The study consists in only one treatment group, which will receive the first-line therapy for the disease - standard radiotherapy and a 150 mg/m2 dose of the investigational product (nimotuzumab)
General Purpose 1\. To determine the therapeutic efficacy of the treatment with nimotuzumab in combination with radiotherapy in pediatric patients with diffuse intrinsic astrocytic of the brainstem glioma Specific Purposes 1. To determine the efficacy regarding the event-free survival (EFS) rate by 6 months of treatment. 2. To determine the overall survival time of the patients with diffuse intrinsic astrocytic tumors of the cerebral trunk treated with combined radiotherapy and nimotuzumab. 3. To determine the antitumoral objective response of the patients treated with combined radiotherapy and nimotuzumab. 4. To determine the duration time of the response in the cases of objective response reached (CR or PR) or disease stabilization. 5. To assess the toxicity of the combination AcM h-R3-nimotuzumab and radiotherapy in the patients enrolled in the clinical study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Radiotherapy will be given at the standard dose between 54 and 60 Gy for irradiation of tumors of the central nervous system.
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.
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
Casa de Saúde Santa Marcelina
São Paulo, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Tumor Volume
A Magnetic Resonance Imaging (MRI) will be used for measuring the tumor volume and it will be performed before the enrollment in the clinical study and every 12 weeks. The patient follow-up will be performed for 2 years after his/her inclusion in the investigation. The final evaluation will be performed 2 years after the inclusion of the last patient. The main response variable will be the progression-free survival by 6 months.
Time frame: 6 months
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Hospital Juan Manuel Márquez
Havana, Cuba