High risk Neuroblastoma MedDRA version: 6.1 Level: PT Classification code 10029260
Conditions
Interventions
Trade Name: GLIVEC*120CPS 100MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Imatinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
ISTITUTO GIANNINA GASLINI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age between 1 and 21 years at the time of treatment -diagnosis of neuroblastoma according to INSS criteria -Disease status: patients with advanced disease (stage 4) achieving=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Patients with severe organ dysfunction -known HIV infection -active HBV-HCV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the disease control rate with glivec in children with advanced neuroblastoma;Secondary Objective: -to assess pharmacokinetics of glivec in children -to determine the toxicity of glivec in a paediatric population -to assess intermediate markers of neoplastic response in patients trated with this regimen -to collect data on the biological activity of glivec in neuroblastoma patients in regard to bone marrow disease;Primary end point(s): To determine the disease control rate with glivec in children with advanced neuroblastoma | — |
Countries
Italy
Outcome results
None listed