Status:

COMPLETED

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

Lead Sponsor:

Gustave Roussy, Cancer Campus, Grand Paris

Conditions:

Glioma

Eligibility:

All Genders

4-21 years

Phase:

PHASE2

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

Eligibility Criteria

Inclusion

  • 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

  • Malignant brain stem tumours are excluded

Key Trial Info

Start Date :

October 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2007

Estimated Enrollment :

87 Patients enrolled

Trial Details

Trial ID

NCT00147160

Start Date

October 1 2003

End Date

December 1 2007

Last Update

April 11 2012

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Institut Gustave-Roussy

Villejuif, France, 94805

2

Bristol Royal Hospital for Children

Bristol, United Kingdom, BS2 8BJ