A clinical study to evaluate safety and efficacy of standard and high-dose chemotherapy associated with radiotherapy in pediatric and young adults patients with metastatic medulloblastoma and other embryonal tumours

Phase 1

Conditions: Metastatic medulloblastoma and other embryonal tumours
MedDRA version: 20.0Level: PTClassification code 10027107Term: MedulloblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-000801-19-IT

Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 18

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 <21 years;
3. Life expectancy = 4 weeks
4. Karnofsky / Lansky = 40%
5. Adequate hematological function (leucocyte = 2.0 x 10^9/l - Hemoglobin = 10 g/dl - platelet = 50 x 10^9 /l);
6. Adequate liver function (total bilirubin = 2.5 x ULN - ALT/AST = 5.0 x ULN);
7. Adequate renal function (serum creatinine = 1.5 x ULN);
8. Written informed consent obtained from the patient/parents or legal representative;
9. Availability to trial treatment and ability to be compliant with the protocol
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method