Ph II Bevacizumab + Etoposide for Pts w Recurrent MG

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab; Etoposide; Etoposide phosphate

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