Imatinib Mesylate in Treating Patients With Gliomas
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|ClinicalTrials.gov Identifier: NCT00039364|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: imatinib mesylate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Official Title:||Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas|
|Study Start Date :||March 2002|
|Actual Primary Completion Date :||August 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039364
|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|