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

Gustave Roussy, Cancer Campus, Grand Paris2 sites in 2 countries87 target enrollmentOctober 2003

ConditionsGlioma

DrugsTemozolomide, Cisplatinum

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Glioma
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Enrollment: 87
Locations: 2
Primary Endpoint: Radiological response after two courses of Temozolomide-Cisplatinum
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2003

End Date

December 2007

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Responsible Party

Sponsor

Eligibility Criteria

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