MIBG Upfront Research

Cook Children's is pleased to be participating with Children's Oncology Group (COG) and National Cancer Institute (NCI) in ANBL 1531, a partially randomized phase III trial that studies I-131-MIBG or crizotinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as I-131-MIBG, are designed to carry radiation directly to tumor cells without harming normal ones. Crizotinib may stop the growth of ALK aberrant tumor cells by blocking some of the enzymes needed for cell growth. Giving I-131-MIBG or crizotinib and standard therapy may work better in treating younger patients with neuroblastoma or ganglioneuroblastoma, giving more hope to patients and their families.

Upfront therapy for neuroblastoma patients: ANBL1531: A Phase 3 Study of I-131-Metaiodobenzylguanidine (I-131-MIBG) or Crizotinib Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL).

Who can participate in this trial?

Participants in this trial are newly diagnosed high-risk neuroblastoma or ganglioneuroblastoma patients ages 1 to 30 years.

Objectives for MIBG in Upfront Clinical Trials

I-MIBG has the potential to improve event free survival (EFS) rate in children with chemoresistant disease. Initial trials indicate intensification of consolidation therapy (sequential high dose chemotherapy) with autologous stem cell rescue improves outcomes. In this trial, we will study if giving MIBG earlier in therapy is advantageous to neuroblastoma patients.

How does the trial work?

In this trial there are two types of patient groups, or ARMS: randomized and assigned.

Randomized ARMS

Arm A treatment: COG recommended therapy with tandem transplant
Arm B treatment: COG recommended therapy + I-131-MIBG during Induction with tandem transplant.
Arm C treatment: COG recommended therapy + I-131-MIBG during Induction and single stem cell transplant with BuMel (Busulfan and Melphalan) during Consolidation.

Assigned ARMS

Arm D treatment: COG recommended therapy with tandem transplant(for MIBG NON-avid patients without ALK aberration).
Arm E treatment: COG recommended therapy with tandem transplant with Crizotinib (for patients with ALK aberration).

Improving cancer outcomes through research

As key collaborators with the nation's leading pediatric research organizations, we offer the best available treatments and actively contribute to the search for a cure. Our ultimate goal is to erase kid cancer.

Meet our principal investigator

M. Meaghan Granger, M.D., specializes in treating Neuroblastoma patients and is very active in research. Get to know Dr. Granger and see what research programs she is currently active in. Get to know Dr. Granger and see what research programs she is currently active in.

Questions about MIBG research?

Contact Cook Children's Neuroblastoma Program Clinical Coordinator at 682-885-4017.

Active neuroblastoma research studies

A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 erbumine as a Single Agent and in Combination in Patients with Relapsed/Refractory Neuroblastoma

Primary Investigator: M. Meaghan Granger

IRB ID: 2020-018 (OPEN)

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A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab with or without Eflornithine (DFMO) (IND# 141913) in Children with Relapsed, Refractory or Progressive Neuroblastoma

Primary Investigator: M. Meaghan Granger

IRB ID: 2019-049 (OPEN)

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An Open-Label, Expanded Access Protocol Using 131-I-Metaiodobenzylguanidine (131 I-MIBG) Therapy in Patients with Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma

Primary Investigator: M. Meaghan Granger

IRB ID: 2012-026 (OPEN)

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Iobenguane I-131 or Crizotinib and Standard Therapy in Treating Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma or Ganglioneuroblastoma

Primary Investigator: M. Meaghan Granger

IRB ID: 2018-048 (TEMPORARILY CLOSED TO ACCRUAL)

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MIBG 2014-01, A Phase II Single-Arm Study of Therapeutic Iobenguane (131I) for High-Risk Neuroblastoma Subjects at the Time of First Relapse

Primary Investigator: M. Meaghan Granger

IRB ID: 2018-079 (OPEN)

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NANT 2013-01: Immunotherapy of Relapsed Neuroblastoma with Expanded NK Cells, Lenalidomide, and ch14.18

Primary Investigator: M. Meaghan Granger

IRB ID: 2018-050 (OPEN)

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NANT 2015-02: Phase 1 Study of Lorlatinib (PF-06463922), An Oral Small Molecula Inhibitor of ALK/ROS1, for Patients with ALK-Driven Relapsed or Refractory Neuroblastoma

Primary Investigator: M. Meaghan Granger

IRB ID: 2017-022 (OPEN)

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NANT 2017-01: A Phase I Study of 131I-MIBG with Dinutuximab for Relapsed/Refractory Neuroblastoma

Primary Investigator: M. Meaghan Granger

IRB ID: 2018-032 (OPEN)

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Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma

Primary Investigator: M. Meaghan Granger

IRB ID: 2015-032 (OPEN)

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