Spots Global Cancer Trial Database for N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma

Study Description

Brief 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.

Detailed Description: OBJECTIVES: Primary * To establish the maximum tolerated dose of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) in patients with relapsed/refractory high-risk neuroblastoma. Secondary * To describe toxicity following treatment with \^131I-MIBG in patients with relapsed/refractory high-risk neuroblastoma. * To estimate radiation absorbed doses to measurable lesions and to a standard set of normal organs following a 0.1 mCi/kg \[3.7 MBq/kg\] (minimum dose of 1.0 mCi \[37 MBq\] but not to exceed 5.0 mCi \[185 MBq\]) intravenous administration of \^131I-MIBG in patients with relapsed/refractory high-risk neuroblastoma. * To describe, within the confines of a phase IIa trial, objective tumor response following treatment with \^131I-MIBG in patients with relapsed/refractory high-risk neuroblastoma. * To explore dose-response following treatment with \^131I-MIBG in patients with relapsed/refractory high-risk neuroblastoma. * To explore quality of life assessment following treatment with \^131I-MIBG in patients with relapsed/refractory high-risk neuroblastoma. OUTLINE: * Dosimetry: Patients receive a dosimetric dose of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) IV over 1-3 minutes. Patients then undergo 2 or 3 MIBG scans within 5 days of the dosimetry dose to assess biodistribution and tumor uptake. Patients with normal tumor uptake and biodistribution proceed to treatment. * Treatment: Within 1-4 weeks of the dosimetric dose, patients with normal tumor uptake and biodistribution receive a therapeutic dose of \^131I-MIBG IV over 1 hour on day 0 and undergo MIBG scan on day 7. Patients then proceed to autologous stem cell infusion. * Autologous stem cell infusion: Patients receive an infusion of autologous stem cells from peripheral blood or bone marrow on day 14. Patients with an ANC of \< 500/µl at any point after autologous stem cell infusion receive filgrastim (G-CSF) IV or subcutaneously once daily until ANC is \> 2,000/µl. Patients complete a quality of life questionnaire at baseline and then at day 60. After completion of study treatment, patients are followed at day 60 and periodically thereafter.

Keywords

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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