N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Intervention: UltratraceTM Iobenguane I 131 Imaging; UltratraceTM Iobenguane I 131 Therapy
Intervention description: 0.1 mCi/kg [3.7 MBq/kg] (minimum dose 1mCi [37MBq] but not to exceed 5 mCi [185 MBq]) of UltratraceTM Iobenguane I 131 given 7 -28 days before therapeutic dose administration on day 0. Thyroid protection will be administered per institutional protocol for I-131-MIBG however, thyroid blocking must be started prior to the Ultratrace imaging dose. Anterior and posterior whole body images will be taken to assess organ distribution, tumor uptake and dosimetry calculations.; Therapeutic dose will be given on Day 0 if dosimetry scans showed that the prescribed or adjusted dose will not exceed > 23 Gy to the kidneys, > 30 Gy to the liver, or > 15 Gy to the lungs. and tumor uptake confirmed with UltratraceTM imaging dose. Only one treatment course of therapeutic UltratraceTM will be given in this study.
Intervention MeSH terms: 3-Iodobenzylguanidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Ultratrace™ Iobenguane I 131
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 1 Year
Maximum age: 30 Years
Healthy volunteers: No
Keywords: recurrent neuroblastoma

Summary:

      RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry
      radiation directly to tumor cells and not harm normal cells. A bone marrow or peripheral stem
      cell transplant using stem cells from the patient may be able to replace blood-forming cells
      that were destroyed by I 131 MIBG.

      PURPOSE: This phase II trial is studying the side effects and best dose of iodine I 131 MIBG
      followed by a stem cell transplant in treating young patients with relapsed or refractory
      high-risk neuroblastoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be at least one year and no more than 30 years of age when registered on
             this study.

          -  Patients must have high risk neuroblastoma and either have tumor left after treatment
             started at diagnosis or have had the tumor grow back (relapsed) after getting some
             treatment

          -  Patients must an MIBG scan done and it must be positive for neuroblastoma.

          -  Patients must have a PBSC or bone marrow stem cell product available that meets study
             criteria. If they don't already have stem cells frozen away then they must be able to
             have a stem cell pheresis done to collect the necessary amount of stem cells for study
             entry and these stem cells must meet study criteria.

          -  Patients must have adequate heart, lung, liver, kidney and bone marrow function.

        Exclusion Criteria:

          -  They have had a stem cell transplant using another person as the stem cell donor. (You
             can still be in the study if a previous transplant used your own stem cells)

          -  They have other medical problems that could get much worse if they had this treatment.

          -  They are on dialysis for badly working kidneys or have other kidney problems.

          -  They are pregnant or breast feeding.

          -  They have tumor in the brain or spinal cord that is seen on a CT or MRI scan one month
             before starting treatment

          -  They had total body radiation or radiation to the entire belly.

          -  They have a known allergy to MIBG, iodine or SSKI.

          -  They can't cooperate with the special precautions that are needed during UltratraceTM
             MIBG treatment or with other safety monitoring requirements of the study..