Temozolomide in children with recurrent or refractory central nervous system (CNS) tumours [Temozolomide bij kinderen met een gerecidiveerde of refractaire centraal zenuwstelsel tumor]

ISRCTN ISRCTN16192422
DOI https://doi.org/10.1186/ISRCTN16192422
Secondary identifying numbers NTR227
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
24/06/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr R.E. Reddingius
Scientific

Erasmus Medical Center
Sophia Children's Hospital
Rotterdam
3015 GJ
Netherlands

Phone +31 (0)10 463 6363
Email r.reddingius@erasmusmc.nl

Study information

Study designRandomised, multicentre, active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymTMZ studie
Study objectivesAdministration of a higher cumulative dose of temozolomide leads to a higher response rate in patients with recurrent primitive neuro-ectodermal tumours and recurrent high grade gliomas of the central nervous system (CNS), while this treatment does not lead to more side effects.

Please note that as of 24/06/2008 more details on the sources of funding have been added to this record (i.e., funding now confirmed). This can be seen below in the sources of funding section.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedGlioma high grade, primitive neuroectodermal tumour (PNET)
InterventionTwo different dose schedules of temozolomide are compared:
1. In the standard arm 200 mg/m^2/dag is administered 5 days per 28 days
2. In the experimental arm 150 mg/m^2 is administered 2 x 7 dagen (day 0 - 6 and day 14 - 20) per 28 days
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Temozolomide
Primary outcome measureDifference in magnetic resonance imaging (MRI) response after 12 weeks between the two arms.
Secondary outcome measuresDifference in side effects after 12 weeks between the two arms.
Overall study start date01/01/2004
Completion date01/01/2009

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Years
Upper age limit18 Years
SexBoth
Target number of participants54
Key inclusion criteria1. Aged 3 - 18 years
2. Pathology: primitive neuroectodermal tumour (PNET)/high grade glioma
3. Measurable tumour
4. Lansky score greater than 50%
5. Expected life span of 12 weeks or more
6. Informed consent
Key exclusion criteriaNon-conformation to inclusion criteria
Date of first enrolment01/01/2004
Date of final enrolment01/01/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands

Sponsor information

Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION]) (The Netherlands)
Research organisation

Leyweg 299
Den Haag
2545 CJ
Netherlands

Phone +31 (0)70 367 4545
Email info@skion.nl
Website http://www.skion.nl/
ROR logo "ROR" https://ror.org/01zs6bp63

Funders

Funder type

Industry

Added as of 24/06/2008:

No information available

Schering-Plough B.V. (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan