Ph I Gleevec in Combo w RAD001 + Hydroxyurea for Pts w Recurrent MG
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
Primary objective To determine maximum tolerated dose & dose limiting toxicity of imatinib
mesylate & RAD001 when combined w fixed doses of hydroxyurea among pts w recurrent GBM who
are on & not on enzyme-inducing anti-convulsants including pts not on anti-epileptic drugs
Secondary objective To assess safety & tolerability of imatinib mesylate in combo w RAD001 &
hydroxyurea in this population To characterize single-dose & repeated-dose pharmacokinetic
profiles of imatinib mesylate & RAD001 combo therapy in this pt population.
To assess antiangiogenic effects, pre- and post-treatment, of imatinib mesylate, RAD001 &
hydroxyurea combo therapy, using DCE-MRI to evaluate changes in extent of vascular
permeability, perfusion & relative tumor blood volume; to explore assessment of tumor
cellularity & tumor cell death by changes in DWI-MRI as quantitated by apparent diffusion
coefficient maps.