Use of Nimotuzumab and Radiotherapy in the Treatment of Pediatric Patients With Diffuse Intrinsic Brainstem Glioma
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
1. To determine the efficacy regarding the event-free survival (EFS) rate by 6 months of
2. To determine the overall survival time of the patients with diffuse intrinsic
astrocytic tumors of the cerebral trunk treated with combined radiotherapy and
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Casa de Saúde Santa Marcelina
Brazil: Ethics Committee