Radiosurgery and Avastin for Recurrent Malignant Gliomas
Completed · Not applicable
Conditions studied: Malignant Glioma
In brief
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).
Key facts
- Study ID
- NCT01017250
- Run by
- Duke University
- People needed
- 15
- Starts
- 2009-12-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2014-02-28
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Duke University Medical Center, Radiation Oncology — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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