Tests radioactive iodine I-131 MIBG in hard-to-treat neuroblastoma and related tumors
Tests radioactive iodine I-131 MIBG in children and adults with resistant neuroblastoma or pheochromocytoma.
Plain-language title generated from the registry record
Registry title: Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
Key facts
- Where
- New York, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Memorial Sloan Kettering Cancer Center
- Trial code
- NCT00107289
- Record updated
- 29 May 2026
- Original description
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.Read full original descriptionShow less
Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors
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.
Inclusion: Patients must have the diagnosis of NB in accordance with the International Criteria, i.e., either histopathology (confirmed by the MSKCC Department of Pathology) or BM involvement plus elevated urinary catecholamines; Must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy; Patients must have MIBG-avid NB and evaluable disease on MIBG scan at time of enrollment on protocol; Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy; Age >1 year; Determination that radiation safety restrictions during therapy period can be implemented; Stem cells: Patients for high does must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. Patients for low dose do not require cryopreserved autologous hematopoietic stem cell product available. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg; Minimum life expectancy of eight weeks; Signed informed consent indicating awareness of the investigational nature of this program; Patients must have the diagnosis of malignant CCT i.e. malignant pheochromocytoma or malignant paraganglioma; Patients must have MIBG-avid malignant CCT and evaluable disease on MIBG scan at time of enrollment on protocol; Prior Therapy: At least 2 weeks should have elapsed since any biologic therapy. Three weeks should have elapsed since last dose of chemotherapy; Age between 1 and 21 years and able to cooperate with radiation safety restrictions during therapy period; Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. The minimum dose for peripheral blood stem cells is 2 X106 CD34+ cells/kg; Minimum life expectancy of eight weeks; Signed informed consent indicating awareness of the investigational nature of this program.
Exclusion: Inability or unwillingness to comply with radiation safety procedures or protocol requirements; Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 2 or less. A grade 3 hearing deficit is acceptable; Active serious infections not controlled by antibiotics; Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.