Phase II Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents

Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00147160

Enrollment

Registered

2005-09-07

Start date

2003-10-31

Completion date

2007-12-31

Last updated

2012-04-11

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

Conditions

Glioma

Brief summary

The purpose of this study is to determine whether the combination of Temozolomide and Cisplatinum is effective in the treatment of malignant glial tumours of children and adolescents

Interventions

DRUGTemozolomide, Cisplatinum

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 21 Years

Healthy volunteers

Inclusion criteria

* Age from 4th birthday and younger than 21st birthday * Histologically documented malignant glial tumour (WHO classification grade III and IV) : astrocytoma, oligodendroglioma, oligoastrocytoma and mixed tumours * Measurable and evaluable disease by the imaging criteria (MRI) * Patient not previously treated by either of the two drugs

Exclusion criteria

* Malignant brain stem tumours are excluded

Design outcomes

Primary

Measure	Time frame
Radiological response after two courses of Temozolomide-Cisplatinum	—

Secondary

Measure	Time frame
Progression-free survival	—
Health status and quality of life	—
Toxicity	—

Countries

France, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026