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NCT Number: NCT03144167

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Jean-Marc CONSTANS, PhD

CONTACT

[email protected]

+33322087511

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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 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
  • History of haemoptysis dating less than 1 month.
  • Pulmonary embolism dating less than 1 month.
  • Surgical intervention (other than craniotomy or stereotactic biopsy) dating less than one month or essential and predictable surgery.
  • History of digestive fistula or intestinal perforation with resolution less than 6 months.
  • Hypersensitivity to bevacizumab or to any of the excipients mentioned in Composition.
  • Hypersensitivity to Chinese hamster ovary (CHO) cells or to other human or humanized recombinant antibodies.
  • Severe Myelosuppression
  • Pregnant or nursing. Contraception should be prescribed if necessary during treatment.
  • Persons deprived of liberty or placed under safeguard of justice (guardianship or curatorship),
  • Subject involved in another search including an exclusion period still in progress at pre-inclusion
  • Patient refusing to participate in the study

Treatment and study plan

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

Primary outcomes

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

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Marc CONSTANS, PhD

CONTACT

[email protected]

+33322087511

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: SPECTROBEVA

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
May 8, 2017
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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