Expired Study
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Durham, North Carolina 27710


Purpose:

Primary Objective to estimate 6-month progression free survival probability of pts w recurrent malignant glioma treated w Etoposide + bevacizumab. Secondary Objectives To evaluate safety & tolerability of Etoposide + bevacizumab among pts w recurrent malignant glioma. To evaluate radiographic response, progression free survival & overall survival of pts w recurrent malignant glioma treated w Etoposide + bevacizumab.


Study summary:

Exploratory, single-arm, ph II study designed to assess anti-tumor activity of combinatorial regimen consisting of Etoposide + bevacizumab among pts w RMG. Primary endpoint of study is probability of progression-free survival at 6 mths. Important secondary objective is to further assess safety of Etoposide & bevacizumab for pts w RMG. If study demonstrates that combinatorial regimen of Etoposide + bevacizumab is associated w encouraging anti-tumor activity among pts w RMG, further assessment of regimen in additional ph II & possibly ph III studies, will be considered.


Criteria:

Inclusion Criteria: - Pts have confirmed diagnosis of recurrent/progressive WHO gr III & IV MG - Age >18 rs - Interval of >4 wks since prior surgery - Interval of >4 wks since prior XRT/chemo, unless there is unequivocal evidence of progressive disease & pts have recovered from all anticipated toxicity of most recent therapy; - Karnofsky performance status score >60 - Hematocrit >29 percent, ANC >1,500 cells/microliter, platelets >100,000 cells/microliter - Serum creatinine <1.5 mg/dl, BUN <25 mg/dl, serum SGOT & bilirubin <1.5 x ULN - For pts on corticosteroids, they have been on astable dose for 1wk prior to entry - Signed informed consent approved by IRB prior to pt entry - If sexually active, pts must agree to take contraceptive measures for duration of treatments. Exclusion Criteria: - Prior therapy w either bevacizumab/etoposide - >3 prior recurrences - Pregnancy/breast feeding - Co-medication w immuno-suppressive agents other than corticosteroids including but not limited to cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil - Evidence of CNS hemorrhage on baseline MRI on CT scan - Pts who require therapeutic anti-coagulation - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics & psychiatric illness/social situations that would limit compliance w study requirements, or disorders associated w significant immunocompromised state - Pts w another primary malignancy that has required treatment <past year


NCT ID:

NCT00612430


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: March 16, 2018

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