Expired Study
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Durham, North Carolina 27710


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00611728


Primary Contact:

Principal Investigator
David A. Reardon, MD
Duke University Health System


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 23, 2018

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