GlioblastomaAVA-CELLNCT01836536
Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients
A study of Glioblastoma and Glioma, run by Center Eugene Marquis at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Glioma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Known Hepatitis B or C or HIV.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Avicenne
Bobigny, 93009
Center Eugene Marquis
Rennes, 35042
About this study
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
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.
Read the 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.
- Conditions
- Glioblastoma, Glioma
- Being tested
- Bevacizumab standard of care
- Keywords
- High grade glioma, Bevacizumab, Chemotherapy, Myeloid Cells, Treg
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab standard of careDrug
Also called Avastin
Standard treatment associated with circulating leucocytes (blood samplings)
| Study group | Role | What they receive |
|---|---|---|
| BEVACIZUMAB | Other | BEVACIZUMAB standard of care Receives: Drug: Bevacizumab standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood cells populations
Analysis of blood cells populations variation during treatment with bevacizumab. Last sampling planned before the 7th cycle of bevacizumab.
Measured: up to 4 months
Secondary outcomes (2)
Cells variation and RMI response
Relationship between variation of blood cells and RMI response after 6 weeks of treatment
Measured: 6 weeks
Survival
Link between variation of analyzed cellular population and survival.
Measured: Patients will be followed up from the date of randomization up to their death, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionMar 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronique QUILLIEN, MD, Principal investigator, Center Eugene Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836536
- Sponsor's protocol ID
- AVA-CELL
- Acronym
- AVA-CELL
- Status last verified
- Feb 2017
- First submitted
- 12 Sep 2012
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01836536
- Acronym / sponsor ID
- AVA-CELL / AVA-CELL
- Conditions
- Glioblastoma, Glioma
- Keywords
- High grade glioma, Bevacizumab, Chemotherapy, Myeloid Cells, Treg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BEVACIZUMAB | Other | Drug: Bevacizumab standard of careBEVACIZUMAB standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (1 listed)
- Known Hepatitis B or C or HIV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab standard of careAlso: AvastinStandard treatment associated with circulating leucocytes (blood samplings) | Drug | BEVACIZUMAB |
Primary outcome
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.
2 secondary outcomes
Cells variation and RMI response
Time frame: 6 weeks
Survival
Time frame: Patients will be followed up from the date of randomization up to their death, assessed up to 100 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique QUILLIEN, MD principal investigator
Center Eugene Marquis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Glioblastoma and Glioma, run by Center Eugene Marquis at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood cells populations (time frame: up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.