Ph II Bev + Either Temozolomide/Etoposide for GBM Pts Who Have Failed Bev + Irinotecan

Completed · Phase 2

Conditions studied: Glioblastoma, Gliosarcoma

In brief

Primary objective To estimate 6-month progression free survival probability of pts w recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on bev + irinotecan Secondary Objectives To evaluate safety \& tolerability of bev + either daily temozolomide/etoposide among pts w recurrent GBM who have progressed on bev + irinotecan To evaluate radiographic response, progression free survival \& overall survival of pts w recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on bev + irinotecan

Key facts

Study ID

NCT00613028

Run by

Duke University

People needed

23

Starts

2008-04-01

Expected to finish

2011-01-01

Last updated by the study team

2013-07-16

Who can join

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

You may qualify if…

• Pts have confirmed diagnosis of GBM \& radiographic evidence of recurrence following prior therapy w bev + irinotecan
• Age >18 yrs
• Interval of >4 wks between prior surgical resection/1 week from stereotactic biopsy
• Interval of >12 wks from end of prior external beam radiation therapy (XRT) unless there is new area of enhancement consistent w recurrent tumor outside of XRT field,/there are progressive changes on MRI on >2 consecutive MRI scans >4wks apart, /there is biopsy-proven tumor progression
• Interval of >4 wks from prior chemo / investigational agent unless pt has recovered from all anticipated toxicities associated w that therapy.
• Eastern Cooperative Oncology Group (ECOG) 0-1
• Hematocrit >29percent, absolute neutrophil count (ANC)>1,000 cells/ml l, platelets > 100,000 cells/ml l
• Serum creatinine<1.5 mg/dl, serum glutamate oxaloacetate transaminase (SGOT) \& bilirubin<1.5 times upper limit of normal (ULN)
• Signed informed consent approved by Institutional Review Board (IRB) prior to pt entry
• No evidence of hemorrhage on baseline MRI/CT scan other than those that are stable gr1
• If sexually active, pts will take contraceptive measures for duration of treatments

You may not qualify if…

• Co-medication that may interfere w study results
• Active infection requiring intravenous antibiotics
• Progression to daily etoposide/progression to daily temo
• Gr3/greater toxicity related to prior bev therapy,/prior temozolomide/etoposide
• Requires therapeutic anti-coagulation with warfarin.
• Inability to comply w study and/or follow-up procedures
• Current, recent,/planned participation in experimental drug study other than Genentech-sponsored bev cancer study
• Inadequately controlled hypertension
• Any prior history of hypertensive crisis/hypertensive encephalopathy
• New York Heart Association (NYHA) Gr II/greater congestive heart failure
• History of myocardial infarction (MI)/unstable angina within 6 mths prior to study enrollment
• History of stroke/transient ischemic attack within 6 mths prior to study enrollment
• Significant vascular disease
• Symptomatic peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
• Serious, non-healing wound, ulcer, or bone fracture
• Proteinuria at screening as demonstrated by either:
• urine protein:creatinine (UPC) ratio >1.0 at screening /
• Urine dipstick for proteinuria ≥ 2+
• Known hypersensitivity to any component of bevacizumab
• Pregnant or lactating. Use of effective means of contraception in subjects of child-bearing potential

Where it is running

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

Full record on ClinicalTrials.gov

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