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A Phase I Study of Intrathecal Radioimmunotherapy Using ¹³¹I-8H9 for Central Nervous System/Leptomeningeal Cancers

[Protocol 03-133]

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Full Title :

PHASE I STUDY OF INTRATHECAL RADIO IMMUNOTHERAPY USING 131I-8H9 FOR CENTRAL NERVOUS SYSTEM/LEPTOMENINGEAL NEOPLASMS

Purpose :

The purpose of this study is to find the highest safe dose of a new medicine, a radioactive antibody called ¹³¹I-8H9, in children and adults with cancer of the brain or brain covering (leptomeninges) that has returned after standard treatment or for which no standard therapy exists.

Antibodies are made by the body to fight infections, and in some cases, to fight tumors. The antibody 8H9 is made by mice and can attack many kinds of tumors. The medicine being evaluated in this study consists of 8H9 attached to radioactive iodine (¹³¹I). This drug has been given by vein to patients to see if it can find cancer cells. This is the first study assessing ¹³¹I-8H9 given into the spinal fluid ("intrathecally") to kill cancer cells.

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 cancer of the brain or brain covering (leptomeninges) that has returned after standard treatment or for which no standard therapy exists. The cancer must be confirmed to be reactive to 8H9.
• Patients may not have had radiation therapy to the head or spine or systemic chemotherapy within 3 weeks of entering the study.
• Both children and adults of any age are eligible to participate.

For more information and to inquire about eligibility for this study, please contact Dr. Kim Kramer at 212-639-6410.