Efficacy and Safety of Ultratrace™ Iobenguane I 131 in Neuroblastoma

Withdrawn before enrolling · Phase 2

Conditions studied: Neuroblastoma

In brief

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.

Key facts

Study ID

NCT00992173

Run by

Molecular Insight Pharmaceuticals, Inc.

People needed

0

Starts

2010-01-01

Last updated by the study team

2015-11-26

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients will be excluded if any of the following conditions are observed:
• Pregnant, or lactating females with the intent to breast feed. Females of child-bearing potential must have a negative serum pregnancy test prior to therapy. Males and females of reproductive age and childbearing potential must use effective contraception defined as abstinence or use of IUD, oral contraceptive, barrier and spermicide, or hormonal implant for the duration of their participation. Sexually active female patients using oral contraception will be required to use a second form of barrier birth control. All patients will be required to use effective contraception for 60 days following the last therapeutic dose of Ultratrace iobenguane I 131.
• Have disease of any major organ system that would compromise their ability to withstand therapy.
• Receiving hemodialysis or have a renal obstruction, which would effect the urinary excretion of MIBG.
• Is platelet transfusion dependent
• Status post-allogeneic hematopoietic stem cell transplant.
• Concomitant use of medications that inhibit uptake of Ultratrace iobenguane I 131.
• Have a known allergy to iobenguane, iodine or SSKI.
• If patients and/or families who are physically and psychologically unable to cooperate with the radiation safety isolation or imaging requirements (sedation or general anesthesia permitted).
• Administered prior chemotherapy within 30 days of study entry or have active malignancy (other than neuroblastoma) requiring additional treatment.
• Any other condition, that in the opinion of the investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study.
• Patient unable to receive at least one 15 mCi/kg dose per dosimetry findings.

Where it is running

• 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

Full record on ClinicalTrials.gov

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