Status:
COMPLETED
Ph II Bev + Either Temozolomide/Etoposide for GBM Pts Who Have Failed Bev + Irinotecan
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 pts w recurrent GBM treated w bev + either daily temozolomide/etoposide following progression on bev + irinotecan Seconda...
Detailed Description
This is exploratory, two-arm, phase II study designed to assess anti-tumor activity of bev + either daily temozolomide/etoposide among GBM pts w progressive disease following bev + irinotecan. About 4...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00613028
Start Date
April 1 2008
End Date
January 1 2011
Last Update
July 16 2013
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710