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

Glioblastoma Clinical Trial

— AVA-CELL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836536
• Other study ID #: AVA-CELL
• Status: Completed
• Phase: N/A
• First received: September 12, 2012
• Last updated: February 28, 2017
• Start date: September 2012
• Est. completion date: August 2015

Study information

• Verified date: February 2017
• Source: Center Eugene Marquis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioma

Intervention

Drug:
• Bevacizumab standard of care
Standard treatment associated with circulating leucocytes (blood samplings)

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny
France	Center Eugene Marquis	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cells variation and RMI response	Relationship between variation of blood cells and RMI response after 6 weeks of treatment	6 weeks
Secondary	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