Ph I Zactima + Imatinib Mesylate & Hydroxyurea for Pts w Recurrent Malignant Glioma
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
Primary Objective To determine maximum tolerated dose & dose limiting toxicity of Zactima
when combined w standard dosing of imatinib mesylate & hydroxyurea among pts w recurrent
malignant glioma who are on & not on enzyme-inducing anti-epileptic drugs Secondary
Objectives To assess safety & tolerability of Zactima + imatinib mesylate & hydroxyurea To
evaluate pharmacokinetics of Zactima among MG pts on & not on enzyme inducing anti-epileptic
drugs (EIAEDs) when combo w imatinib mesylate & hydroxyurea To evaluate pharmacokinetics of
imatinib mesylate among MG pts on & not on EIAEDs when combo w Zactima & hydroxyurea
Exploratory Objective To evaluate for evidence of anti-tumor activity of study regimen among
recurrent malignant glioma (RMG) pts including radiographic response rate, 6-month
progression free survival (PFS) rate & median PFS