Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors
Memorial Sloan Kettering Cancer Center
200 participants
May 1, 2006
INTERVENTIONAL
Conditions
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
Inclusion Criteria16
- 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 Criteria4
- 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
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT00107289