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.

Questions about MIBG research?

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