Phase II study of Glivec (imatinib mesylate) in patients with advanced neuroblastoma - ND
- Conditions
- High risk NeuroblastomaMedDRA version: 6.1Level: PTClassification code 10029260
- Registration Number
- EUCTR2005-005778-63-IT
- Lead Sponsor
- ISTITUTO GIANNINA GASLINI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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< CR-VGPR at the completion of first or second line treatment or patients with metastatic relapse-progression of the disease after first-line treatment
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-Patients with severe organ dysfunction -known HIV infection -active HBV-HCV infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method