Study of intensive pediatric pharmacovigilance of nimotuzumab for the treatment of malignant glioma tumors.
Not Applicable
- Conditions
- Malignant gliomas
- Registration Number
- RPCEC00000183
- Lead Sponsor
- Centro de Inmunología Molecular (CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
1. Children and adolescents between 2 and 19 years of age of btoh gender (male and female)
2. Diagnoses by histology/pathology documented or by images if stem tumor.
3. Life expectancy of at least 4 weeks.
4. Karnofsky / Lansky = 50%.
Exclusion Criteria
1. Participation in another trial.
2. Pregnant or breastfeeding.
3. Decompensated chronic disease.
4. Acute septic processes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serious Adverse Events with causal relationship with the Nimotuzumab (Recorded serious AE with definitive, very likely or likely causality relationship with the use of the Nimotuzumab). Measurement time: up to 2 years of follow-up after 1 dose of the monoclonal.
- Secondary Outcome Measures
Name Time Method