The purpose of this study is to determine whether bevacizumab and nimustine are effective in the treatment of recurrent high grade glioma and to explore whether there is any subgroup being sensitive to this therapeutic protocol.
Although anti-angiogenesis therapy for glioblastoma(GBM) are showing promise, GBMs often develop resistance to treatment within months or weeks after salvage therapy. There are still no effective markers to predict the response rate to bevacizumab. So the investigators initiate a single-arm Phase II study to evaluate the efficacy and tolerability of bevacizumab and nimustine regimen and to explore the predictive markers in patients with recurrent high-grade glioma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Bevacizumab is administered intravenously at 5mg/kg every 3 weeks.
Nimustine is administered intravenously at 90mg/m\^2 to 110mg/m\^2 every 6 weeks.
Huashan hospital, Fudan University
Shanghai, Shanghai Municipality, China
All cause response to treatment
Response will be evaluated according to the Response Assessment in Neuro-Oncology(RANO) criteria.Imaging Data (postcontrast T1W,T2/FLAIR),clinical symptoms and corticosteroid use will be collected in each participant and response assessment will be performed by one neurosurgeon and one neuroradiologist.
Time frame: 3 weeks
All cause mortality
Time frame: One year
All cause disease progression
Progression disease will be evaluated according to the RANO criteria
Time frame: 3 weeks
All cause severe toxicities
All toxicities will be assessed and graded according to CTCAE v4.03
Time frame: 3 weeks
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