A Phase II Study of Intrathecal I131-3F8 in Patients with GD2-Expressing Central Nervous System and Leptomeningeal Neoplasms

Malignant tumors in the brain and/or spinal cord are life-threatening. Radiation therapy is often helpful in controlling tumor growth. This study is evaluating a new medication that delivers focused radiation to tumor cells. The purpose of this research study is to investigate whether multiple injections of this drug will be safe and effective in controlling malignant tumors of the brain and/or spinal cord.

The drug, an antibody called 3F8, is a protein that attaches to tumor cells. When radioactive iodine is attached to the antibody, it is referred to as I¹³¹-3F8. When I¹³¹-3F8 attaches to a tumor, it delivers radiation directly to the tumor. The I¹³¹-3F8 is put into an Ommaya reservoir, a permanent small plastic tube placed in one of the ventricles of the patient’s brain by a neurosurgeon.

Before the I¹³¹-3F8 injection, patients will receive a variety of other medications to protect the thyroid gland from the radioactivity and to prevent allergic reactions and fever.