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Spots Global Cancer Trial Database for A Study of Therapeutic Iobenguane (131-I) and Vorinostat for Recurrent or Progressive High-Risk Neuroblastoma Subjects

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Melda Dolan

Affiliation: Jubilant DraxImage Inc., dba Jubilant Radiopharma

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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