Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Imatinib Mesylate in Treating Patients With Recurrent Meningioma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI NABTC-0108 NCI-03-C-0311, NCT00045734, NABTC-01-08

Objectives

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

Entry 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

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

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/mm³
• Platelet count at least 120,000/mm³
• 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

Expected Enrollment

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

Outcomes

6-month progression-free survival

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.

Trial Contact Information

Trial Lead Organizations

North American Brain Tumor Consortium

Patrick Wen, MD, Protocol chair		Ph: 617-632-2166; 866-790-4500 Email: patrick_wen@dfci.harvard.edu

Registry Information
Official Title		Phase II Trial of STI571 (NSC 716051) in Patients with Recurrent Meningioma
Trial Start Date		2003-02-05
Trial Completion Date		2008-11-11
Registered in ClinicalTrials.gov		NCT00045734
Date Submitted to PDQ		2002-07-25
Information Last Verified		2005-11-29
NCI Grant/Contract Number		CA62399

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