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

NCT03144167 | Recruiting

• 1 other identifier: PI2016_843_0027
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Glioblastoma; Radiotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Analyze 6-month survival defined as the time between inclusion in the protocol and death

  6 months

Study Arms (1)

Patients, aged 18-88, with glioblastoma

OTHER

Other: Analysis of spectroscopic biomarkers of proliferation for six-month survival

Interventions

Analysis of spectroscopic biomarkers of proliferation for six-month survival OTHER

Analysis of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism for six-month survival

Patients, aged 18-88, with glioblastoma

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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 and recurrence).
• 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 (with the exception of operative cutaneous tumors, in situ cancer of the cervix or breast treated).
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jean-Marc CONSTANS, PhD

CONTACT

+33322087511; constans.jean-marc@chu-amiens.fr

Study Design

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

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 8, 2017
• Study Start: June 18, 2019
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

FR (1)