplasms, Vascular Tissue
Meningioma
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009