To measure concentrations of liposomal cytarabine in CSF and plasma over time after intrathecal administration of liposomal cytarabine in children of different age groups with a malignant brain tumor and leptomenigeal dissemination. Measurements of concentrations of cytarabine after intrathecal administration of liposomal cytarabine will help to ensure proper dosage of liposomal cytarabine in small children, avoiding neurotoxic events and subtherapeutic drug levels.
Conditions
Interventions
Trade Name: Depocyte
Pharmaceutical Form: Emulsion for injection
Sponsors
Medical University of Vienna, Department of Pedatrics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female or male, aged between 0 and 19 years (at time of first study dose) • Malignant brain tumor with leptomeningeal dissemination or risk of leptomeningeal dissemination, for whom no routine protocol is available (for example, AT/RT or Infantile malignant glioma) OR: Relapse of a brain tumor with leptomeningeal dissemination or risk of leptomeningeal dissemination of any histology • Treatment with intrathecal administered liposomal cytarabine for therapeutic reasons • Life expectancy of at least 8 weeks • Written informed consent of parents • Serum creatinine 40.000/mm3 within 48 hours before first 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Treatment with liposomal cytarabine not indicated • Evidence of obstructive hydrocephalus or compartmentalization of CSF flow • Severe uncontrolled infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: CSF: AUC, t1/2, Cmax, Cmin, Cav(ss);Secondary Objective: Frequency and degree of toxic reactions, adverse events, and leukencephalopathy; plasma: AUC, t1/2, Cmax, Cmin, Cav(ss);Primary end point(s): Pharmacokinetics of liposomal cytarabine in CSF of infants with brain malignancy | — |
Countries
Austria
Outcome results
None listed