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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01836536
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Center Eugene Marquis
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Veronique QUILLIEN, MD
Principal Investigator Affiliation	Center Eugene Marquis
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Completed
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, Glioma

Additional Details

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.

Arms & Interventions

Arms

Other: BEVACIZUMAB

BEVACIZUMAB standard of care

Interventions

Drug: - Bevacizumab standard of care

Standard treatment associated with circulating leucocytes (blood samplings)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hôpital Avicenne, Bobigny, France

Status

Address

Hôpital Avicenne

Bobigny, , 93009

Center Eugene Marquis, Rennes, France