Ph I SU011248 + Irinotecan in Treatment of Pts w MG

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

June 30, 2010

Study Completion Date

September 30, 2010

Conditions
Glioblastoma
Interventions
DRUG

SU011248 & Irinotecan

"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."

Trial Locations (1)

27710

Duke University Health System, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Duke University

OTHER

NCT00611728 - Ph I SU011248 + Irinotecan in Treatment of Pts w MG | Biotech Hunter | Biotech Hunter