Biomarkers to predict 6‑month survival with Avastin in first‑relapse glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Conventional MRI with gadolinium and perfusion does not reliably predict response or survival after bevacizumab (Avastin) for relapsed glioblastoma. This interventional effort uses MR spectroscopy to measure metabolite ratios (Cho/Cr, Glx/Cr, NAA/Cr, and lactate/Cr) at about 7 and 28 days after starting bevacizumab. Those spectroscopy biomarkers will be correlated with six‑month survival to identify early signatures of response or progression. The long‑term goal is to guide therapy selection so responders receive benefit while non‑responders avoid ineffective treatment and its risks and costs.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Amiens Picardie
  Amiens, Picardie, France Recruiting

Study contacts

• Study coordinator: Jean-Marc CONSTANS, PhD
• Email: constans.jean-marc@chu-amiens.fr
• Phone: +33322087511

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.