Cerebrospinal fluid (CSF) and plasma pharmocokinetics of liposomal cytarabine (DepoCyte®) after intrathecal administration in children with malignant brain tumors and leptomeningeal disseminatio
- Conditions
- 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.
- Registration Number
- EUCTR2006-004982-32-AT
- Lead Sponsor
- Medical University of Vienna, Department of Pedatrics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•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 < 1.5 mg/L
•Total serum bilirubin < 2.0 mg/dL and ALT less than 5 times upper limit of normal
•Platelet count > 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
•Treatment with liposomal cytarabine not indicated
•Evidence of obstructive hydrocephalus or compartmentalization of CSF flow
•Severe uncontrolled infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method