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

February 28, 2017 updated by: Center Eugene Marquis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France, 93009
        • Hôpital Avicenne
      • Rennes, France, 35042
        • Center Eugene Marquis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: BEVACIZUMAB
BEVACIZUMAB standard of care
Drug: Bevacizumab standard of care
Standard treatment associated with circulating leucocytes (blood samplings)
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood cells populations
Time Frame: up to 4 months
Analysis of blood cells populations variation during treatment with bevacizumab. Last sampling planned before the 7th cycle of bevacizumab.
up to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cells variation and RMI response
Time Frame: 6 weeks
Relationship between variation of blood cells and RMI response after 6 weeks of treatment
6 weeks
Survival
Time Frame: 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.
Patients will be followed up from the date of randomization up to their death, assessed up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center Eugene Marquis

Investigators

  • Principal Investigator: Veronique QUILLIEN, MD, Center Eugene Marquis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

April 19, 2013

First Posted (Estimate)

April 22, 2013

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVA-CELL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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