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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-04148 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation | Experimental | Patients will be treated with IV 131I-MIBG using 1-2 high dose(s) or up to 16 low doses. Thyroid protection is commenced seven days (+/-2 days) prior to administration of 131I-MIBG and continued for up to 42 days after each 131I-MIBG treatment. Given that this is an open access protocol, re-enrollment is allowed per PI discretion. Patients who received this treatment previously are allowed to be re-enrolled if they meet the eligibility criteria. Re-enrollment can be to the same arm previously treated on (high dose versus low dose) or to the other arm. Patients will not be eligible for re-enrollment if they have already received 16 low doses or 4 high doses of 131I-MIBG. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iobenguane I 131 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Response (complete or partial) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between tumor self-absorbed dose and response and tumor volume decrease | 2 years |
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Inclusion criteria for NB:
Inclusion criteria for malignant CCT:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ellen Basu, MD, PhD | Contact | 212-639-5204 | ||
| Shakeel Modak, MD | Contact | 212-639-7623 |
| Name | Affiliation | Role |
|---|---|---|
| Ellen Basu, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26773712 | Derived | Chu BP, Horan C, Basu E, Dauer L, Williamson M, Carrasquillo JA, Pandit-Taskar N, Modak S. Feasibility of Administering High-Dose (131) I-MIBG Therapy to Children with High-Risk Neuroblastoma Without Lead-Lined Rooms. Pediatr Blood Cancer. 2016 May;63(5):801-7. doi: 10.1002/pbc.25892. Epub 2016 Jan 15. | |
| 26742708 | Derived |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| Modak S, Zanzonico P, Carrasquillo JA, Kushner BH, Kramer K, Cheung NK, Larson SM, Pandit-Taskar N. Arsenic Trioxide as a Radiation Sensitizer for 131I-Metaiodobenzylguanidine Therapy: Results of a Phase II Study. J Nucl Med. 2016 Feb;57(2):231-7. doi: 10.2967/jnumed.115.161752. Epub 2016 Jan 7. |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| D010673 | Pheochromocytoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D010235 | Paraganglioma |
| D018358 | Neuroendocrine Tumors |
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| ID | Term |
|---|---|
| D019797 | 3-Iodobenzylguanidine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D007462 | Iodobenzenes |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D006847 | Hydrocarbons, Iodinated |
| D006846 | Hydrocarbons, Halogenated |
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