Clinical trial NCT01836536: Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma
Glioma
Keywords: High grade glioma
Bevacizumab
Chemotherapy
Myeloid Cells
Treg
Lead sponsor: Center Eugene Marquis
Sponsor class: OTHER
First posted: 2013-04-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility 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.

Primary outcomes:
measure: blood cells populations
timeFrame: up to 4 months
Secondary outcomes:
measure: Cells variation and RMI response
timeFrame: 6 weeks
measure: Survival
timeFrame: Patients will be followed up from the date of randomization up to their death, assessed up to 100 months
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Rennes
country: France
facility: Center Eugene Marquis
Study officials:
affiliation: Center Eugene Marquis
name: Veronique QUILLIEN, MD
role: PRINCIPAL_INVESTIGATOR
References: