A Study of Therapeutic Iobenguane (131-I) for Relapsed, High-Risk Neuroblastoma Subjects (OPTIMUM)
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|ClinicalTrials.gov Identifier: NCT03561259|
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma Neuroectodermal Tumors Neoplasms||Drug: 131I-MIBG||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm, non-randomized, open-label study.|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Single-arm Study of Therapeutic Iobenguane (131-I) for Relapsed, High-risk Neuroblastoma Subjects|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2023|
Subjects will receive 18 mCi/kg of 131I-MIBG administered via either a central or a peripheral intravenous catheter over 1.5 to 2 hours on Day 0. The maximum absolute dose of 131I-MIBG on this protocol is determined by institution therapeutic limits and will not exceed 1,000 mCi. Subjects with an overall response of stable disease or better as assessed by the Investigator, and who meet certain predefined criteria, may receive a second 18 mCi/kg 131I-MIBG treatment no sooner than 6 weeks following the first therapeutic 131I-MIBG treatment.
- Overall Response [ Time Frame: 6 weeks after the last 131I-MIBG treatment and a confirmatory assessment at least 6 weeks thereafter (at least 12 weeks from the end of treatment) ]Overall response (Yes/No) is based on the International Neuroblastoma Response Crtieria (INRC, published 2017). The INRC will be calculated based on 123I-iobenguane scans, CT/MRI, and bone marrow biopsies and aspirates. A "Yes" is defined as complete response, partial response or minor response. A "No" response is defined as stable disease or progressive disease.
- Overall Response at 6 weeks after 131I-MIBG treatment [ Time Frame: 6 weeks after the last 131I-MIBG treatment (first or second treatment). ]
- Durability of Effect of Overall Response (Yes/No) [ Time Frame: For all tumour assessment data collected throughout the study (up to the end of the 2-year follow-up). ]
- Relative Curie Extension Score [ Time Frame: 6 weeks after the last 131I-MIBG treatment. ]
- Durability of Effect of Relative Curie Extension Score [ Time Frame: For all tumour assessment data collected throughout the study (up to the end of the 2-year follow-up). ]
- Incidence of Adverse Events (CTCAE Version 5.0) [ Time Frame: Up to 22 weeks ]
- Incidence of Serious Adverse Events [ Time Frame: Through study completion, up to 2.5 years. ]
- Whole Body Radiation Dose [ Time Frame: After each 131I-MIBG treatment for up to 120 hours. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561259
|Contact: Norman LaFrance, MD,FACP||267-475-2192||MIBGclinicaltrials@jdi.jubl.com|
|Contact: Margaret E Hurley, MD,FRAPS||(908) 273-8490||MIBG-OPTIMUM-Trial@hurleyconsulting.com|
|United States, Colorado|
|Children's Hospital Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Astrid Eder 720-777-8531 email@example.com|
|Principal Investigator: Margaret Macy, MD|
|United States, Texas|
|University of Texas Southwestern Medical Center, Children's Health||Recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Beverly Kleiber, PhD, CCRP 214-456-1003 firstname.lastname@example.org|
|Principal Investigator: Tanya Watt, MD|
|United States, Washington|
|Seattle Children's Hospital||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Laura Hill 206-884-3002 email@example.com|
|Principal Investigator: Navin Pinto, MD|
|Study Director:||Norman LaFrance, MD,FACP||Jubilant DraxImage Inc.|
|Study Director:||Alexandre Brkovic, PhD||Jubilant DraxImage Inc.|