At a glance
ClinicalIndex Comparison Record- ✓Histopathologically confirmed neuroblastoma or bone marrow involvement plus elevated urinary catecholamines
- ✓History of tumor progression, recurrence, or failure to achieve complete response with standard therapy
- ✓MIBG-avid disease with evaluable disease on MIBG scan at enrollment
- ✓Age >1 year (NB); age 1-21 years (malignant CCT)
- ✕Grade 3 or higher major organ toxicity (renal, cardiac, hepatic, pulmonary, gastrointestinal, neurologic; grade 3 hearing deficit acceptable)
- ✕Active serious infections not controlled by antibiotics
- ✕Pregnancy or inadequate contraception
- ✕Inability or unwillingness to comply with radiation safety procedures or protocol requirements
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors
In Brief
A Phase 2 clinical trial evaluating iobenguane I 131 for Neuroblastoma and Pheochromocytoma. Currently recruiting, targeting 200 participants across 1 site.
Detailed Summary
The purpose of this research study is to find how active and safe 131 I-MIBG is in patients with resistant neuroblastoma, malignant pheochromocytoma and malignant paraganglioma.
Study Details
Timeline
Interventions
A single dose of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) IV over 30 minutes to 4 hours or for 15 minutes for smaller patients on day 0. Patients undergo radiation dosimetry following the first dose of \^131I-MIBG to determine if a second dose can be safely administered. Some patients may receive a second dose of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) 6-8 weeks after the first dose. In some scenarios, extended time will be allowed before the second dose of 131I-MIBG for additional recovery and possible bridging therapy. If response is achieved and patients do not experience major toxicity. After blood radioactivity has fallen below 1 μCi/mL, patients may undergo autologous stem cell transplantation. After completion of study treatment, patients are followed at 4-6 weeks after \^131I-MIBG administration and then every 3 months for up to 1 year. Once patients are off treatment on this protocol, they will begin long term follow up through 5 years from enrollment.