EUCTR2006-004982-32-AT
Active, not recruiting
Not Applicable
Cerebrospinal fluid (CSF) and plasma pharmocokinetics of liposomal cytarabine (DepoCyte®) after intrathecal administration in children with malignant brain tumors and leptomeningeal dissemination
Medical University of Vienna, Department of Pedatrics0 sitesFebruary 2, 2007
DrugsDepocyte
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- 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.
- Sponsor
- Medical University of Vienna, Department of Pedatrics
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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)
- •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
Exclusion Criteria
- •Treatment with liposomal cytarabine not indicated
- •Evidence of obstructive hydrocephalus or compartmentalization of CSF flow
- •Severe uncontrolled infection
Outcomes
Primary Outcomes
Not specified
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