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Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients (AVA-CELL)

Primary Purpose

Glioblastoma, Glioma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bevacizumab standard of care
Sponsored by
Center Eugene Marquis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glioblastoma focused on measuring High grade glioma, Bevacizumab, Chemotherapy, Myeloid Cells, Treg

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Avicenne
  • Center Eugene Marquis

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

BEVACIZUMAB

Arm Description

BEVACIZUMAB standard of care

Outcomes

Primary Outcome Measures

blood cells populations
Analysis of blood cells populations variation during treatment with bevacizumab. Last sampling planned before the 7th cycle of bevacizumab.

Secondary Outcome Measures

Cells variation and RMI response
Relationship between variation of blood cells and RMI response after 6 weeks of treatment
Survival
Link between variation of analyzed cellular population and survival.

Full Information

First Posted
September 12, 2012
Last Updated
February 28, 2017
Sponsor
Center Eugene Marquis
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1. Study Identification

Unique Protocol Identification Number
NCT01836536
Brief Title
Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Eugene Marquis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Glioma
Keywords
High grade glioma, Bevacizumab, Chemotherapy, Myeloid Cells, Treg

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BEVACIZUMAB
Arm Type
Other
Arm Description
BEVACIZUMAB standard of care
Intervention Type
Drug
Intervention Name(s)
Bevacizumab standard of care
Other Intervention Name(s)
Avastin
Intervention Description
Standard treatment associated with circulating leucocytes (blood samplings)
Primary Outcome Measure Information:
Title
blood cells populations
Description
Analysis of blood cells populations variation during treatment with bevacizumab. Last sampling planned before the 7th cycle of bevacizumab.
Time Frame
up to 4 months
Secondary Outcome Measure Information:
Title
Cells variation and RMI response
Description
Relationship between variation of blood cells and RMI response after 6 weeks of treatment
Time Frame
6 weeks
Title
Survival
Description
Link between variation of analyzed cellular population and survival.
Time Frame
Patients will be followed up from the date of randomization up to their death, assessed up to 100 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronique QUILLIEN, MD
Organizational Affiliation
Center Eugene Marquis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Center Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France

12. IPD Sharing Statement

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

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