Neuroblastoma Clinical Trial
Official title:
A Phase 2b Study Evaluating the Efficacy and Safety of Ultratrace™ Iobenguane I 131 Among Patients With Relapsed/Refractory High-Risk Neuroblastoma
This is a multi-center, single arm trial of two doses of 18 mCi/kg of Ultratrace iobenguane
I 131 administered to subjects with high-risk neuroblastoma. Iobenguane I 131 is a drug that
has already been used in many children to treat neuroblastoma, and it is known to shrink
some of the tumors, and cause manageable side effects. When administered intravenously,
Iobenguane I 131 accumulates in the neuroblastoma cancer cells and causes them to die.
In this study the investigators are investigating the use of a new form of Iobenguane I 131
called Ultratrace iobenguane I 131. This form is expected to deliver higher amounts of
radioactive I 131 to the neuroblastoma cells. The primary purpose of the study is to
determine if Ultratrace iobenguane I 131 can be used to successfully treat high-risk
neuroblastoma. The study will also assess the safety of Ultratrace iobenguane I 131 when
given to patients with high-risk neuroblastoma.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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