First diagnosed glioblastoma MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Doxorubicina
Product Code: [Dox]
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: 00107001
CAS Number: 23214-92-8
Current Sponsor code: Doxorubic
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with glioblastoma, first diagnosed not previously treated (with chemotherapy and radiotherapy) or treated only surgically 2. Males and females between the ages of 3 and 30 3. Life expectancy > or = 12 months 4. Karnofsky / Lansky > or = 80% 5. Adequate haematological function: ¿ Absolute white blood cell count >= 2.0 x 10^9 / l ¿ Hemoglobin >= 10 g / dl ¿ Platelet count >= 50 x 109 / l 6. Adequate liver function: ¿ Total bilirubin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Evidence of any other serious illness or condition that is a contraindication to study therapy (e.g. severe mental retardation, severe cerebral palsy, severe congenital syndromes, heart disease) 2. Perform a 1st line chemotherapy cycle at the same time as the start of the study 3. Simultaneous participation in other research projects 4. State of pregnancy or breastfeeding 5. Use of inadequate contraceptive methods
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are: 1. Event-free survival (EFS) that is the time between the date of enrollment and the date of occurrence of one of the following events: - disease progression established according to RECIST 1.1 criteria - disease relapse - all-cause mortality 2. Overall survival (OS) defined as the time between the date of enrollment and the date of death from any cause 3. Progression-free survival (PFS) defined as the time between the date of enrollment and the date of progression according to RECIST 1.1 criteria 4. Proportion of treatment responder (CR, complete responder; PR, partial responder; SD, stable disease; PD, disease progression) according to RECIST 1.1. criteria In case of loss at follow-up, survival at the last available evaluation will be considered.;Timepoint(s) of evaluation of this end point: Every three months | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of prolonged administration of doxorubicin in combination with radiotherapy and temozolomide in pediatric and young adult patients with gliobastoma;Secondary Objective: Evaluate the effectiveness of treatment by determining event-free survival (EFS), disease progression (PFS), and overall survival (OS);Primary end point(s): The primary safety endpoint is defined as: - Time to early discontinuation of the experimental treatment with Doxorubicin - Percentage of subjects with Serious Adverse Events (SAE) that lead to withdrawal from the study - Percentage of SAE - Mortality due to adverse events - Proportion of early discontinuation of the experimental treatment with Doxorubicin;Timepoint(s) of evaluation of this end point: Every 6 months | — |
Countries
Italy
Contacts
Public ContactClinical Trial Office
Azienda Ospedaliero Universitaria Meyer
Outcome results
None listed