Radiosurgery and Avastin for Recurrent Malignant Gliomas

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the central nervous system (CNS) toxicity in patients with recurrent malignant gliomas treated with concurrent Avastin and stereotactic radiosurgery (SRS).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• History of malignant glioma (WHO Grade III or IV) of the brain treated with some combination of surgery, biochemotherapy and conventionally fractionated external beam radiotherapy

• Radiotherapy completed at least 6 months prior to recurrence

• Age 18 years and older

• New or enlarging contrast-enhancing and/or 18FDG-avid nodule, at least 1 cm diameter

• Estimated life expectancy of 3 months or longer

Exclusion Criteria:

• Avastin therapy within 21 days of start of participation

• Contraindication to Avastin therapy or brain MRI

• Presence of bleeding diathesis or coagulopathy

• History of prior arterial thrombotic event, myocardial infarction, angina, CVA, TIA, CABG angioplasty or stenting within 6 months.

• Inadequately controlled hypertension (defined as systolic blood pressure

• New York Heart Association (NYHA) Grade II or greater congestive heart failure

• Clinically significant vascular disease

• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to onset of treatment

• Prior history of hypertensive crisis or hypertensive encephalopathy

• History of abdominal fistula or GI perforation within 6 months prior to onset of treatment

• Serious non-healing wound, active ulcer or untreated bone fracture

• Proteinuria demonstrated by Urine Protein Creatinine ratio > 1.0

• Pregnancy