Persistent Glioblastoma Multiforme, grade IV MedDRA version: 20.0 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: AGuIX
Product Code: [N/A]
Pharmaceutical Form: Powder for concentrate for solution for infusion
Current Sponsor code: n/a
Concentration unit: mg/kg milligram(s)/kilogram
Concentration ty
Sponsors
DIPARTIMENTO BIOMEDICINA E PREVENZIONE UNIVERSITà DEGLI STUDI DI ROMA TOR VERGATA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have previously a partial resection, biopsy or radiological diagnosis of Glioblastoma multiforme (GBM, WHO grade IV). 2. Not fit for Standard RT (60Gy/30 fractions over 6 weeks) in combination with Temozolomide 3. Patient’s age > 18 yo 4. Life expectancy = 3 months 5. Liver function (GGT, PAL, ASAT, ALAT, bilirubin) 100x10(9)/L (100,000 cells/mm3), Absolute granulocyte count (AGC) > 1.5 x 10(9)/L (1.500 cells/mm3), total serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Patients unable to undergo or tolerate MRI 2. Patients with contra-indication, sensitivity, or allergy to gadolinium or gadolinium-based contrast agents 3. Patients who have previously received brain irradiation 4. Patients with negative MRI within 72 hours after surgery 5. Age <18 yo 6. Standardized creatinine clearance < 50ml/min/1.73m² 7. History of nephropathy 8. Patients with, serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment or with any condition that does not permit compliance with the protocol 9. Patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide. 10. Patients with known contra-indication, sensitivity or allergy to gadolinium 11. Patients unable to undergo or tolerate Magnetic Resonance Imaging or with known contra-indication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements or certain metal implants). 12. Pregnancy or breastfeeding 13. Subject under administrative or judicial control 14. Psychological disorder or social or geographic reasons that may compromise medical monitoring of the trial or compliance with treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We will translate the C-map, T1-map based, MRI technique pioneered by the applicant and optimize it for human scanners and human clearance rates. This will allow to derive individual tumor concentration maps as well as AGuIX clearance curves (see preliminary results), hence deriving a precise and personalized spatiotemporal characterization of AGuIX pharmacodynamics and therefore maximum boost in RT efficacy.;Secondary Objective: We will evaluate the effect of AGuIX-enhanced RT (see O1) on GBM evolution in 30 patients. Moreover, patients who fail the screening will be treated with standard treatment and observed. All patients will undergo longitudinal multimodal neuroimaging to evaluate tumor metabolism and GTV. Quality of life (QOL) will be evaluated before and during two years since protocol inception through the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire. Cognitive abilities will be measured by the Mini-Mental State Exam (MMSE) and Montreal Cognitive Assessment (MoCA) test. Finally, the following parameters will be collected and recorded by the physician in order to assess common side effects arising during RT+TMZ: nausea, vomiting, anorexia, rash, increased liver enzymes, hypoalbuminemia, pneumonia, deep vein thrombosis, pulmonary thromboembolism, infections, thrombocytopenia, lymphopenia, neutropenia, anemia, death from the pathology under study.;Primary end point(s): The primary endpoint will be overall response rate (ORR), defined as the percentage of patients who have a partial or complete response to therapy according to RANO criteria;Timepoint(s) of evaluation of this end point: End of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.PFS, defined as the time interval between the date of randomization and the date of disease progression or death. Disease progression is defined as objective radiological progression or neurological, clinical progression. 2.OS, defined as the time interval between the date of randomization and the date of death from any cause. Toxicity defined as ability of a chemical substance or pharmaceutical preparation to cause, at certain doses or concentrations, disturbances, or damage to living organisms to which they have been administered. 3.QoL, as Measured by FACT-Br, cognition after treatment as Measured by the MMSE and MoCA test. All patients must complete a quality-of-life questionnaire before, during and after the follow-up. 4.Side effects, filling in a questionnaire with the following parameters: nausea, vomiting, anorexia, rash, increased liver enzymes, hypoalbuminemia, pneumonia, deep vein thrombosis, pulmonary thromboembolism, infections, thrombocytopenia, lymphopenia, neutropenia, anemia, death from the pathology under study.;Timepoint(s) of evaluation of this end point: 1.When the event occurs 2.When the event occurs 3.Ad each visit 4.Ad every visit | — |
Countries
Italy
Contacts
Public ContactClinical Operation
Link Neuroscience and Health Care srl - L.N.Age srl
Outcome results
None listed