Clinical Trial Finder

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

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.