A Phase 1/2 interventional study of imatinib mesylate in Brain and Central Nervous System Tumors, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Completed at 11 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-06-27.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 1/2, Interventional, and Treatment
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.
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to concurrent enzyme-inducing anti-epileptic drug use (yes [stratum closed to accrual as of 05/15/2003 for phase I and phase II] vs no).
Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of the study within 6 months and a total of 39 patients will be accrued for phase II of the study within 6-8 months. (Glioblastoma multiforme patients excluded from phase II as of 05/13/2003).
684 studies on the registry are indexed under Central Nervous System Neoplasms; 68 are open to participants now.
This study's enrollment of 105 is above the median of 35 across 474 interventional studies indexed under Central Nervous System Neoplasms.
Browse Central Nervous System Neoplasms studies →Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 582 studies on the registry; 72 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 67 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed recurrent or unresectable malignant glioma
Progressive or recurrent disease by MRI or CT scan and/or resection
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Phase I only:
Phase II only:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Ran from Feb 2001 to primary completion in Mar 2005, 48 months.
Of 33 phase 1/2 interventional studies under Central Nervous System Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 53 and three quarters within 85. This study's 48 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Imatinib
Central Nervous System Neoplasms →
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins →