Efficacy and Safety of Ultratrace™ Iobenguane I 131 in Neuroblastoma
- Registration Number
- NCT00992173
- Lead Sponsor
- Molecular Insight Pharmaceuticals, Inc.
- 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
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ultratrace Iobenguane I 131 Ultratrace Iobenguane I 131 -
- Primary Outcome Measures
Name Time Method 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). Weeks 8, 16, 26, 39 and 52 after treatment
- Secondary Outcome Measures
Name Time Method Change in use of narcotics for pain management Weeks 8, 16, 26, 39 and 52 after treatment Change in key tumor markers (HVA and VMA) Weeks 8, 16, 26, 39 and 52 after treatment Change in patient quality of life Weeks 8, 16, 26, 39 and 52 after treatment Overall survival Weeks 8, 16, 26, 39 and 52 after treatment
Trial Locations
- Locations (21)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
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
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
University of Wisconsin Medical Center
🇺🇸Madison, Wisconsin, United States
Texas Childrens Hospital Cancer Center
🇺🇸Houston, Texas, United States
Cook Children's Healthcare System
🇺🇸Fort Worth, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada