Efficacy and Safety of Ultratrace™ Iobenguane I 131 in Neuroblastoma
This is a multi-center, single arm trial of two doses of 18 mCi/kg of Ultratrace iobenguane I 131 administered to subjects with high-risk neuroblastoma. Iobenguane I 131 is a drug that has already been used in many children to treat neuroblastoma, and it is known to shrink some of the tumors, and cause manageable side effects. When administered intravenously, Iobenguane I 131 accumulates in the neuroblastoma cancer cells and causes them to die.
In this study the investigators are investigating the use of a new form of Iobenguane I 131 called Ultratrace iobenguane I 131. This form is expected to deliver higher amounts of radioactive I 131 to the neuroblastoma cells. The primary purpose of the study is to determine if Ultratrace iobenguane I 131 can be used to successfully treat high-risk neuroblastoma. The study will also assess the safety of Ultratrace iobenguane I 131 when given to patients with high-risk neuroblastoma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2b Study Evaluating the Efficacy and Safety of Ultratrace™ Iobenguane I 131 Among Patients With Relapsed/Refractory High-Risk Neuroblastoma|
- Proportion of patients with complete or partial response, sustained over two assessments, following treatment. Response criteria for the primary endpoint are based on the International Neuroblastoma Response Criteria (INRC). [ Time Frame: Weeks 8, 16, 26, 39 and 52 after treatment ] [ Designated as safety issue: No ]
- Change in use of narcotics for pain management [ Time Frame: Weeks 8, 16, 26, 39 and 52 after treatment ] [ Designated as safety issue: No ]
- Change in patient quality of life [ Time Frame: Weeks 8, 16, 26, 39 and 52 after treatment ] [ Designated as safety issue: No ]
- Change in key tumor markers (HVA and VMA) [ Time Frame: Weeks 8, 16, 26, 39 and 52 after treatment ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Weeks 8, 16, 26, 39 and 52 after treatment ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Experimental: Ultratrace Iobenguane I 131||
Drug: Ultratrace Iobenguane I 131
Subjects will receive an Imaging Dose of 0.1 mCi/kg [3.7 MBq/kg] (a minimum dose of 1.0 mCi [37 MBq] but not to exceed 5.0 mCi [185 MBq]) of Ultratrace iobenguane I 131 to have dosimetry performed and to confirm tumor uptake of the test article prior to receiving each of 2 planned Therapeutic Doses of Ultratrace iobeneguane I 131 . Within 28 days of screening, eligible subjects (as confirmed by the first Imaging dose study)will receive an Ultratrace iobenguane I 131 Therapeutic dose of of 15.0 - 18.0 mCi/kg (max. 666 MBq/kg) followed by imaging 7 days later or upon discharge from radiation isolation. A second Therapeutic Dose (preceded by a repeat Image Dose and dosimetry study)and imaging upon discharge from radiation isolation will be repeated approximately 8 weeks after the first dose.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992173
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|Study Director:||Norman LaFrance, MD||Molecular Insight Pharmaceutical Employee|