The purpose of this study is to test the feasibility and toxicity of administering intrathecal immunotherapy for patients with central nervous system/leptomeningeal (CNS/LM) malignancies.
This is a phase I study, where the purpose is to find a safe dose of a new medicine called antibody 8H9. 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. 8H9 antibody can have a dose of radiation attached to it called 131-I. 131I-8H9 has been given in the vein to patients to find cancer cells. This is the first study using 131I-8H9 in the fluid in the spine to kill cancer cells. 131-I is a beta emitting isotope used extensively for radiation targeted therapies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
177
Patients will be injected, intrathecally, with 2 mCi 131I-Omburtamab during week 1 of a 5 week cycle.
The dose used in this study is 50 mCi 131IOmburtamab, (averaging 5 mCi/mg Omburtamab at 50 mCi dose) which will be administered to each patient during week 2 of a 5 week cycle.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Number of patients that have treatment related toxicities
Assessment of patient with treatment related toxicities
Time frame: 2 years
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