Ph I SU011248 + Irinotecan in Treatment of Pts w MG

Part of paid clinical trials in Durham, North Carolina.

Sponsor: Duke University
Study ID: NCT00611728
Phase: PHASE1
Status: Completed

Conditions

Glioblastoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

SU011248 & Irinotecan — DRUG
Sutent given in daily oral manner for 1st 4 wks of each 6wk cycle. You will not take any Sutent during last 14 days of each 6 wk cycle. CPT-11 will be given intravenously over 1 \& 1/2 hrs on 1st day of each cycle \& then again on days 14 \& 28. Sutent is approved for adult subjects w some forms of kidney cancer. It is considered "investigational" for brain tumors. Dosing will begin on day 1 of cycle 1 \& continue daily for 4 wks by mouth. Irinotecan is approved for adult subjects with some forms of colorectal cancer. It is also considered "investigational" for brain tumors. Irinotecan dose will depend on your height \& weight. Irinotecan will be given intravenously over 90 min on days 1, 14 \& 28 of 6wk cycle. You will be seen in clinic approximately every 42 days for 1st 3 cycles of study drug, \& then every other cycle thereafter. Your brain MRI examination will be done within 1 wk prior to completion of cycles 1-3, \& then within 1 week prior to completion of every other cycle.

Study Details

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