Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients (AVA-CELL)
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|ClinicalTrials.gov Identifier: NCT01836536|
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : March 1, 2017
Bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), is an antiangiogenic treatment currently proposed to recurrent high grade glioma patients. Unfortunately some patients fail to respond to this treatment and finding biological factors allowing the discrimination between potential responders and non responders would be very helpful. As the immune system plays a key role in angiogenesis induction and maintenance in cancer, it could serve as a surrogate marker of angiogenesis in cancer patients.
The purpose of this study is to determine the influence of bevacizumab treatment on circulating immune cells in high grade glioma patients and to search for a link between the variation of these cells and the response to treatment.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Glioma||Drug: Bevacizumab standard of care||Not Applicable|
The following leucocyte subsets will be analyzed in whole blood before treatment and before cycles 3, 5 and 7:
- Classical, intermediate, nonclassical and Tie2 expressing monocytes.
- Regulatory T cells (Treg).
- Myeloid Derived Suppressor cells (MDSCs) The variation of the absolute numbers (or relative percentages) of the cells in the blood of patients will be correlated to the response to treatment assessed according to the RANO criteria.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Analysis of Different Circulating Immune Cells in Patients With Recurrent Glioblastoma or Mixed Anaplasic Glioma Treated With Bevacizumab and Search for a Link With Response to Treatment|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||August 2015|
BEVACIZUMAB standard of care
Drug: Bevacizumab standard of care
Standard treatment associated with circulating leucocytes (blood samplings)
Other Name: Avastin
- blood cells populations [ Time Frame: up to 4 months ]Analysis of blood cells populations variation during treatment with bevacizumab. Last sampling planned before the 7th cycle of bevacizumab.
- Cells variation and RMI response [ Time Frame: 6 weeks ]Relationship between variation of blood cells and RMI response after 6 weeks of treatment
- Survival [ Time Frame: Patients will be followed up from the date of randomization up to their death, assessed up to 100 months ]Link between variation of analyzed cellular population and survival.
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): NCT01836536
|Bobigny, France, 93009|
|Center Eugene Marquis|
|Rennes, France, 35042|
|Principal Investigator:||Veronique QUILLIEN, MD||Center Eugene Marquis|