SC-4009, A PHASE II OPEN LABEL, TWO-ARM STUDY OF THERAPEUTIC IOBENGUANE (131I) AS SINGLE AGENT OR IN COMBINATION WITH VORINOSTAT FOR RECURRENT OR PROGRESSIVE HIGH-RISK NEUROBLASTOMA SUBJECTS (OPTIMUM TRIAL)
What is the goal of the study?
This study is being done to provide data to show if Iobenguane (131I) (which is also known as MIBG 131I) in combination with vorinostat is effective in the treatment of patients with neuroblastoma. The study is also being done to further determine how safe MIBG 131I is in combination with vorinostat by looking at side effects of patients in this study. Neuroblastoma is a type of tumor that develops in nerve cells outside of the brain. It usually shows up as a mass or lump in the abdomen or around the spinal cord in the chest, neck, or pelvis. Metaiodobenzylguanidine (MIBG) is a substance that is taken up by neuroblastoma cells. JDI has combined MIBG with radioactive iodine (131I) in the laboratory to form MIBG 131I. Since MIBG is taken up by neuroblastoma cells, it is possible that the radiation can reach the tumors and can radiate and kill the cells. Vorinostat, under the brand name ZOLINZA, has been granted approval by the U.S. FDA in 2006 for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies in adults.Vorinostat is currently not approved for the treatment of neuroblastoma in children and is used under this IND as an investigational treatment.
Who can participate in the study?
Please contact the study team listed below to learn more.