NCT00045734

Imatinib Mesylate in Treating Patients With Recurrent Meningioma

Phase II Trial of STI571 (NSC 716051) in Patients With Recurrent Meningioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	imatinib mesylate	Given orally
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2003-02-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2003-01-27
• Last updated: 2017-05-15
• Results posted: 2017-05-15

Locations

7 sites across 1 country: United States