OPTIMUM (MIBG 2014-01) is a Phase II, single-arm, non-randomized, open-label study of therapeutic 131I-iobenguane (131I-MIBG) for the treatment of neuroblastoma. The study will be conducted in male and female subjects, greater than 1 year of age, with iobenguane avid, relapsed, high-risk neuroblastoma.
Subjects will receive 18 mCi/kg of 131I-MIBG intravenously, and if the subject qualifies, the subject will receive the second 18 mCi/kg 131I-MIBG treatment (no sooner than 6 weeks following the first therapeutic 131I-MIBG treatment). Subject must have an overall response of stable disease or better, as assessed by the Investigator, and meet certain predefined criteria to receive the second treatment.
Following a screening period of up to 4 weeks, the duration in the study treatment phase for an individual subject, who receives two treatments, is up to 22 weeks. For an individual subject, who receives one treatment only, the duration of the treatment phase is 16 weeks. In addition, there is a 2-year follow-up after the treatment phase, during which assessments will be performed to assess disease progression, as well as record adverse events.
MIBG 2014-01: A Phase II Single-arm Study of Therapeutic Iobenguane (131-I) for Relapsed, High-risk Neuroblastoma Subjects.