Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
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ClinicalTrials.gov Identifier: NCT00107289 |
Recruitment Status :
Recruiting
First Posted : April 6, 2005
Last Update Posted : July 3, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuroblastoma Pheochromocytoma | Radiation: iobenguane I 131 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open Access Protocol of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors |
Actual Study Start Date : | May 2006 |
Estimated Primary Completion Date : | May 2020 |
Estimated Study Completion Date : | May 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Radiation |
Radiation: iobenguane I 131
Patients receive a single dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over 30 minutes to 4 hours 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 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. |
- Response (complete or partial) [ Time Frame: 2 years ]
- Correlation between tumor self-absorbed dose and response and tumor volume decrease [ Time Frame: 2 years ]

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Ages Eligible for Study: | 1 Year and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 with a determination that radiation safety restrictions during therapy period can be implemented.
- 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.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107289
Contact: Ellen Basu, MD, PhD | 212-639-5204 | ||
Contact: Shakeel Modak, MD | 212-639-7623 |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Ellen Basu, MD, PhD 212-639-5204 | |
Contact: Shakeel Modak, MD 212-639-7623 | |
Principal Investigator: Ellen Basu, MD, PhD |
Principal Investigator: | Ellen Basu, MD, PhD | Memorial Sloan Kettering Cancer Center |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00107289 History of Changes |
Other Study ID Numbers: |
04-148 MSKCC-04148 |
First Posted: | April 6, 2005 Key Record Dates |
Last Update Posted: | July 3, 2019 |
Last Verified: | July 2019 |
metastatic pheochromocytoma recurrent pheochromocytoma regional pheochromocytoma recurrent neuroblastoma 04-148 |
Neuroblastoma Pheochromocytoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Paraganglioma Neuroendocrine Tumors 3-Iodobenzylguanidine Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Radiopharmaceuticals |