No registrations found.
ID
Source
Brief title
Health condition
recurrent primitive neuro ectodermal tumors and recurrent high grade gliomas of the CNS in children.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in MRI respons after 12 weeks between the 2 arms.
Secondary outcome
Difference in side effects after 12 weeks between the 2 arms.
Background summary
For childen with recurrent or refractory primitive neuro ectodermal tumor (PNET) or high grade glioma of the brain, for whom there is no curative treatment, it is important to preserve quality of life as long as possible without causing significant side effects.
Temozolomide seems to be an interesting drug because it can be administered orally and has little side effects.
Not much information however is available about the administration of this drug in children.
In this protocol 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 experimentel arm 150 mg/m2 is administered 2 x 7 dagen (day 0-6 and day 14-20) per 28 days.
Effectivity and side effects are studied. The effectivity is studied by looking at radiological respons after 3 cycles.
Study objective
Administration of a higher cumulative dose of temozolomide leads to a higher respons rate in patients with recurrent primitive neuro ectodermal tumors and recurrent high grade gliomas of the CNS, while this treatment does not lead to more side effects.
Intervention
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 (day 0-6 and day 14-20) per 28 days.
Dr. Molewaterplein 60
R.E. Reddingius
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636363
r.reddingius@erasmusmc.nl
Dr. Molewaterplein 60
R.E. Reddingius
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636363
r.reddingius@erasmusmc.nl
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
Non conformation to inclusion criteria.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL190 |
| NTR-old | NTR227 |
| Other | : N/A |
| ISRCTN | ISRCTN16192422 |