Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma
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|ClinicalTrials.gov Identifier: NCT02698280|
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : July 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Bevacizumab Drug: Nimustine||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bevacizumab and Nimustine in Patients With Recurrent High Grade Glioma|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||May 2018|
Patients are treated with bevacizumab and nimustine. Every 6 weeks is defined as one therapeutic cycle. Adverse effect is evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE; version 4.03). Hematologic toxicity is evaluated every 2 weeks. Liver function, renal function, and electrolytes are assessed every 4-6 weeks. Platelet should be no less than 100*10^9/L and neutrophil count should be no less than 1.5*10^9/L.
Bevacizumab is administered intravenously at 5mg/kg every 3 weeks.
Other Name: Avastin
Nimustine is administered intravenously at 90mg/m^2 to 110mg/m^2 every 6 weeks.
- All cause response to treatment [ Time Frame: 3 weeks ]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.
- All cause mortality [ Time Frame: One year ]
- All cause disease progression [ Time Frame: 3 weeks ]Progression disease will be evaluated according to the RANO criteria
- All cause severe toxicities [ Time Frame: 3 weeks ]All toxicities will be assessed and graded according to CTCAE v4.03
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): NCT02698280
|Huashan hospital, Fudan University|
|Shanghai, Shanghai, China, 200040|
|Study Chair:||Yu Yao, MD, PhD||Department of Neurosurgery, Huashan hospital|
|Study Chair:||Daoying Geng, MD||Department of Radiology, Huashan hospital|
|Principal Investigator:||Xiaojie Ding, MD||Department of Neurosurgery, Huashan hospital|
|Principal Investigator:||Jianbo Wen, MD||Department of Radiology, Huashan hospital|