Imatinib Mesylate in Treating Patients With Gliomas
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.
Brain and Central Nervous System Tumors
Drug: imatinib mesylate
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas|
|Study Start Date:||March 2002|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
- 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.
|Kaiser Franz Josef Hospital|
|Vienna, Austria, A-1100|
|Leuven, Belgium, B-3000|
|Centre de Lutte Contre le Cancer, Georges-Francois Leclerc|
|Dijon, France, 21079|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Azienda Ospedaliera di Padova|
|Padova, Italy, 35100|
|Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Rotterdam, Netherlands, 3008 AE|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Beatson Oncology Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||Eric Raymond, MD, PhD||Gustave Roussy, Cancer Campus, Grand Paris|
|Study Chair:||Martin J. van Den Bent, MD||Daniel Den Hoed Cancer Center at Erasmus Medical Center|