Efficacy and Safety of Ultratrace™ Iobenguane I 131 in Neuroblastoma

Inclusion Criteria

• •1. Males or females who are \>12 months of age
• •2. Have a diagnosis of neuroblastoma either by (a) histologic verification of neuroblastoma and/or (b) demonstration of tumor cells in the bone marrow with increased urinary catecholamine metabolites
• •3. Have high-risk neuroblastoma with relapsed/refractory disease at any time.
• •4. MIBG avid disease demonstrated by 131I or 123I -MIBG uptake into tumor at ≥ one site within 28 days prior to study treatment and no intervention/therapy between the time of the MIBG scan and study treatment.
• •5. To be eligible to receive at least one therapeutic dose, patients must have adequate banked autologous stem cells defined as:
• •PBSC: A minimum of 2.0 x 106 viable CD34+ cells/kg (purged or unpurged) (see Section 10.4.15)
• •6. Prior Therapy:
• •1. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. There is no limitation on the number of prior chemotherapeutic regimens that the patient may have received.
• •2. The last dose of all local palliative radiation must be ≥ 14 days prior to the first therapeutic dose of Ultratrace iobenguane I 131. Any lesion treated with local palliative radiation during this period can not be included in the baseline target lesion evaluation.
• •3. The last dose of all local palliative radiation to more than 25% of marrow containing bones must be ≥ 28 days prior to the first therapeutic dose of Ultratrace iobenguane I 131. A minimum of 3 months is required following prior large field radiation therapy (i.e. craniospinal therapy, total lung, \> 50% marrow space). Note: Radiation therapy of focal skull-based bony metastatic disease (only) is not considered craniospinal therapy.
• •4. The last dose of any myelosuppressive or biologic (e.g., isotretinoin \[also known as cis-retinoic acid, or Accutane®\]) therapy must be at least 14 days before the administration of the first therapeutic dose of Ultratrace iobenguane I 131 on this protocol.
• •5. The last dose of immunotherapy must be at least 28 days prior to the first therapeutic dose of Ultratrace iobenguane I 131.
• •6. All cytokines or hematopoietic growth factors must be discontinued for a minimum of 7 days prior to the first therapeutic dose of Ultratrace iobenguane I 131or 14 days prior to the first therapeutic dose of Ultratrace iobenguane I 131for long-acting colony stimulating factors.
• •7. Prior treatment with 131I-MIBG therapy must be ≥12 months prior to the first therapeutic dose of Ultratrace iobenguane I 131.
• •8. Administration of Neuroblastoma therapeutic investigational medication or devices must be ≥30 days prior to dosimetry dose.
• •9. Prior autologous stem cell infusion must be ≥2 months prior to study entry. The patient must have recovered from all toxicities
• •7. Adequate Organ Function:
• •1. Adequate bone marrow function requirements, including patients post-myeloablative therapy or tumor involvement of bone marrow
• •2. Adequate renal, hepatic, cardiac, lung and thyroid function