Neuroblastoma Clinical Trial
Official title:
A Phase 2a Study of Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma
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.
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.
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