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Phase II Trial of Bevacizumab Plus Etoposide for Patients With Recurrent Malignant Glioma

Phase 2
18 Years
Open (Enrolling)
Glioblastoma, Gliosarcoma

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Trial Information

Phase II Trial of Bevacizumab Plus Etoposide for Patients With Recurrent Malignant Glioma

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.

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

- Karnofsky performance status score >60

- Hematocrit >29 percent, ANC >1,500 cells/microliter, platelets >100,000

- 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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6 mth progression-free survival

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

David A. Reardon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System


United States: Institutional Review Board

Study ID:




Start Date:

March 2007

Completion Date:

June 2010

Related Keywords:

  • Glioblastoma
  • Gliosarcoma
  • Glioblastoma
  • Gliosarcoma
  • GBM
  • MG
  • Brain tumor
  • Bevacizumab
  • Avastin
  • Etoposide
  • VP-16
  • Etopophos
  • Toposar
  • VePesid
  • Glioblastoma multiforme
  • Recurrent GBM
  • Anaplastic astrocytoma
  • Malignant glioma
  • Glioblastoma
  • Gliosarcoma
  • Glioma



Duke University Health System Durham, North Carolina  27705