Temozolomide in children with recurrent or refractory CNS tumors.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28755

Enrollment

Registered

2005-09-06

Start date

2004-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

recurrent primitive neuro ectodermal tumors and recurrent high grade gliomas of the CNS in children.

Interventions

Two different dose schedules of temozolomide are compared: - In the standard arm 200 mg/m2/dag is administered 5 days per 28 days. - In the experimental arm 150 mg/m2 is administered 2 x 7 dagen (

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 3-18; 2. Pathology: PNET/high grade glioma measurable tumor; 3. Lansky score > 50 %; 4. Expected life span of 12 weeks or more; 5. Informed consent.

Exclusion criteria

Exclusion criteria: Non conformation to inclusion criteria.

Design outcomes

Primary

Measure	Time frame
Difference in MRI respons after 12 weeks between the 2 arms.	—

Secondary

Measure	Time frame
Difference in side effects after 12 weeks between the 2 arms.	—

Contacts

Public ContactR.E. Reddingius

Erasmus Medical Center, Sophia Children's Hospital, Dr. Molewaterplein 60

r.reddingius@erasmusmc.nl+31 (0)10 4636363

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)