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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01836536
Other study ID # AVA-CELL
Secondary ID
Status Completed
Phase N/A
First received September 12, 2012
Last updated February 28, 2017
Start date September 2012
Est. completion date August 2015

Study information

Verified date February 2017
Source Center Eugene Marquis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Bevacizumab standard of care
Standard treatment associated with circulating leucocytes (blood samplings)

Locations

Country Name City State
France Hôpital Avicenne Bobigny
France Center Eugene Marquis Rennes

Sponsors (1)

Lead Sponsor Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Cells variation and RMI response Relationship between variation of blood cells and RMI response after 6 weeks of treatment 6 weeks
Secondary Survival 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
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