Recurrent Diffuse Pontine Gliomas Clinical Trial
Official title:
Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM®) in Pediatric Patients With Recurrent Diffuse Intrinsic Pontine Glioma
This is a phase 2, single-arm, multi-center study, with a safety review component, designed to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with recurrent diffuse intrinsic pontine glioma (DIPG) following one previous regimen for their disease. Patients must be diagnosed with radiologically verified recurrent diffuse intrinsic pontine glioma that is measurable in at least two dimensions. Patients are eligible without histologic confirmation. Treatment regimen will consist of two phases-induction and consolidation.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment