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Brief Title: A Study of Therapeutic Iobenguane (131-I) and Vorinostat for Recurrent or Progressive High-Risk Neuroblastoma Subjects
Official 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)
Study ID: NCT03561259
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of 131I-MIBG in combination with Vorinostat in patients with Recurrent or Progressive neuroblastoma
Detailed Description: OPTIMUM (MIBG 2014-01) is a Phase II, Two arm, non-randomized, open-label study of therapeutic 131I-iobenguane (131I-MIBG) as single agent or in combination with Vorinostat for the treatment of neuroblastoma. The study will be conducted in male and female subjects, greater than 1 year of age, with iobenguane avid, who have recurrent or progressive disease, regardless of overall response to frontline therapy, where frontline therapy includes a minimum of 4 cycles of induction therapy at any time prior to enrollment, high-risk neuroblastoma. Subjects who are eligible for combination treatment will receive vorinostat 180 mg/m2/dose (maximum dose 400 mg) once daily for 14 days (Day -1 to Day 12) continuously. Subjects will receive 18 mCi/kg of 131I-MIBG intravenously on Day 1. If the subject qualifies, the subject will receive the second treatment course of 131I-MIBG in combination with vorinostat or 131I-MIBG alone (no sooner than 6 weeks following first treatment course). 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 course of 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 26 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.
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford University, Palo Alto, California, United States
UCSF Pediatric Hematology/Oncology, San Francisco, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Nemours Children's Specialty Care, Jacksonville, Florida, United States
University of Chicago Medical Center, Chicago, Illinois, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Minnesota, Minneapolis, Minnesota, United States
Washington University Medical Center in St. Louis, Saint Louis, Missouri, United States
Northwell Health /Cohen Children's Medical Center, New Hyde Park, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Carolinas Medical Center/Levine Children's Hospital (Atrium Health), Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center, Children's Health, Dallas, Texas, United States
Cook Children's Hematology/Oncology Center, Fort Worth, Texas, United States
Texas Children's Hospital, Houston, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
University of Wisconsin, American Family Children's Hospital and Clinical Science Center, Madison, Wisconsin, United States
Name: Melda Dolan
Affiliation: Jubilant DraxImage Inc., dba Jubilant Radiopharma
Role: STUDY_DIRECTOR