NCT00107289PHASE2Recruiting
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
Memorial Sloan Kettering Cancer Center
Start Date
5/1/2006
Completion Date
5/1/2027
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.
Eligibility Criteria
Age Range: 1 years to No maximum
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.
Interventions
DRUG
iobenguane I 131
Conditions
NeuroblastomaPheochromocytoma
Locations
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States