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

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ClinicalTrials.gov Identifier: NCT01836536
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Glioblastoma Glioma Drug: Bevacizumab standard of care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : September 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
BEVACIZUMAB
BEVACIZUMAB standard of care
Drug: Bevacizumab standard of care
Standard treatment associated with circulating leucocytes (blood samplings)
Other Name: Avastin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cells variation and RMI response [ Time Frame: 6 weeks ]
    Relationship between variation of blood cells and RMI response after 6 weeks of treatment

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836536


Locations
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France
Hôpital Avicenne
Bobigny, France, 93009
Center Eugene Marquis
Rennes, France, 35042
Sponsors and Collaborators
Center Eugene Marquis
Investigators
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Principal Investigator: Veronique QUILLIEN, MD Center Eugene Marquis

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Responsible Party: Center Eugene Marquis
ClinicalTrials.gov Identifier: NCT01836536    
Other Study ID Numbers: AVA-CELL
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Keywords provided by Center Eugene Marquis:
High grade glioma
Bevacizumab
Chemotherapy
Myeloid Cells
Treg
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors