Ph II Bevacizumab + Etoposide for Pts w Recurrent MG

Completed · Phase 2

Conditions studied: Glioblastoma, Gliosarcoma

In brief

Primary Objective to estimate 6-month progression free survival probability of patients with recurrent malignant glioma treated with Etoposide + Bevacizumab. Secondary Objectives To evaluate safety \& tolerability of Etoposide + Bevacizumab among patients with recurrent malignant glioma (RMG). To evaluate radiographic response, progression free survival \& overall survival of patients with recurrent malignant glioma treated with Etoposide + Bevacizumab.

Key facts

Study ID

NCT00612430

Run by

Duke University

People needed

59

Starts

2007-03-01

Expected to finish

2011-09-01

Last updated by the study team

2013-08-12

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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