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

[Protocol 05-122]

Full Title :

PHASE II STUDY OF INTRATHECAL 131I-3F8 IN PATIENTS WITH GD2-EXPRESSING CENTRAL NERVOUS SYSTEM AND LEPTOMENINGEAL NEOPLASMS

Purpose :

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.

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 a brain or spinal cord cancer known to express the GD2 protein.
• Patients must have tumors that do not respond to conventional therapy or for which no conventional therapy exists.
• At least 3 weeks must have passed since completion of any prior chemotherapy.
• This study is open to patients of any age (both children and adults).

For more information and to see if you are eligible for this study, please contact Dr. Kim Kramer at 212-639-6410.