Ph I SU011248 + Irinotecan in Treatment of Pts w MG

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Pfizer
• Treatments: Camptothecin; Irinotecan; Sunitinib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• History of another primary malignancy that is currently clinically significant/currently requiring active intervention

• Pts unwilling to/unable to comply w protocol

• Existing intra-tumoral hemorrhage

• Concurrent participation in another clinical trial except for supportive care/non-treatment trials

• Other severe acute/chronic medical/psychiatric condition/lab abnormality that may increase risk associated w study participation/study drug administration/ may interfere w interpretation of study results, & in judgment of investigator would make subject inappropriate for entry into this study