Trials / Completed
CompletedNCT00039364
Imatinib Mesylate in Treating Patients With Gliomas
Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas.
Detailed description
OBJECTIVES: * Determine the therapeutic activity of imatinib mesylate (in terms of objective response and progression-free survival at 6 months) in patients with gliomas. * Determine the safety of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to glioma (glioblastoma multiforme vs anaplastic oligodendroglioma or mixed oligoastrocytoma vs anaplastic astrocytoma or recurrent low-grade astrocytoma). Patients receive oral imatinib mesylate once or twice daily. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 6 months and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 77 patients (29 patients with glioblastoma multiforme, 24 patients with anaplastic oligodendroglioma or mixed oligoastrocytoma, and 24 patients with anaplastic astrocytoma or recurrent low-grade astrocytoma) will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | imatinib mesylate |
Timeline
- Start date
- 2002-03-01
- Primary completion
- 2004-08-01
- First posted
- 2003-01-27
- Last updated
- 2012-07-24
Locations
10 sites across 7 countries: Austria, Belgium, France, Italy, Netherlands, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00039364. Inclusion in this directory is not an endorsement.