Clinical trial · Interventional
Imatinib Mesylate With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed or Recurrent Glioma
A Phase I/II Trial Of STI571 In Children With Newly Diagnosed Poor Prognosis Brainstem Gliomas And Recurrent Intracranial Malignant Gliomas
NCT00021229CI-TRIAL-00015264terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
Phase I/II trial to estimate the maximum tolerated dose of imatinib mesylate in newly diagnosed brain stem gliomas and recurrent high grade gliomas and to assess the effectiveness of imatinib mesylate in treating young patients who have newly diagnosed intrinsic brain stem glioma. Imatinib mesylate may interfere with the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining imatinib mesylate with radiation therapy may kill more tumor cells.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| local irradiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imatinib mesylate
- interventionNames
- Drug: imatinib mesylate
- Radiation: local irradiation therapy
Primary outcomes (3)
- measure
- Number of Participants in Phase I Stratum I With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy
- timeFrame
- Day 1 of Imatinib Mesylate Therapy to Week 8
- description
- The dose limiting toxicity (DLT) analysis population consists of phase I stratum I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (course 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD. The estimated MTD based on the 23 participants who either had a DLT during course 1 or 2 or completed courses 1 and 2 without DLT is 265 mg/m2/day.
- measure
- Number of Participants in Phase I Stratum II With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria * Age 3 to 21 * Performance status of Karnofsky 50-100% OR Lansky 50-100% * Absolute neutrophil count greater than 1,000/mm3 * Platelet count greater than 100,000/mm3 (transfusion independent) * Hemoglobin greater than 8 g/dL (transfusion allowed) * Bilirubin no greater than 1.5 times normal for age * SGPT less than 3 times normal for age * Albumin at least 2 g/dL * Creatinine less than 1.5 times normal for age OR Glomerular filtration rate greater than 70 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 6 months after study participation * Stratum I * Newly diagnosed diffuse intrinsic brainstem malignant glioma * No disseminated disease * No radiographic evidence of intratumoral hemorrhage before or during radiotherapy * No prior chemotherapy (beyond routine corticosteroids) * No prior irradiation * Must not be receiving enzyme-inducing anticonvulsant drugs * Stratum II * Histologically confirmed recurrent or refractory anaplastic astrocytoma, glioblastoma multiforme, or other high-grade glioma (including recurrent brain stem glioma * No intratumoral hemorrhage unrelated to prior surgical procedure * No myelosuppressive chemotherapy within 3 weeks (6 weeks if a nitrosourea agent) of study entry * No prior imatinib mesylate * At least 3 months since prior craniospinal radiotherapy (18 Gy or more) * At least 8 weeks since prior local radiotherapy to primary tumor * At least 2 weeks since prior focal radiotherapy for symptomatic * At least 3 months since prior bone marrow transplantation * Neurological deficits allowed if stable for at least 1 week prior to study Exclusion Criteria * Receiving other anticancer or experimental drug therapy. * Ongoing uncontrolled infection. * Significant cardiac, hepatic, gastrointestinal, renal, pulmonary, or psychiatric disease. * Deep venous or arterial thrombosis within 6 weeks of registration. * Taking warfarin. * Newly diagnosed diffuse intrinsic brainstem malignant glioma with disseminated disease (stratum I) * Intratumoral hemorrhage
References
Publications (2)
- RESULTWilliams G, Fahey FH, Treves ST, Kocak M, Pollack IF, Boyett JM, Kun LE, Poussaint TY. Exploratory evaluation of two-dimensional and three-dimensional methods of FDG PET quantification in pediatric anaplastic astrocytoma: a report from the Pediatric Brain Tumor Consortium (PBTC). Eur J Nucl Med Mol Imaging. 2008 Sep;35(9):1651-8. doi: 10.1007/s00259-008-0780-7. Epub 2008 Apr 19. PMID 18425516
- RESULTPollack IF, Jakacki RI, Blaney SM, Hancock ML, Kieran MW, Phillips P, Kun LE, Friedman H, Packer R, Banerjee A, Geyer JR, Goldman S, Poussaint TY, Krasin MJ, Wang Y, Hayes M, Murgo A, Weiner S, Boyett JM. Phase I trial of imatinib in children with newly diagnosed brainstem and recurrent malignant gliomas: a Pediatric Brain Tumor Consortium report. Neuro Oncol. 2007 Apr;9(2):145-60. doi: 10.1215/15228517-2006-031. Epub 2007 Feb 9. PMID 17293590