Iodine I 131 Metaiodobenzylguanidine and a Stem Cell Transplant in Treating Young Patients With Relapsed or Refractory High-Risk Neuroblastoma

Official Title

A Phase I Study Of UltratraceTM Iobenguane I 131 In Patients With Relapsed/Refractory High-Risk Neuroblastoma

Summary:

Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIBG), may carry radiation directly to tumour 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.

This phase I 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.

Trial Description

Primary Outcome:

• Maximum tolerated dose

• Toxicity
• Estimation of radiation absorbed doses to measurable lesions
• Objective tumour response after treatment
• Dose response after treatment
• Quality of life

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 I trial, objective tumour 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.

• Dosimetry: Patients receive a dosimetric dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 2-3 minutes. Patients then undergo 2 or 3 MIBG scans within 5 days of the dosimetry dose to assess biodistribution and tumour uptake. Patients with normal tumour uptake and biodistribution proceed to treatment.
• Treatment: Within 1-4 weeks of the dosimetric dose, patients with normal tumour 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 allogeneic stem cell infusion.
• Allogeneic 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.

View this trial on ClinicalTrials.gov