Medical and R&D



Study 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 of the Study

To determine the efficacy and safety of 131I-MIBG treatment in combination with vorinostat in subjects with iobenguane avid, recurrent or progressive high-risk neuroblastoma.

Protocol Summary

The study is conducted in the United States and will include up to 70 high-risk neuroblastoma patients. Eligible patients will receive up to two cycles of vorinostat, once daily for 14 days, and 131I-MIBG treatment (as a single infusion per cycle).

Participation in the study may involve up to 14 visits over a 2 1/2-year period, depending on the number of treatment cycles received and the response to treatment.

Basic Eligibility Criteria

  • Patients 1 year of age or older
  • Diagnosis of iobenguane avid high-risk neuroblastoma
  • Refractory, recurrent or progressive disease
  • May have had prior 131I-MIBG therapy

Sites Participating in the Study

  • Dana-Farber/Boston Children’s Cancer and Blood Disorders Center (Boston, MA)
  • Northwell Health (Long Island, NY)
  • Children's Hospital of Philadelphia (Philadelphia, PA)
  • UPMC Children’s Hospital of Pittsburgh (Pittsburgh, PA)
  • Atrium Health (Charlotte, NC)
  • Nemours Children’s Health (Jacksonville, FL)
  • Cincinnati Children's Hospital Medical Center (Cincinnati, OH)
  • University of Wisconsin, American Family Children’s Hospital (Madison, WI)
  • University of Chicago (Chicago, IL)
  • University of Iowa (Iowa City, IA)
  • Washington Univ. Medical Center St. Louis (St Louis, MO)
  • University of Minnesota (Minneapolis, MN)
  • Cook Children's Health Care System (Fort Worth, TX)
  • Children’s Health (Dallas, TX)
  • Texas Children's Hospital (Houston, TX)
  • Children’s Hospital Colorado (Aurora, CO)
  • University of California (San Francisco, CA)
  • Seattle Children's Hospital (Seattle, WA)

For more detailed information about the study and contact information of participating
sites, refer to (NCT03561259)

Or Communicate with Jubilant at

About High-Risk Neuroblastoma

High-risk neuroblastoma is a difficult to treat childhood cancer and those children with resistant or relapsed disease, after current treatment options are exhausted, have poor prognosis.

Jubilant Radiopharma is proud to be a leader in the development of therapeutics intended to treat rare and serious conditions including neuroblastoma. These efforts are aligned with the value that nuclear medicine can bring to improve precise, patient-focused treatment.

NOTE: Therapeutic MIBG labeled with I-131 is not approved by the USFDA or Health Canada


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