Nimotuzumab and Radiotherapy in Pediatric Patients With Glioma

Inclusion Criteria

• •1. Pediatric patients with diffuse intrinsic brainstem gliomas, documented by standard imaging techniques (MRI). Note: Tumor biopsy and histological confirmation are not required in this study.
• •2. Patients eligible for radiotherapy with Cobalt60. The patients should not have received a previous specific oncological treatment.
• •3. Aged \> 3 years old \< 18 years old
• •4. Patients with measurable lesions, defined as those that can be accurately measured in at least 2 dimensions (the 2 largest perpendicular diameters), using standard techniques (MRI).
• •5. Female patients with childbearing potential should present a negative pregnancy test and adopt effective birth control methods, in case they are sexually active.
• •6. Male patients who can father a child should adopt effective birth control methods, in case they are sexually active.
• •7. Life expectancy \> 12 weeks
• •8. Health general status, according to Karnofsky Index \> 40% (Karnofsky Index for patients \> 16 years old), Lansky \> 40% (for patients \< 16 years old)
• •9. Laboratory parameters within the normal limits, defined as: Hematopoietic: Hemoglobin \> 10 g/L, Total Leukocytes \> 2 x 109 cells/L, Platelets \> 100 x 109/L; Hepatic: Liver functioning within the normal limits and without hepatic diseases demonstrated by ALT, AST \< 2.5 x above the reference value and Total Bilirubin \< 1.5 x above the reference value; Renal function: Serum Creatinine \< 1.5 x above the reference value.
• •10. The parents or legal guardians should express, voluntarily, in writing, that the patient will be enrolled in the study upon signature of the informed consent form. At the investigator's discretion, where applicable, the consent will be obtained from the minor.