Biomarkers to predict 6‑month survival with Avastin in first‑relapse glioblastoma
Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy
This project will test whether early MRI spectroscopy markers can predict which people with first‑relapse glioblastoma treated with Avastin will live six months or longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Drugs / interventions | bevacizumab |
| Locations | 1 site (Amiens, Picardie) |
| Trial ID | NCT03144167 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–88 with histologically confirmed glioblastoma in first relapse after surgery and standard radiochemotherapy who are eligible for bevacizumab and meet laboratory and consent requirements.
Not a fit: Patients previously treated with anti‑angiogenic agents or Gliadel, those with symptomatic tumor hemorrhage, severe coagulopathy, Karnofsky performance score under 50%, or standard contraindications to MRI are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, clinicians could identify early which patients are likely to benefit from Avastin and avoid exposing non‑responders to its side effects and cost.
How similar studies have performed: Small studies and perfusion‑MRI work have suggested potential imaging predictors of response to anti‑angiogenic therapy, but no robust, widely adopted MR spectroscopy biomarker for bevacizumab response has been established, so this approach remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Amiens, Picardie
- CHU Amiens Picardie — Amiens, Picardie, France (Recruiting)
Study contacts
- Study coordinator: Jean-Marc CONSTANS, PhD
- Email: constans.jean-marc@chu-amiens.fr
- Phone: +33322087511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.