Home › Neuroblastoma › NCT00107289
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
RecruitingPhase 2
Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors
Who can join
Ages 1 and older · All sexes
Full eligibility criteria
Inclusion criteria for NB: * 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. Inclusion criteria for malignant CCT: * 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 Criteria: * 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. * Inability or unwillingness to comply with radiation safety procedures or protocol requirements.
About the study
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.
What is being tested
- iobenguane I 131 (drug)
Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 200 · Started: 2006-05
Contact the study team
- Ellen Basu, MD, PhD · Phone: 212-639-5204
- Shakeel Modak, MD · Phone: 212-639-7623
Official record on ClinicalTrials.gov — NCT00107289
Locations in the U.S.
| New York | Memorial Sloan Kettering Cancer Center, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.