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 sideā¦
ID
Bron
Verkorte titel
Aandoening
recurrent primitive neuro ectodermal tumors and recurrent high grade gliomas of the CNS in children.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Difference in MRI respons after 12 weeks between the 2 arms.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
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.
Publiek
Dr. Molewaterplein 60
R.E. Reddingius
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636363
r.reddingius@erasmusmc.nl
Wetenschappelijk
Dr. Molewaterplein 60
R.E. Reddingius
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636363
r.reddingius@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Non conformation to inclusion criteria.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL190 |
NTR-old | NTR227 |
Ander register | : N/A |
ISRCTN | ISRCTN16192422 |