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

NCT01836536 | Completed

• 1 other identifier: AVA-CELL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Glioblastoma; Glioma

Keywords

High grade glioma; Bevacizumab; Chemotherapy; Myeloid Cells; Treg

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cells variation and RMI response

  6 weeks

• Survival

  Patients will be followed up from the date of randomization up to their death, assessed up to 100 months

Study Arms (1)

BEVACIZUMAB

OTHER

BEVACIZUMAB standard of care

Drug: Bevacizumab standard of care

Interventions

Bevacizumab standard of care DRUG

Standard treatment associated with circulating leucocytes (blood samplings)

Also known as: Avastin

BEVACIZUMAB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known Hepatitis B or C or HIV.
• 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.

Sponsors & Collaborators

• Center Eugene Marquis: lead

Study Sites (2)

Hôpital Avicenne

Bobigny, 93009, France

Location

Center Eugene Marquis

Rennes, 35042, France

Location

MeSH Terms

Conditions

Glioblastoma; Glioma

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Veronique QUILLIEN, MD

  Center Eugene Marquis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: April 22, 2013
• Study Start: September 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

FR (2)