Pharmacokinetics of temozolomide in cerebrospinal fluid in children with malignant brain tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002675-19-AT

Enrollment

Registered

2015-08-21

Start date

2015-10-06

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent malignant childhood central nervous system tumors

Interventions

Trade Name: Temodal Product Name: Temodal Pharmaceutical Form: Capsule INN or Proposed INN: temozolomide CAS Number: 85622-93-1 Current Sponsor code: temozolomide Other descriptive name: TEMOZOLOMIDE

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 temozolomide for therapeutic reasons - 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: 10 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Treatment with temozolomide 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 temozolomide in patients treated with temozolomide;Secondary Objective: Measurement of CSF-levels of temozolomide in patients treated with temozolomide;Primary end point(s): CSF-levels of temozolomide identified;Timepoint(s) of evaluation of this end point: CSF-levels of temozolomide identified	—

Secondary

Measure	Time frame
Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -	—

Countries

Austria

Contacts

Public ContactMedical University of Vienna

Medical University of Vienna, Department of Pediatrics

andreas.peyrl@meduniwien.ac.at+43140400 32320

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026