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

Not Applicable

Completed

• Conditions: Glioblastoma; Glioma
• Interventions: Drug: Bevacizumab standard of care

• Registration Number: NCT01836536
• Lead Sponsor: Center Eugene Marquis

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2013-04-19
• Study First Posted: 2013-04-22
• Primary Completion: 2015-03
• Study Completion: 2015-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BEVACIZUMAB	Bevacizumab standard of care	BEVACIZUMAB standard of care

Primary Outcome Measures

Name	Time	Method
blood cells populations	up to 4 months	Analysis of blood cells populations variation during treatment with bevacizumab. Last sampling planned before the 7th cycle of bevacizumab.

Secondary Outcome Measures

Name	Time	Method
Cells variation and RMI response	6 weeks	Relationship between variation of blood cells and RMI response after 6 weeks of treatment
Survival	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.

Trial Locations

Locations (2)

Center Eugene Marquis; 🇫🇷 Rennes, France

Hôpital Avicenne; 🇫🇷 Bobigny, France