Phase II Study of Nimotuzumab (TheraCIM®) in Pediatric Patients with Recurrent Diffuse Intrinsic Pontine Glioma
[Protocol 08-034]
Full Title :
PHASE 2 STUDY OF SAFETY AND EFFICACY OF NIMOTUZUMAB (THERACIM) IN PEDIATRIC PATIENTS WITH RECURRENT DIFFUSE INTRINSIC PONTINE GLIOMA
Purpose :
This study is evaluating the safety and effectiveness of an investigational drug called nimotuzumab in children with a brain tumor called diffuse intrinsic pontine glioma which has not responded to standard treatment with radiation therapy and chemotherapy. Nimotuzumab is a monoclonal antibody that targets the epidermal growth factor
receptor (EGFR), a protein on the surface of cancer cells which helps them to grow and divide. Nimotuzumab has been evaluated in prior clinical trials in adults and children with brain tumors, and early results have shown promising results.
Another goal of this study is to find out how much nimotuzumab is taken up into and broken down by the body.
Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
Patients must have a confirmed diagnosis of diffuse intrinsic pontine glioma which has progressed or returned despite treatment with standard therapy (including radiation therapy and chemotherapy).
Patients may not have received prior therapy that targets EGFR.
At least 2 weeks must have passed since completion of prior chemotherapy and 12 weeks since prior radiation therapy and entry into the study.
