Study Results
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Basic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2002-03-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas.
Detailed Description
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* 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
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Keywords
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Study Design
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TREATMENT
Interventions
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imatinib mesylate
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed glioblastoma multiforme
* Recurrent disease by CT scan or MRI
* No prior chemotherapy OR
* No more than 1 prior chemotherapy regimen in adjuvant setting or for recurrent disease OR
* Histologically or cytologically confirmed anaplastic oligodendroglioma, mixed oligoastrocytoma, anaplastic astrocytoma, or recurrent low-grade astrocytoma
* Failed prior radiotherapy
* No more than 1 prior chemotherapy regimen
* Failed adjuvant chemotherapy OR
* Failed first-line chemotherapy
* At least 1 bidimensionally measurable target lesion
* At least 2 cm on contrast-enhanced CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
Renal:
* Creatinine less than 1.7 mg/dL
Cardiovascular:
* Cardiac function normal
* No ischemic heart disease within the past 6 months
* Normal 12-lead ECG
Other:
* No other prior or concurrent malignancy except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer
* No unstable systemic disease
* No active uncontrolled infection
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent anticancer biologic agents
* No concurrent cytokines (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea)
* No concurrent chemotherapy
Endocrine therapy:
* Must be on stable or decreasing dose of corticosteroids for at least 2 weeks
Radiotherapy:
* See Disease Characteristics
* At least 3 months since prior brain irradiation
* No prior high-dose radiotherapy (more than 65 Gy), stereotactic radiosurgery, or internal radiotherapy unless the recurrence is histologically confirmed
* No concurrent radiotherapy
Surgery:
* Prior surgery for primary brain tumor within the past 3 months allowed provided one of the following conditions are present:
* Postoperative imaging within 72 hours after surgery shows a clearly limited target lesion of at least 2 cm
* Postoperative follow-up shows a progressive and measurable target lesion
* A second measurable target lesion is present outside the surgical area
Other:
* No concurrent warfarin or other anticoagulants
* No other concurrent anticancer agents
* No other concurrent investigational agents
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Eric Raymond, MD, PhD
Role: STUDY_CHAIR
Gustave Roussy, Cancer Campus, Grand Paris
Martin J. van Den Bent, MD
Role: STUDY_CHAIR
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Locations
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Kaiser Franz Josef Hospital
Vienna, , Austria
U.Z. Gasthuisberg
Leuven, , Belgium
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, , France
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, , France
Centre Antoine Lacassagne
Nice, , France
Institut Gustave Roussy
Villejuif, , France
Azienda Ospedaliera di Padova
Padua, , Italy
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, , Netherlands
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom
Countries
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References
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Raymond E, Brandes AA, Dittrich C, Fumoleau P, Coudert B, Clement PM, Frenay M, Rampling R, Stupp R, Kros JM, Heinrich MC, Gorlia T, Lacombe D, van den Bent MJ; European Organisation for Research and Treatment of Cancer Brain Tumor Group Study. Phase II study of imatinib in patients with recurrent gliomas of various histologies: a European Organisation for Research and Treatment of Cancer Brain Tumor Group Study. J Clin Oncol. 2008 Oct 1;26(28):4659-65. doi: 10.1200/JCO.2008.16.9235.
Raymond E, Brandes A, Van Oosterom A, et al.: Multicentre phase II study of imatinib mesylate in patients with recurrent glioblastoma: an EORTC: NDDG/BTG Intergroup study. [Abstract] J Clin Oncol 22 (Suppl 14): A-1501, 2004.
Other Identifiers
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EORTC-16011
Identifier Type: -
Identifier Source: secondary_id
EORTC-26013
Identifier Type: -
Identifier Source: secondary_id
EORTC-16011-26013
Identifier Type: -
Identifier Source: org_study_id