Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

June 30, 2014

Study Completion Date

July 31, 2014

Conditions
Diffuse Intrinsic Brainstem Gliomas
Interventions
RADIATION

Radiotherapy

Radiotherapy will be given at the standard dose between 54 and 60 Gy for irradiation of tumors of the central nervous system.

BIOLOGICAL

Nimotuzumab

The patients will receive the induction therapy for 12 weeks. If the patient reaches a complete, partial response (CR, PR) to the treatment or is at least evaluated as stable disease (SD) on week 12, the consolidation therapy should be initiated. The consolidation therapy will consist of the nimotuzumab administration, every 2 weeks.

Trial Locations (5)

Unknown

Hospital de Clínicas de Porto Alegre, Porto Alegre

Hospital Amaral Carvalho, Jaú

Casa de Saúde Santa Marcelina, São Paulo

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo

Hospital Juan Manuel Márquez, Havana

Sponsors
All Listed Sponsors
collaborator

Centro de Immunologia Molecular, Cuba

INDUSTRY

lead

Eurofarma Laboratorios S.A.

INDUSTRY