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NCT00147160 Clinical Trial

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

Glioma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00147160
Other study ID # CISTEM2
Secondary ID CSET-2002/978
Status Completed
Phase Phase 2
First received September 6, 2005
Last updated April 10, 2012
Start date October 2003
Est. completion date December 2007

Study information
Verified date September 2006
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 87
Est. completion date December 2007
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 21 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Temozolomide, Cisplatinum

Locations
Country Name City State
France Institut Gustave-Roussy Villejuif
United Kingdom Bristol Royal Hospital for Children Bristol

Sponsors (1)
Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Radiological response after two courses of Temozolomide-Cisplatinum
Secondary Progression-free survival
Secondary Health status and quality of life
Secondary Toxicity
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