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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) Protocol Number: MIBG 2014-01
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Recruiting
This will be a Phase II, two-arm, nonrandomized, non-comparative, open-label study in participants ≥ 1 year of age with iobenguane avid, recurrent or progressive high-risk neuroblastoma. Participants not eligible for vorinostat treatment may receive 131I-MIBG as monotherapy.
Male or Female
Not specified
Inclusion Criteria:
• at least 1 year old
• diagnosis of iobenguane avid, high-risk neuroblastoma, with recurrent or progressive disease at any time
• frontline therapy includes a minimum of 4 cycles of induction therapy at any time
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:
• less than 12 weeks after myeloablative therapy with autologous stem cell transplant
• receiving hemodialysis
• women who are pregnant or breastfeeding
• significant active infections including active hepatitis B, or hepatitis C infection, or known infection with human immunodeficiency virus (HIV)
Cancer
Neoplasms, Neuroblastoma, Neuroectodermal Tumors
Allison Fullenkamp - fulle631@umn.edu
Emily Greengard
Phase 2
STUDY00005792
See this study on ClinicalTrials.gov