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Temozolomide in children with recurrent or refractory CNS tumors.


- candidate number1400
- NTR NumberNTR227
- ISRCTNISRCTN16192422
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR6-sep-2005
- Secondary IDsN/A 
- Public TitleTemozolomide in children with recurrent or refractory CNS tumors.
- Scientific TitleTemozolomide in children with recurrent or refractory CNS tumors.
- ACRONYMTMZ studie
- hypothesisAdministration 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.
- Healt Condition(s) or Problem(s) studiedGlioma, high grade, Primitive neuroectodermal tumor (PNET)
- Inclusion criteria1. 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 criteriaNon conformation to inclusion criteria.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2004
- planned closingdate1-jan-2009
- Target number of participants54
- InterventionsTwo 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.
- Primary outcomeDifference in MRI respons after 12 weeks between the 2 arms.
- Secondary outcomeDifference in side effects after 12 weeks between the 2 arms.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD R.E. Reddingius
- CONTACT for SCIENTIFIC QUERIESMD. PhD R.E. Reddingius
- Sponsor/Initiator Stichting KinderOncologie Nederland (SKION)
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsN/A
- Brief summaryFor 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.
- Main changes (audit trail)
- RECORD6-sep-2005 - 20-dec-2006


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