Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma
Completed · Phase 2
Conditions studied: Glioblastoma Multiforme
In brief
This is a phase II study of the combination of Avastin and metronomic temozolomide in recurrent malignant glioma patients. The primary objective will be to determine the efficacy of Avastin (bevacizumab) and metronomic temozolomide in malignant glioma patients. The secondary objective will be to determine the safety of Avastin, 10 mg/kg every other week, in combination with metronomic temozolomide in terms of progression-free survival.
Key facts
- Study ID
- NCT00501891
- Run by
- Duke University
- People needed
- 32
- Starts
- 2007-07-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2013-05-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have histologically confirmed diagnosis of WHO grade IV primary malignant glioma
- Karnofsy Performance Status (KPS) >/= 60%
- Evidence of measurable primary CNS neoplasm on contrast-enhanced MRI.
- An interval of at least 4 weeks between prior surgical resection or 1 week from a biopsy and enrollment on this protocol
- An interval of at least 4 weeks from the end of prior radiotherapy or one week from the end of a cycle of chemotherapy and enrollment on this protocol.
- No evidence of CNS hemorrhage on the baseline MRI or CT scans
You may not qualify if…
- Life expectancy < 8 weeks
- Pregnancy or breast feeding
- Progression to metronomic temozolomide, defined as tumor progression while taking daily temozolomide or progression within 4 weeks of stopping metronomic temozolomide
- Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
Where it is running
- Duke University Medical Center (Brain Tumor Center) — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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