Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma
Phase I/II Trial of STI571 (NSC 716051) in Patients With Recurrent Malignant Gliomas
NCT00010049CI-TRIAL-00033454completedPhase 1 / Phase 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 may be an effective treatment for recurrent glioma and meningioma. PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, recurrent, or unresectable malignant glioma or meningioma.
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
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or unresectable malignant glioma * Glioblastoma multiforme (phase I only) * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Malignant astrocytoma not otherwise specified * Gliosarcoma * Low-grade histology with subsequent diagnosis of malignant glioma allowed (phase I only) OR * Histologically confirmed recurrent or unresectable benign or malignant meningioma (phase I only) * No prior intracranial hemorrhage * Failed prior radiotherapy * Progressive or recurrent disease by MRI or CT scan and/or resection * PET or thallium scan, MR spectroscopy, or surgical documentation required in patients who have received prior interstitial brachytherapy or stereotactic radiosurgery * Stable dose of steroids for 5-7 days prior to MRI or CT scan PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 8 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: * Bilirubin less than 2 times upper limit of normal (ULN) * SGOT less than 2 times ULN * No significant hepatic disease Renal: * Creatinine less than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * No significant renal disease Cardiovascular: * No significant cardiac disease * No deep venous or arterial thrombosis within the past 6 weeks Pulmonary: * No pulmonary embolism within the past 6 weeks Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for up to 6 months after study participation * No other serious concurrent medical illness * No serious active infection * No concurrent disease that would obscure toxicity or alter drug metabolism * No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior interferon or thalidomide and recovered * No concurrent immunotherapy * No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: * Recovered from prior chemotherapy * At least 4 weeks since prior cytotoxic therapy * At least 2 weeks since prior vincristine * At least 6 weeks since prior nitrosoureas * At least 4 weeks since prior temozolomide * At least 3 weeks since prior procarbazine * Prior polifeprosan 20 with carmustine implant (Gliadel wafer) allowed * Prior radiosensitizers allowed * No other concurrent chemotherapy * Phase I only: * Prior chemotherapy required for anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic mixed oligoastrocytoma * Prior treatment for up to 3 relapses allowed * Phase II only: * Prior chemotherapy not required * Prior treatment for up to 2 relapses allowed Endocrine therapy: * See Disease Characteristics * At least 1 week since prior tamoxifen and recovered * No concurrent anticancer hormonal therapy Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics * Recovered from prior surgical resection of recurrent or progressive disease Other: * At least 1 week since prior non-cytotoxic agents and recovered * At least 1 week since prior tretinoin and recovered * At least 2 weeks since prior drugs that affect hepatic metabolism * No other concurrent investigational agents * No concurrent warfarin
References
Publications (2)
- RESULTWen PY, Yung WK, Lamborn KR, Dahia PL, Wang Y, Peng B, Abrey LE, Raizer J, Cloughesy TF, Fink K, Gilbert M, Chang S, Junck L, Schiff D, Lieberman F, Fine HA, Mehta M, Robins HI, DeAngelis LM, Groves MD, Puduvalli VK, Levin V, Conrad C, Maher EA, Aldape K, Hayes M, Letvak L, Egorin MJ, Capdeville R, Kaplan R, Murgo AJ, Stiles C, Prados MD. Phase I/II study of imatinib mesylate for recurrent malignant gliomas: North American Brain Tumor Consortium Study 99-08. Clin Cancer Res. 2006 Aug 15;12(16):4899-907. doi: 10.1158/1078-0432.CCR-06-0773. PMID 16914578
- RESULTWen PY, Yung WKA, Lamborn K, et al.: Phase I/II study of imatinib mesylate (ST1571) for patients with recurrent malignant gliomas (NABTC 99-08). [Abstract] Neuro-Oncology 6 (4): TA-63, 385, 2004.