A Phase 1 interventional study of filgrastim and autologous bone marrow transplantation in Neuroblastoma, sponsored by New Approaches to Neuroblastoma Therapy Consortium. Completed at 7 sites in United States. Open to participants aged 1 Year to 30 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by New Approaches to Neuroblastoma Therapy Consortium · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, multicenter study.
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.
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.
625 studies on the registry are indexed under Neuroblastoma; 123 are open to participants now.
This study's planned enrollment of 18 is below the median of 32 across 475 interventional studies indexed under Neuroblastoma.
Browse Neuroblastoma studies →New Approaches to Neuroblastoma Therapy Consortium is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of neuroblastoma
Confirmed by at least 1 of the following methods:
High-risk disease
Poor response to induction therapy OR relapse defined by any of the following:
Must meet the following criteria for minimum number of autologous stem cells:
Unpurged peripheral blood stem cells (PBSC)
PBSC purged with immunomagnetic beads
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
New Approaches to Neuroblastoma Therapy Consortium