Spots Global Cancer Trial Database for Ph I SU011248 + Irinotecan in Treatment of Pts w MG

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Trial Identification

Brief Title: Ph I SU011248 + Irinotecan in Treatment of Pts w MG

Official Title: A Phase I Study of SU011248 Plus Irinotecan in the Treatment of Patients With Malignant Glioma

Study ID: NCT00611728

Conditions

Glioblastoma

Interventions

SU011248 & Irinotecan

Study Description

Brief Summary: Primary Objectives To determine maxi tolerated dose \& dose limiting toxicity of SU011248 + Irinotecan in recurrent MG pts not on EIAEDs To characterize safety \& tolerability of SU011248 + Irinotecan among pts w recurrent MG Secondary Objectives To evaluate pharmacokinetic profile of SU011248 \& Irinotecan when co-administered in pts w MG To evaluate anti-tumor activity of SU011248 + Irinotecan

Detailed Description: Primary interest for combining SU011248 w irinotecan in malignant glioma pts derives from dramatic anti-tumor activity recently demonstrated among RMG pts treated w humanized anti-VEGF monoclonal antibody, bevacizumab, when combined w irinotecan. 63 percent radiographic response rate was observed following treatment w regimen every other wk, \& median progression-free survival was 23wks. Similar enhancement of chemo activity by VEGF-directed therapy w bev has been previously demonstrated for colorectal \& lung cancer pts. SU011248 is being evaluated in current regimen because it may exert more potent anti-angiogenic effect than bev among MG pts due to its ability to inhibit PDGFR-mediated pericyte stabilization in tumor neovasculature. Current proposed ph I study is designed to determine MTD \& DLT of SU011248 when combo w irinotecan for pts w RMG. Both SU01148 \& irinotecan are known to be metabolized by CYP3A4 cytochrome system. Current study will limit enrollment to pts who are not on CYP3A4-enzyme inducing anti-epileptic drugs.