Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Gliomas
Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas
NCT00039364CI-TRIAL-00007533completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* 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 agentsReferences
Publications (2)
- RESULTRaymond 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. PMID 18824712
- RESULTRaymond 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.