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Home > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Recurrent Meningioma  Imatinib Mesylate in Treating Patients With Recurrent Meningioma
Imatinib Mesylate in Treating Patients With Recurrent Meningioma
For Condition: adult anaplastic astrocytoma,adult papillary meningioma,recurrent adult brain tumor,adult brain malignant hemangiopericytoma,adult meningioma
Status: Recruiting
Sponsor(s): North American Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: 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 recurrentmeningioma.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed meningioma - Benign, malignant, or atypical disease - Neurofibromatosis (NF) type 1 or 2 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickWen, Study Chair, Dana-Farber/Harvard Cancer Center
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Minesh Mehta 608-263-8500
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0316
United States
Recruiting Larry Junck 734-936-7910
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9154
United States
Recruiting Karen Fink 214-648-4730
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Frank Lieberman 412-692-2600
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Timothy Cloughesy 310-825-5321
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94143-0372
United States
Recruiting Michael Prados 415-353-2966
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Patrick Wen 617-632-2166
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Lisa DeAngelis 212-639-7123
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78284-6220
United States
Recruiting John Kuhn 210-567-8355
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Wai-Kwan Yung 713-794-1285
Additional Information:
Study ID Numbers: CDR0000257267; NCI-03-C-0311,NABTC-0108
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045734
Other Adult Papillary Meningioma Studies:
1. Imatinib Mesylate in Treating Patients With Recurrent Meningioma
Related Studies:
Other adult papillary meningioma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Imatinib Mesylate in Treating Patients With Recurrent Meningioma
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