CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Imatinib Mesylate +2 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Histologically confirmed grade 2-4 oligodendroglioma or mixed oligoastrocytoma with oligodendrogliomatous component, with diagnosis of recurrence
  • ✓Measurable or evaluable disease by MRI or CT scan
  • ✓Must have failed surgery/radiotherapy and temozolomide or nitrosourea-based therapy
  • ✓Unequivocal evidence of tumor progression by MRI or CT within 21 days prior to registration
Key exclusion· 7
  • ✕Receiving warfarin or heparin
  • ✕Prior stereotactic radiosurgery, interstitial brachytherapy, or interstitial chemotherapy including BCNU wafers unless separate lesion outside treatment field
  • ✕Active uncontrolled infection
  • ✕History of myocardial infarction within 6 months or CHF requiring ongoing maintenance therapy for life-threatening arrhythmias; NYHA class III or IV

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00049127
NCT00049127Phase 2Completed
CompareCT.gov

Phase I/II Trial of Imatinib Mesylate; (Gleevec; STI571) in Treatment of Recurrent Oligodendroglioma and Mixed Oligoastrocytoma

Alliance for Clinical Trials in Oncology·interventional·Posted Jan 27, 2003·Updated Oct 21, 2019

In Brief

A Phase 2 clinical trial evaluating Imatinib Mesylate, Laboratory Biomarker Analysis, and 1 other intervention for Adult Anaplastic Oligodendroglioma and 3 related conditions. Completed, enrolled 64 participants across 229 sites.

Detailed Summary

This phase I/II trial is studying the side effects and best dose of imatinib mesylate and to see how well it works in treating patients with a recurrent brain tumor that has not responded to previous surgery and radiation therapy. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Anaplastic Oligodendroglioma, Adult Mixed Glioma, Adult Oligodendroglioma, Recurrent Adult Brain Neoplasm
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJun 1, 2003
Primary CompletionAug 1, 2011
Study CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 23.4 years ago

Interventions

Imatinib Mesylatedrug

Given PO

Laboratory Biomarker Analysisother

Optional correlative studies

Pharmacological Studyother

Optional correlative studies