Ph II Bevacizumab + Etoposide for Pts w Recurrent MG

Duke University

Status and phase: Completed; Phase 2

Conditions: Glioblastoma; Gliosarcoma

Treatments: Drug: Bevacizumab and Etoposide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00612430

Pro00000379

Details and patient eligibility

About

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.

Full description

Exploratory, single-arm, ph II study designed to assess anti-tumor activity of combinatorial regimen consisting of Etoposide + Bevacizumab among patients with RMG. Primary endpoint of study is probability of progression-free survival at 6 months. Important secondary objective is to further assess safety of Etoposide & Bevacizumab for patients with recurrent malignant glioma.

If study demonstrates that combinatorial regimen of Etoposide + Bevacizumab is associated with encouraging anti-tumor activity among patients with RMG, further assessment of regimen in additional phase II & possibly phase III studies, will be considered.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Bevacizumab + Etoposide

Experimental group

Description:

Grade III and IV patients will receive: Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1st bevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day.

Treatment:

Drug: Bevacizumab and Etoposide