Metastatic medulloblastoma and other embryonal tumours MedDRA version: 20.0 Level: PT Classification code 10027107 Term: Medulloblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: METOTRESSATO TEVA - 100 MG/ML SOLUZIONE INIETTABILE 1 FLACONE DA 50 ML
Product Name: METOTREXATO
Product Code: [METOTREXATO]
Pharmaceutical Form: Solution for injection
INN or Proposed IN
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed, newly diagnosed, no previously treated patients with metastatic MB and other embryonal tumours (supratentorial primitive neuro-ectodermal tumors (sPNET) and pinealoblastoma, anaplastic large cell or partial resecate medulloblastoma (residue volume > 1,5 cm2), according to WHO 2007 classification. Patients underwent surgery 2. Males and females aged >3 years and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any disease or condition that contraindicates the use of the study treatment (es. serious mental retardation, brain palsy, congenital syndrome, cardiomyopathy) 2. Administration of anti-cancer therapy concomitantly to the study enrolment 3. Concomitant partecipation to other clinical trial 4. Pregnancy or breastfeeding 5. Non adequate contraception 6. Hypersensibility to active principles or excipients 7. Severe bone-marrow depression 8. Concomitant use of yellow fever vaccine or other live vaccines 9. Other contraindications reported in the SmPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety of standard and high-dose chemotherapy associated with craniospinal irradiation in pediatric and young adult patients with metastatic MB or other embryonal tumours.;Secondary Objective: To evaluate the effectiveness of treatment in terms of progression-free survival, overall survival and responses to therapy. To evaluate neuropsychological and psychological aspects, endocrinological and visual sequelae.;Primary end point(s): - Percentage of subjects with neurological symptoms >=G3, evaluated according to CTCAE 4.0, not present at the beginning of postoperative chemoradiotherapy and not related to the recurrence / progression of the disease - Percentage of subjects with SAE - Percentage of subjects with SAE leading to withdrawal from the study - Mortality due to adverse events;Timepoint(s) of evaluation of this end point: 24 months from the end of the treatment (end of follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression free survival (PFS) defined as time frame between the date of the enrolment and the date tumour progression ; Overall survival (OS) defined as time frame between the date of the enrolment and the death to any cause; Difference in scoring for neuropsychological (Griffiths, Rey, BVN tests, educational learning) and psycological (PedsQL, CBCL) scales; Rate of treatment response: - CR, complete response the complete disappearance of all radiographic and/or cytological evidence of tumor; - PR, partial response >= 50% reduction in the product of the perpendicular diameters of the tumor with negative cytology - SD, stable disease = 25% increase in tumor size or the appearance of tumor in previously uninvolved areas; Incidence of endocrinological and visual sequelae;Timepoint(s) of evaluation of this end point: MRI scan assessment; MRI scan assessment; Before radiotherapy, at the end of the chemioterapy and at the end of the follow-up; After induction phase and at the end of the treatment; 24 months from the end of the treatment (end of follow-up) | — |
Countries
Italy
Contacts
Public ContactCLINICAL TRIAL OFFICE
AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER
Outcome results
None listed