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

Gustave Roussy

Status and phase: Completed; Phase 2

Conditions: Glioma

Treatments: Drug: Temozolomide, Cisplatinum

Study type: Interventional

Funder types: Other

Identifiers

NCT00147160

CISTEM2

CSET-2002/978

Details and patient eligibility

About

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

Enrollment: 87 estimated patients

Sex: All

Ages: 4 to 21 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)