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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00039364 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: imatinib mesylate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas |
| Study Start Date: | March 2002 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed glioblastoma multiforme
Histologically or cytologically confirmed anaplastic oligodendroglioma, mixed oligoastrocytoma, anaplastic astrocytoma, or recurrent low-grade astrocytoma
No more than 1 prior chemotherapy regimen
At least 1 bidimensionally measurable target lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Prior surgery for primary brain tumor within the past 3 months allowed provided one of the following conditions are present:
Other:
Contacts and Locations| Austria | |
| Kaiser Franz Josef Hospital | |
| Vienna, Austria, A-1100 | |
| Belgium | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| France | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| Centre de Lutte Contre le Cancer, Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| CRLCC Nantes - Atlantique | |
| Nantes-Saint Herblain, France, 44805 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Italy | |
| Azienda Ospedaliera di Padova | |
| Padova, Italy, 35100 | |
| Netherlands | |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
| Rotterdam, Netherlands, 3008 AE | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| United Kingdom, Scotland | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Investigator: | Eric Raymond, MD, PhD | Institut Gustave Roussy |
| Investigator: | Martin J. van Den Bent, MD | Daniel Den Hoed Cancer Center at Erasmus Medical Center |
More Information
| Study ID Numbers: | CDR0000069377, EORTC-16011, EORTC-26013 |
| Study First Received: | June 6, 2002 |
| Last Updated: | November 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00039364 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult mixed glioma |
adult pilocytic astrocytoma adult subependymoma adult giant cell glioblastoma adult gliosarcoma adult diffuse astrocytoma |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Enzyme Inhibitors Central Nervous System Neoplasms Protein Kinase Inhibitors Pharmacologic Actions Imatinib |
Neuroectodermal Tumors Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |