RecruitingPhase 2NCT00107289

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

200 participants

Start Date

May 1, 2006

Study Type

INTERVENTIONAL

Conditions

Pheochromocytoma Neuroblastoma

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

Min Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This study is testing a radioactive treatment called MIBG (a targeted radiation therapy) in children and young adults with neuroblastoma or malignant adrenal gland tumors (pheochromocytoma or paraganglioma) that have come back or stopped responding to other treatments. **You may be eligible if...** - You have neuroblastoma (a childhood cancer) that is progressing, recurring, or has not responded to standard treatment - You have malignant pheochromocytoma or paraganglioma (rare adrenal/nerve tumors) and are between 1 and 21 years of age - The tumor is visible on MIBG scan (the scan used to target the treatment) - You have stem cells stored and available for use after treatment (for higher-dose therapy) - Your minimum life expectancy is at least 8 weeks - You are over 1 year of age **You may NOT be eligible if...** - You have severe organ damage (kidney, heart, liver, lung, or gut) at grade 3 or higher - You have an active serious infection not controlled by antibiotics - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGiobenguane I 131

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.