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

Phase

N/A

Condition

Astrocytoma

Cancer

Gliomas

Treatment

Analysis of spectroscopic biomarkers of proliferation for six-month survival

Clinical Study ID

NCT03144167

PI2016_843_0027

Ages > 18
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Patients, between 18 and 88 years, with glioblastoma (histologically proven) infirst relapse after conventional treatment by surgery and temozolomide andradiotherapy
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 oftrust

Exclusion

Exclusion Criteria:

Patients who can not benefit from bevacizumab for the following reasons:
Symptomatic cerebral or tumor hemorrhage
Karnofsky Index less than 50% or
Patients already treated with an antiangiogenic molecule or Gliadel (diagnosis andrecurrence).
Coagulation disorders in case of injectable treatment (especially for avastin),
Contraindications known to the MRI: Pace Makers, foreign bodies intraocular,electrodes ...
Uncontrolled severe concomitant pathology, including another evolving cancer (withthe exception of operative cutaneous tumors, in situ cancer of the cervix or breasttreated).
Uncontrolled Infection
Uncontrolled hypertension (PAS> 160 mm Hg) despite optimized treatment
Coronary artery disease or unstable arterial disease. Evolutionary aneurysm.
Myocardial infarction dating from less than 6 months.
Peripheral arterial or cerebrovascular accident occurring less than 6 months.
Heart Failure> grade II NYHA
Hemorrhagic Disease (Hemophilia, Willebrandt ...)
Nephrotic syndrome with proteinuria> 2 g / 24 h
History of haemoptysis dating less than 1 month.
Pulmonary embolism dating less than 1 month.
Surgical intervention (other than craniotomy or stereotactic biopsy) dating lessthan one month or essential and predictable surgery.
History of digestive fistula or intestinal perforation with resolution less than 6months.
Hypersensitivity to bevacizumab or to any of the excipients mentioned inComposition.
Hypersensitivity to Chinese hamster ovary (CHO) cells or to other human or humanizedrecombinant antibodies.
Severe Myelosuppression
Pregnant or nursing. Contraception should be prescribed if necessary duringtreatment.
Persons deprived of liberty or placed under safeguard of justice (guardianship orcuratorship),
Subject involved in another search including an exclusion period still in progressat pre-inclusion
Patient refusing to participate in the study

Study Design