A Phase II Study of 131I-MIBG Alone or with Vorinostat in People with High-Risk Neuroblastoma

Full Title

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)

Purpose

High-risk neuroblastoma has a high chance of coming back or resisting standard treatment. In this study, researchers are assessing the safety and effectiveness of ¹³¹I-MIBG alone or in combination with vorinostat in people with high-risk neuroblastoma. ¹³¹I-MIBG is a type of radiation therapy used to target and kill cancer cells. ¹³¹I-MIBG is radioactive iodine and gives off radiation to destroy cancer cells. When it is attached to a chemical called MIBG, MIBG brings radiation into the tumor.

Vorinostat is a chemotherapy drug that works by attacking neuroblastoma cells and stopping them from growing. Giving vorinostat together with ¹³¹I-MIBG may increase the amount of radiation that reaches the tumor to kill cancer cells. ¹³¹I-MIBG is given intravenously (by vein) and vorinostat is taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

• Participants must have high-risk neuroblastoma.
• Prior treatment with 131I-MIBG is permitted as long as it ended at least 6 months before the study treatment is given and was not given with another anticancer drug.
• This study is for people age 1 year and older.

Contact

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.