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Protocol No. PO10312

Principal Investigator DeSantes, Kenneth

Phase Pilot/Feasibility

Age Group Both

Scope Local

Sponsor Type Industry

Title An open label, expanded access protocol using 131I-Metaiodobenzylguanidine (131I-MIBG) Therapy in Patients with Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma

Objective The purpose of this research study is to:
  • Make 1311-MIBG therapy available to patients with advanced neuroblastoma, pheochromocytoma, or paraganglioma
  • Further assess the side effects of 131 I-MIBG therapy

Treatment The therapy in this study involves getting a new drug called 131 I-MIBG which is radioactive. This drug has not been approved by the FDA (Food and Drug Administration) and it has not been determined to be effective. 131 I-MIBG takes radiation directly to tumor cells and it is hoped that it will cause them to die

Description The study will last about 9 weeks and involves one dose of the study drug. Depending on the dose that your doctor decides to use, this may be followed by a stem cell transplant. Your child will be in the hospital for about 5 days while he/she is radioactive. Because the experimental drug is radioactive, your child will be kept in a room with lead shields. You will only be allowed to see your child from behind the lead shield. You will only be able to touch your child for short periods of time for the first 4-5 days to protect you from the radiation. Your child will be able to see and talk to you and you them at all times using a two-way video camera.

After your child has been treated with the 131 I-MIBG and is no longer radioactive, he/she will be discharged from the hospital. He/She will need to come back to have an MIBG scan and lab work done.

If your child has the stem cell transplant, he/she will come back on day 13 and get his/her stem cells. The stem cells will be given either in clinic or in the hospital because your child will need to get 6 hours of fluid along with the stem cells.

Your child will be evaluated to receive additional 131 I-MIBG therapy at the end of each cycle. If he/she qualifies and his/her blood counts are good, it is possible that your child could receive a total of three treatment cycles.

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Key Eligibility
  • Refractory or relapsed neuroblastoma OR pheochromocytoma or paraganglioma not amenable to curative surgery
  • 12 mos or older
  • Failure to respond to standard chemotherapy or development of progressive disease at any time
  • Patients with known MIBG-avid parenchymal brain metastases are not eligible.
  • (Patients with leptomeningeal or skull-based metastases are eligible.)

Applicable Disease Sites Neuroblastoma

Therapies Involved Other

Drugs Involved I - MIBG Metaiodobenzylguanidine; Ultratrace (I - MIBG Metaiodobenzylguanidine)

Status Open

Participating Institutions UW Hospital and Clinics