What this study is
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's being tested
- iobenguane I 131
Intervention · DRUG
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.
Study details
- Official title
- Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Neuroblastoma · Pheochromocytoma
- Enrolling
- 200 people
- Starts
- 2006-05
- Est. completion
- 2027-05
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Year and overSex ALLHealthy volunteers Not acceptedInclusion 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.
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Study locations (1)
1 openMemorial Sloan Kettering Cancer Center
New York, New York, United States
- Ellen Basu, MD, PhD · Contact212-639-5204
- Shakeel Modak, MD · Contact212-639-7623
- Ellen Basu, MD, PhD · Principal investigator
Recruiting
Study team
Sponsor
Memorial Sloan Kettering Cancer Center
Study ID 04-148
Principal investigator
Ellen Basu, MD, PhD
Memorial Sloan Kettering Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.