Pilot Phase II Study of Targeted Radiotherapy With I-metaiodobenzylguanidine (I-MIBG) in Patients With Resistant Neuroblastoma or Malignant Chromaffin Cell Tumors
- Utilize targeted radiotherapy using iodine I 131 metaiodobenzylguanidine (^131I-MIBG)
in treating patients with recurrent, progressive, or refractory neuroblastoma (NB) or
malignant chromaffin cell tumors (CCT).
- Determine the response rate in patients with NB treated with this regimen.
- Determine, preliminarily, the toxicity and efficacy of this regimen in patients with
- Determine the whole-body dosimetry of ^131I-MIBG in these patients.
- Determine the tumor dosimetry of ^131I-MIBG in patients with measurable soft tissue
OUTLINE: This is an open-label, pilot study.
Patients receive a single dose of iodine I 131 metaiodobenzylguanidine (^131I-MIBG) IV over
1-4 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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response (complete or partial)
Shakeel Modak, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|