Diffuse Intrinsic Brainstem Gliomas Clinical Trial
Official title:
Use of Nimotuzumab and Radiotherapy in the Treatment of Pediatric Patients With Diffuse Intrinsic Brainstem Glioma
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment