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NCT Number: NCT01836536

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

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.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Avicenne, Bobigny, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bevacizumab standard of care

Drug

Standard treatment associated with circulating leucocytes (blood samplings)

Other names: Avastin

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Registry information

Official study 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

Acronym: AVA-CELL

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 22, 2013
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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