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


Phase 2
4 Years
21 Years
Not Enrolling
Both
Glioma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Radiological response after two courses of Temozolomide-Cisplatinum

Principal Investigator

Jacques Grill, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CISTEM2

NCT ID:

NCT00147160

Start Date:

October 2003

Completion Date:

December 2007

Related Keywords:

  • Glioma
  • Glioma

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