Full TitleA Phase I Study of Convection-Enhanced Delivery of 124I-Omburtomab for Patients with Non-Progressive Diffuse Pontine Gliomas Previously Treated with External Beam Radiation Therapy
Diffuse intrinsic pontine glioma (DIPG, also known as brain stem glioma) is a cancer of the brain stem, most often in children, which is very difficult to treat successfully. Radiation treatment is usually the first form of therapy, followed by chemotherapy. While patients may respond to therapy initially, the tumor almost always returns. Unfortunately, patients invariably succumb to these tumors. Doctors are therefore seeking more effective treatments.
Researchers are conducting this study to find the highest dose of a novel therapy called 124I-8H9 which can be given safely to children with diffuse pontine glioma who have already received radiation therapy. The therapy includes radioactive iodine attached to an antibody called 8H9 which homes in on tumor cells. When 8H9 binds to a tumor cell, the radioactive iodine can kill the cell.
124I-8H9 is given to the patient through a technique called “convection-enhanced delivery,” in which the therapy is delivered through a small tube inserted into the tumor during a surgical procedure. The delivery of the agent is performed in the operating room only, and the catheter is removed afterward.
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 not progressed following radiation therapy.
- Patients must be at least age 3 years but no older than 21 years of age.
- At least 4 weeks but no more than 14 weeks must have passed since completion of radiation therapy.