Clinical Trials Office

131-I-MIBG Expanded Access: An Open Label, Expanded Access Protocol Using I-Metaiodobenzylguanidine (131I-MIBG) Therapy in Patients With Refractory Neuroblastoma

What is the purpose of this study?

  • Provide palliative therapy with MIBG for patients with advanced neuroblastoma
  • Gain more information about acute and late toxicity of 131I-MIBG therapy for patients with refractory neuroblastoma

Who can participate?

  • Refractory or relapsed neuroblastoma with original diagnosis based on tumor histopathology or elevated urine catecholamines with typical tumor cells in the bone marrow
  • Failure to respond to standard therapy (usually combination chemotherapy with or without radiation and surgery) or development of progressive disease at any time (any new lesion or an increase in size of >25% of a pre-existing lesion). Disease evaluable by MIBG scan must be present within 8 weeks of study entry and subsequent to any intervening therapy. If patient has received prior treatment with MIBG, they must have a response or stable disease after the most recent MIBG infusion.

Conditions

  • Adult Studies
  • Cancer - Neuroblastoma
  • Medications

What is involved?

This research study will continue to evaluate the side effects of 131I-MIBG when treating children and adults with neuroblastoma.

  • The 131I-MIBG compound is intended to work by selectively delivering the radioactive iodine to the cancer cells, which is then intended to result in their destruction.
  • One treatment cycle of 131I-MIBG therapy is 7 to 9 weeks long. The patient will be evaluated to receive additional 131I-MIBG therapy at the end of each cycle. If they qualify and their blood counts are good, it is possible that they could receive a total of three treatment cycles, for a total of 21 to 27 weeks. Hospitalization is required for approximately 3-5 days after each dose.

Who should I contact for more information?

Cincinnati Children’s Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org

Where can I find additional information?