Recurrent malignant childhood central nervous system tumors
Conditions
Sponsors
Universitätsklinik für Kinder- und Jugendheilkunde, Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female or male, aged between 0 and 19 years (at time of initial diagnosis) • Recurrent brain tumor with leptomeningeal dissemination or risk of leptomeningeal dissemination of any histology • Treatment with intravenously administered bevacizumab for therapeutic reasons for at least 98 days (after predicted steady-state is reached) • Treatment with intrathecal administered chemotherapy for therapeutic reasons • Life expectancy of at least 8 weeks • Written informed consent of patients and/or parents • Serum creatinine 40.000/mm3 within 48 hours before intrathecal treatment 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Treatment with bevacizumab not indicated • Intrathecal therapy not indicated • Evidence of obstructive hydrocephalus or compartmentalization of CSF flow • Severe uncontrolled infection • Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Measurement of CSF-levels of bevacizumab in patients treated with bevacizumab;Secondary Objective: ;Primary end point(s): CSF-levels of bevacizumab identified | — |
Countries
Austria
Outcome results
None listed