Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Recurrent Meningioma
Phase II Trial of STI571 (NSC 716051) in Patients With Recurrent Meningioma
NCT00045734CI-TRIAL-00027554completedPhase 2Results postedClinicalTrials.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)
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent meningioma. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Grade III Meningioma | Adult Grade 3 Meningioma | ALIAS | 0.90 |
| Adult Grade II Meningioma | Adult Grade 2 Meningioma | ALIAS | 0.90 |
| Adult Grade I Meningioma | Adult Grade 1 Meningioma | ALIAS | 0.90 |
| Adult Meningeal Hemangiopericytoma | Meningeal Solitary Fibrous Tumor | ALIAS | 0.85 |
| Adult Meningioma | Adult Meningioma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Adult Brain Tumor | Adult Brain Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (imatinib mesylate)
- description
- Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study/ laboratory biomarker analysis
- interventionNames
- Drug: imatinib mesylate
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- 6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria
- timeFrame
- At 6 months
- description
- The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (magnetic resonance imaging \[MRI\]) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed meningioma * Benign, malignant, or atypical disease * Neurofibromatosis (NF) type 1 or 2 allowed * Hemangiopericytoma allowed * Unequivocal evidence of tumor recurrence or progression by MRI or CT scan (on steroid dosage that is stable for at least 5 days) * Evaluable residual disease by MRI or CT scan if previously treated with surgical resection for recurrent or progressive disease * Newly diagnosed recurrent disease that requires surgical debulking allowed * Prior standard external-beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery allowed provided disease has progressed since completion of therapy * Patients who have had prior brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon positron-emission tomography or thallium scanning, magnetic resonance spectroscopy, or surgical documentation * Patients with a history of NF may have other stable Central Nervous System (CNS) tumors (e.g., schwannoma, acoustic neuroma, or ependymoma) provided those lesions have been stable in size for the past 6 months * Performance status - Karnofsky 60-100% * More than 8 weeks * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 120,000/mm\^3 * Hemoglobin at least 10 g/dL (transfusions allowed) * No bleeding disorders * Bilirubin less than 2 times upper limit of normal (ULN) * Serum glutamic oxaloacetic transaminase (SGOT) less than 2 times ULN * Prothrombin Time (PT), Partial thromboplastin time (PTT), and International normalized Ratio (INR) no greater than 1.5 times ULN * Creatinine less than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * No deep venous or arterial thrombosis within the past 6 weeks * No pulmonary embolism within the past 6 weeks * No serious active infection * No prior intracranial hemorrhage * No concurrent disease that would obscure toxicity or dangerously alter drug metabolism * No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless the patient is in complete remission and off all therapy for that disease for at least 3 years * No other significant medical illness that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 3 months after study participation * At least 1 week since prior interferon or thalidomide * No concurrent immunotherapy * Concurrent epoetin alfa allowed * At least 4 weeks since prior cytotoxic chemotherapy * At least 2 weeks since prior vincristine * At least 6 weeks since prior nitrosoureas * At least 3 weeks since prior hydroxyurea or procarbazine * No concurrent chemotherapy * At least 1 week since prior tamoxifen * No concurrent hormonal therapy * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy * Recovered from prior surgery * Recovered from all prior therapy * At least 1 week since prior noncytotoxic therapy (e.g., isotretinoin) except radiosensitizers * At least 2 weeks since prior drugs that affect hepatic metabolism * At least 4 weeks since prior investigational agents * No concurrent warfarin (heparin or low-molecular weight heparin allowed) * No other concurrent investigational agents * No concurrent acetaminophen of more than 500 mg/day * No other concurrent anticancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.