Ph I SU011248 + Irinotecan in Treatment of Pts w MG

Completed · Phase 1

Conditions studied: Glioblastoma

In brief

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

Key facts

Study ID

NCT00611728

Run by

Duke University

People needed

25

Starts

2008-03-01

Expected to finish

2010-09-01

Last updated by the study team

2014-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pts confirmed GBM, GS, AA, AO \& AOA w recurrent disease following standard therapy consisting of at least external beam XRT \& temo chemo
• Pts not had tumor biopsy <1 week/surgical resection <2 weeks prior to starting study drug
• Pts should be on non-increasing dose of steroids >7 days prior to obtaining baseline Gd-MRI of brain
• Age >18yrs
• KPS >70
• ANC >1.5 x 10 9/L
• Hgb >9 g/dL
• Platelets >100 x 10 9/L
• AST/SGOT \& ALT/SGPT <2.5 x ULN
• Serum bilirubin <1.5 x ULN
• Serum CA <12 mg/dL
• Serum creatinine <1.5 x ULN/measured 24-hr CrCl>50mL/min/1.73m\^2
• Pt has ability to understand \& provide signed informed consent that fulfills IRB guidelines

You may not qualify if…

• Prior gr3/>toxicity/failure to CPT-11 therapy
• Prior Sunitinib malate therapy
• Concurrent administration of EIAEDs
• Major surgery <2 weeks of enrollment
• History of impaired cardiac function
• Other clinically significant cardiac diseases
• Uncontrolled diabetes
• Active/uncontrolled infection requiring intravenous antibiotics
• Impairment of GI function/GI disease that may significantly alter absorption of Sunitinib malate Sutent
• Acute/chronic liver/renal disease
• Cerebrovascular accident/transient ischemic attack <6mths of study enrollment
• Pulmonary embolism <6mths of study enrollment
• Pre-existing thyroid abnormality w thyroid function that can not be maintained in normal range w medication
• Pts taking warfarin sodium
• Pts have received chemo ≤4wks to starting study drug unless they have fully recovered from all anticipated side effects of such therapy
• Pts have received immunotherapy ≤2wks to starting study drug/have not recovered from side effects of such therapy
• Pts have received investigational drugs ≤2wks to starting study drug unless they have fully recovered from all anticipated side effects of such therapy
• Pts have received XRT ≤4wks to starting study drug unless they have fully recovered from all anticipated side effects of such therapy
• Pts have undergone major non-CNS surgery ≤2wks to starting study drug/pts who have not recovered from side effects of such therapy
• Cardiac pacemaker
• Ferromagnetic metal implants other than those approved as safe for use in MR scanners
• Claustrophobia
• Obesity
• Female pts who are pregnant/breast feeding/adults of reproductive potential not employing effective method of birth control
• Known diagnosis of HIV

Where it is running

• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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