Status:
COMPLETED
Ph II Bevacizumab + Etoposide for Pts w Recurrent MG
Lead Sponsor:
Duke University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 \...
Detailed 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 probabi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00612430
Start Date
March 1 2007
End Date
September 1 2011
Last Update
August 12 2013
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710