Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Duke University
With
OBJECTIVES: * Determine the maximum tolerated dose and dose-limiting toxicity, if attainable, of imatinib mesylate in combination with temozolomide in patients with malignant glioma. * Characterize the safety and tolerability of imatinib mesylate, including acute and chronic toxicities, in these patients. * Determine the effect of temozolomide on the pharmacokinetics (PK) of imatinib mesylate at each dose level. * Evaluate the impact of enzyme-inducing anti-epileptic drug (EIAED) coadministration on the PK of imatinib mesylate using a population-based PK approach. * Evaluate the antitumor activity of imatinib mesylate plus temozolomide. OUTLINE: This is a dose-escalation study of imatinib mesylate. Patients are stratified according to concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine, fosphenytoin, primidone, oxcarbazepine) (yes vs no). Patients receive oral imatinib mesylate once or twice daily on days 1-8 and oral temozolomide once daily on days 4-8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of patients receive escalating doses of imatinib mesylate until the maximum tolerated dose is determined. On days 1 and 8 of course 1, blood is drawn for pharmacokinetic studies. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
