Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma
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|ClinicalTrials.gov Identifier: NCT00501891|
Recruitment Status : Completed
First Posted : July 16, 2007
Results First Posted : April 22, 2013
Last Update Posted : May 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Drug: Bevacizumab Drug: Metronomic Temozolomide||Phase 2|
This is a phase II trial of the combination of Avastin and metronomic temozolomide in recurrent WHO grade IV malignant glioma patients. Patients will receive up to 12 cycles of Avastin and temozolomide and cycles are continuous 28 days. Patients will receive daily temozolomide at a dose of 50mg/m2 and will receive Avastin every other week at a dose of 10mg/kg. Patients will be required to have a baseline MRI within 2 weeks of starting treatment and a repeat MRI every 8 weeks. A total of 32 patients will be enrolled at Duke.
Patients with recurrent malignant gliomas have a very poor prognosis, so new therapies are needed. Given the activity of metronomic temozolomide and the safety and activity of Avastin against malignant glioma, it is reasonable to study the combination in recurrent malignant glioma patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||November 2009|
Experimental: Bevacizumab and Metronomic Temozolomide
Patients will receive up to 12 cycles of bevacizumab (Avastin) and metronomic temozolomide (Temodar), and each cycle is 28 days. Bevacizumab will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
Bevacizumab administered intravenously 10mg/kg every other week.
Other Name: Avastin
Drug: Metronomic Temozolomide
Temozolomide 50mg/m2 given orally on a daily basis.
Other Name: Temodar
- 6-Month Progression-free Survival [ Time Frame: 6 months ]Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause. [Optional: Macdonald criteria are standard criteria in neuro-oncology. Tumor assessment was made according to the adapted MacDonald criteria based on the combined evaluation of: 1) assessment of the MRI scan for measurable, evaluable, and new lesions (made by the independent external expert too), 2) overall assessment of neurological performance (made by the investigator), 3) concomitant steroid use (as reported by the investigator).]
- Response Rate [ Time Frame: 27 months ]The number of participants with complete or partial response as determined by a modification of the Macdonald criteria. Complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.
- Incidence and Severity of CNS Hemorrhage and Systemic Hemorrhage [ Time Frame: 27 months ]Number of participants experiencing a Central Nervous System (CNS) hemorrhage or systemic hemorrhage
- Incidence of Grade ≥ 4 Hematologic or Grade ≥ 3 Non-hematologic Toxicity [ Time Frame: 27 months ]Number of participants experiencing a grade ≥4 hematologic or grade ≥3 non-hematologic toxicity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501891
|United States, North Carolina|
|Duke University Medical Center (Brain Tumor Center)|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Annick Desjardins, MD||Duke Health|