Expired Study
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Durham, North Carolina 27710


Purpose:

Primary objective- To determine efficacy of Avastin, 10 mg/kg every other week, in combination with standard 5-day temozolomide in terms of response rate. Secondary objective- To determine safety of Avastin & Temozolomide in unresectable glioblastoma patients


Study summary:

Subjects have histologically confirmed WHO gr IV primary malignant glioma that is unresectable/multifocal. This is Phase II study where up to 41 subjects will receive up to 4 cycles of Avastin & Temozolomide. Avastin administered at 10 mg/kg every 14 days beginning a minimum of 7 days after biopsy/28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in 28-day cycle. Patients will receive up to 4 cycles of Avastin & Temozolomide, then proceed with standard XRT. Study will use 2-stage "minimax" study design in which 21 subjects are accrued during 1st stage, with possibility that additional 20 patients accrued during 2nd stage. In initial Phase I & II trials, 4 potential Avastin-associated safety signals were identified: hypertension, proteinuria, thromboembolic events, & hemorrhage. Avastin-associated adverse events in Phase III trials include congestive heart failure, GI perforations, wound healing complications, & arterial thromboembolic events. Most common toxicity associated with Temozolomide has been mild myelosuppression.


Criteria:

Inclusion Criteria: Patients have histologically confirmed diagnosis of WHO gr IV primary malignant glioma. Patients will be unresectable or have multifocal disease. - Age ≥ 18years & life expectancy of >12 weeks - Evidence of measurable primary CNS neoplasm on contrast enhanced MRI. - Interval of <1 week between prior biopsy/4 weeks from surgical resection & enrollment on protocol - Karnofsky ≥60% - Hemoglobin ≥9g/dl, ANC ≥1,500 cells/microliter, platelets ≥125,000 cells/microliter - Serum creatinine ≤1.5 mg/dl, serum SGOT & bilirubin ≤1.5 x ULN - For patients on corticosteroids, they must have been on stable dose for 1 week prior to entry, if clinically possible, & dose should not be escalated over entry dose level - Signed informed consent approved by IRB prior to patient entry - No evidence of > grade 1 CNS hemorrhage on baseline MRI/CT scan - If sexually active, patients will take contraceptive measures for duration of treatments Exclusion Criteria: - Pregnancy/breast feeding - Co-medication that may interfere with study results - Active infection requiring IV antibiotics - Prior or current Treatment w XRT/chemo for brain tumor, irrespective of grade of tumor - Evidence of > grade 1 CNS hemorrhage on baseline MRI or CT scan Avastin-Specific Concerns: - Inadequately controlled hypertension - Any prior history of hypertensive crisis/hypertensive encephalopathy - New York Heart Association Grade II or > congestive heart failure - History of myocardial infarction/unstable angina < 6 months prior to study enrollment - History of stroke/transient ischemic attack < 6 months prior to study enrollment - Significant vascular disease - Symptomatic peripheral vascular disease - Evidence of bleeding diathesis/coagulopathy - Major surgical procedure, open biopsy,/significant traumatic injury within 28 days prior to study enrollment/anticipation of need for major surgical procedure during course of study - Core biopsy/other minor surgical procedure, excluding placement of vascular access device, <7 days prior to study enrollment - History of abdominal fistula, GI perforation, /intra-abdominal abscess <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 OR - Urine dipstick for proteinuria ≥2+ - Known hypersensitivity to any component of Avastin - Pregnant/lactating. Use of effective means of contraception in subjects of child-bearing potential - Current, ongoing treatment with full-dose warfarin or its equivalent


NCT ID:

NCT00612339


Primary Contact:

Principal Investigator
Katherine B Peters, MD, PhD
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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