Expired Study
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Durham, North Carolina 27710


Purpose:

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


Study summary:

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 48 participants w recurrent GBM will take part in this study. Approximately 24 participants will receive bev plus temozolomide & approximately 24 will receive bev + etoposide. Pts must have confirmed diagnosis of GBM & radiographic evidence of recurrence following prior therapy bev + irinotecan. 24 pts will be enrolled onto each arm of this single-stage study. If 4 or more of these 24 pts live 6/more months without disease progression, treatment regimen will be considered worthy of further investigation. Otherwise, treatment regimen will be determined not worthy of further investigation within pt population. Type I & II error rates associated w testing are 0.030 & 0.115 respectively. Management guidelines dose reduction/interruption for temo, etoposide, & bev.


Criteria:

Inclusion Criteria: - 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 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. - ECOG 0-1 - Hematocrit >29percent, ANC>1,000 cells/ml l, platelets > 100,000 cells/ml l - Serum creatinine<1.5 mg/dl, serum SGOT & bilirubin<1.5 times ULN - Signed informed consent approved by 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 Criteria: - 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 - NYHA Gr II/greater congestive heart failure - History of 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: - 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


NCT ID:

NCT00613028


Primary Contact:

Principal Investigator
David A. Reardon, MD
Duke University Health System


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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