Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Glioma, Glioblastoma

Intervention / Treatment
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* Drug: Bevacizumab standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically proved recurrent glioblastoma or anaplasic glioma, Tumor recurrence documented by MRI at least 3 months after the end of radiotherapy or chemotherapy. Patients for whom a treatment by bevacizumab is proposed by a multidisciplinary team staff. Age ≥ 18. Signed informed consent. Affiliation to a social security coverage Exclusion Criteria: Known Hepatitis B or C or HIV. Inclusion in another clinical trial. Patient having received an anti-angiogenic therapy. Pregnant or breast-feeding woman. Person deprived of liberty or under guardianship or trusteeship or judicial protection Inability to give informed consent Person unable or unwilling to comply with the requirements of the protocol for geographical, social or psychological reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BEVACIZUMAB<br>BEVACIZUMAB standard of care | Drug: Bevacizumab standard of care<br>* Standard treatment associated with circulating leucocytes (blood samplings)<br>* Other names: Avastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood cells populations | Analysis of blood cells populations variation during treatment with bevacizumab. Last sampling planned before the 7th cycle of bevacizumab. | up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cells variation and RMI response | Relationship between variation of blood cells and RMI response after 6 weeks of treatment | 6 weeks | 
| Survival | Link between variation of analyzed cellular population and survival. | Patients will be followed up from the date of randomization up to their death, assessed up to 100 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High grade glioma, Bevacizumab, Chemotherapy, Myeloid Cells, Treg