Clinical trial · Interventional
Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma
Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration
NCT00401024CI-TRIAL-00033513completedPhase 1ClinicalTrials.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: Collecting samples of tumor tissue and blood from patients with cancer to study in the laboratory may help doctors learn how patients respond to treatment. PURPOSE: This clinical trial is looking at tumor tissue samples from patients receiving imatinib mesylate for malignant glioma to see how much imatinib mesylate is found in the tumor tissue.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Imatinib mesylate 600mg orally once a day for seven consecutive days prior to surgery with last dose taken one day prior to surgery
- interventionNames
- Drug: imatinib mesylate
- Other: pharmacological study
- Procedure: conventional surgery
Primary outcomes (1)
- measure
- Tumor:plasma concentration ratio of imatinib mesylate
- timeFrame
- 2 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioma of 1 of the following subtypes: * Low-grade glioma * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Glioblastoma multiforme * Unifocal disease that is progressive or recurrent after prior radiotherapy and/or chemotherapy * Scheduled to undergo surgical resection * Able to undergo maximal surgical resection of tumor mass PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Mini Mental Status Exam ≥ 15 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≥ 1.7 mg/dL * BUN ≤ 2 times upper limit of normal (ULN) * Transaminases ≤ 4 times ULN * Not pregnant or nursing * Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment * No other medical illness that would preclude study treatment, including any of the following: * Serious infection * Uncontrolled hypertension * Unstable angina pectoris * Uncontrolled cardiac dysrhythmia PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from all prior therapy * At least 4 weeks since prior investigational drugs * No more than 1 prior chemotherapy regimen * No concurrent chemotherapy, biologic therapy, or radiotherapy * No concurrent medications that may interact with imatinib mesylate or interfere with hepatic cytochrome P450 system
References
Publications (1)
- RESULTHoldhoff M, Supko JG, Gallia GL, Hann CL, Bonekamp D, Ye X, Cao B, Olivi A, Grossman SA. Intratumoral concentrations of imatinib after oral administration in patients with glioblastoma multiforme. J Neurooncol. 2010 Apr;97(2):241-5. doi: 10.1007/s11060-009-0008-0. Epub 2009 Sep 19. PMID 19768386