Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

No predictive factors are known for the response to the bevacizumab anti-angiogenic molecule (Avastin) given in the event of relapse of glioblastoma (GBM) following radiochemotherapy. Classical MRI with gadolinium injection and perfusion is not sufficient to predict survival and response or duration. We propose to evaluate the prognostic interest for 6-month survival of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism recorded at 7 and 28 days of application of the treatment. These biomarkers are based on the increase of an index combining choline / Creatine (Cho / Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine) and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed GBM patients at an early stage and to identify responder patients who would benefit from this expensive molecule and avoid using it in non-responding patients

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients, between 18 and 88 years, with glioblastoma (histologically proven) in first relapse after conventional treatment by surgery and temozolomide and radiotherapy

• Biological Criteria

‣ Polymorphonuclear neutrophils\> 1500 / mm3

⁃ Plates\> 100,000 / mm3

⁃ SGOT-SGPT \<5 at the upper limit of normal (ULN)

⁃ Bilirubin \<1.5 x ULN

⁃ Creatinine \<1.5 LSN and creatinine clearance

⁃ Proteinuria \<1 g / 24 hours

⁃ Patient with health insurance

⁃ Consent signed by the patient if he is lucid, or failing that by the person of trust

Locations
Other Locations
France
CHU Amiens Picardie
RECRUITING
Amiens
Contact Information
Primary
Jean-Marc CONSTANS, PhD
constans.jean-marc@chu-amiens.fr
+33322087511
Time Frame
Start Date: 2019-06-18
Estimated Completion Date: 2027-01-20
Participants
Target number of participants: 170
Treatments
Other: Patients, aged 18-88, with glioblastoma
Sponsors
Leads: Centre Hospitalier Universitaire, Amiens

This content was sourced from clinicaltrials.gov