NCT03144167 Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy
| NCT ID | NCT03144167 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2019-06-18 |
| Primary Completion | 2027-01-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2019-06-18 with a primary completion date of 2027-01-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03144167 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03144167 currently recruiting?
Yes, NCT03144167 is actively recruiting participants. Contact the research team at constans.jean-marc@chu-amiens.fr for enrollment information.
Where is the NCT03144167 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT03144167 clinical trial?
NCT03144167 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 170 participants.
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