Spots Global Cancer Trial Database for Efficacy and Safety of Ultratrace™ Iobenguane I 131 in Neuroblastoma
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Trial Identification
Brief Title: Efficacy and Safety of Ultratrace™ Iobenguane I 131 in Neuroblastoma
Official Title: A Phase 2b Study Evaluating the Efficacy and Safety of Ultratrace™ Iobenguane I 131 Among Patients With Relapsed/Refractory High-Risk Neuroblastoma
Study ID: NCT00992173
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 12 Months
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital of LA, Los Angeles, California, United States
UCSF Pediatric Hematology/Oncology, San Francisco, California, United States
University of Miami Miller School of Medicine, Miami, Florida, United States
Childrens Memorial/Northwestern University, Chicago, Illinois, United States
Comer's Childrens Hospital/University of Chicago, Chicago, Illinois, United States
University of iowa, Iowa City, Iowa, United States
Johns Hopkins University, Baltimore, Maryland, United States
Children's Hospital/Dana Farber Cancer Institute, Boston, Massachusetts, United States
CS Motts Children's Hospital, Ann Arbor, Michigan, United States
Mount Sinai School of Medicine, New York, New York, United States
Hospital - Weill Cornell Medical Center, New York, New York, United States
Memorial Sloan Kettering, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Cincinnati Children's Hospital, Cincinnati, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Cook Children's Healthcare System, Fort Worth, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Texas Childrens Hospital Cancer Center, Houston, Texas, United States
University of Wisconsin Medical Center, Madison, Wisconsin, United States
The Hospital for Sick Children, Toronto, Ontario, Canada
Contact Details
Name: Norman LaFrance, MD
Affiliation: Molecular Insight Pharmaceutical Employee
Role: STUDY_DIRECTOR
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