NCT00083135

N2000-01: Double Infusion of Iodine I 131 Metaiodobenzylguanidine Followed by Autologous Stem Cell Transplantation

I-MIBG Escalating Dose Rapid Sequence Double Infusion Followed By Autologous Stem Cell Infusion For Refractory Neuroblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: New Approaches to Neuroblastoma Therapy Consortium · Academic / Other
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Giving iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) may kill neuroblastoma cells by delivering radiation directly to the tumor. A stem cell transplant using the patient's stem cells may be able to replace blood-forming cells destroyed by radiation therapy. PURPOSE: This phase I trial is studying the side effects and best dose of a double infusion of \^131I-MIBG followed by autologous stem cell transplantation in treating patients with refractory neuroblastoma.

Detailed description

OBJECTIVES: Primary * Determine the maximum tolerated red marrow radiation dose delivered and associated toxic effects of escalating activity of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) followed by autologous hematopoietic stem cell transplantation in patients with refractory neuroblastoma. * Determine the number of days after stem cell transplantation to achieve absolute neutrophil count ≥ 500/mm\^3 for 3 days and platelet count ≥ 20,000/mm\^3 for 3 days (without transfusions) in patients treated with this regimen. Secondary * Determine the response rate in patients treated with this regimen, based on lesions measurable by CT or MRI at study entry, patients with \^131I-MIBG scan-positive lesions only, and patients with minimal residual tumor in bone marrow who have complete response by immunocytology and morphology. * Determine the tumor absorbed radiation dose in patients with measurable soft tissue lesions treated with this regimen. * Correlate, if possible, TP53 mutations with response in patients with accessible bone marrow tumor treated with \^131I-MIBG. OUTLINE: This is a dose-escalation, multicenter study. * Iodine I 131 metaiodobenzylguanidine (131I-MIBG) therapy: Patients receive\^131I-MIBG IV over 2 hours on days 0 and 14. Cohorts of 3-6 patients receive escalating doses of \^131I-MIBG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * Stem cell transplantation therapy: Patients undergo autologous peripheral blood stem cell transplantation on day 28. Patients receive filgrastim (G-CSF) IV over 1 hour OR subcutaneously daily beginning on day 28 and continuing until blood counts recover. Patients are followed every 3 months for 1 year and then annually thereafter. PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study within 2 years.

Conditions

• Neuroblastoma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
PROCEDURE	autologous bone marrow transplantation
PROCEDURE	peripheral blood stem cell transplantation
RADIATION	iobenguane I 131

Timeline

• Start date: 2004-03-01
• Primary completion: 2006-02-01
• First posted: 2004-05-17
• Last updated: 2026-04-14

Locations

7 sites across 1 country: United States