Ignite Creation Date:
2024-05-05 @ 9:56 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00992173
Status:
WITHDRAWN
Last Update Posted:
2015-11-26
First Post:
2009-10-07
Brief Title:
Efficacy and Safety of Ultratrace Iobenguane I 131 in Neuroblastoma
Sponsor:
Molecular Insight Pharmaceuticals Inc
Organization:
Molecular Insight Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 2b Study Evaluating the Efficacy and Safety of Ultratrace Iobenguane I 131 Among Patients With RelapsedRefractory High-Risk Neuroblastoma
Status:
WITHDRAWN
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center single arm trial of two doses of 18 mCikg 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None