Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of Brainstem Tumor in Children

Phase 2 Study of Nimotuzumab in Combination With Radio-chemotherapy for the Treatment of Brainstem Tumor in Children

The purpose of this study is to evaluate the safety and efficacy of nimotuzumab in combination of radio-chemotherapy for the treatment of brainstem tumor in children.

Nimotuzumab (h-R3), a recombinant humanized monoclonal immunoglobulin G1 antibody that binds to the extracellular domain of EGFR, which blocks the binding of EGF and transforming growth factor-α to EGFR. High expression of EGFR protein in glioma has been associated with tumor progression and enhanced tumorigenicity. Several clinical trials have demonstrated the anti-tumor effects of nimotuzumab, such as head and neck cancer and esophageal cancer15. The purpose of this study was to evaluate the efficacy of nimotuzumab in combination of radio-chemotherapy for the treatment of brainstem tumors in children.

Inclusion Criteria:

• Patients must be >/= 3 and </= 21 years of age.
• Patients must have a newly diagnosed or progressive brain stem tumor.
• If biopsy has been performed, patients with both high and low grade astrocytomas are eligible.
• Non-histologically confirmed brain stem tumors are eligible. Neuroradiographic confirmation of brain stem glioma is mandatory for study entry.
• Cervicomedullary junction tumors are ineligible.
• Patients with a diagnosis of NF-1 are ineligible.
• Patients must be registered within 6 weeks from diagnosis or recurrence.
• Patients must have life expectancy > 6 weeks.
• Patients must have adequate hematologic and renal function: ANC >1,000/ul, platelets>100,000/ul and creatinine normal for age: </= 0.7 mg/dl (age 3-10yrs.), </= 1.0 mg/dl (11-12yrs.). and </= 1.2 (13-21yrs.).
• Written informed consent must be obtained according to institutional guidelines.

Exclusion Criteria:

• Cervicomedullary junction tumors are ineligible.
• Patients with a diagnosis of NF-1 are ineligible.
• Pregnant or nursing women are ineligible.
• Patients must not start treatment until informed consent is given and the patient is registered.