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
Phase
II
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 inquire about eligibility for this study, please contact Dr. Kim Kramer at 212-639-6410.

Disease(s)
Brain Tumors, Metastatic
Brain Tumors, Primary
Brain Tumors, Primary: Brain Metastases
Pediatric Brain Tumors: Brain Cancer
Pediatric Brain Tumors: CNS Cancer
Locations