This family protocol summary provides a general overview of the Children’s Oncology Group (COG) study ANBL09P1. It tells who is eligible and gives basic information about the study. More details about the study are in the consent form and protocol. You can get these from your oncologist.

ANBL09P1 is a pilot study. The purpose of this pilot study is to learn if a new treatment, when added to the standard therapy, is practical and can be successfully completed without unacceptable toxicity in many hospitals around the country. This study (clinical trial) is a therapeutic clinical trial. That means it is done to learn about treatment – its safety and how well it works. In this study, patients receive standard therapy plus a new treatment that was found to be safe and effective in other therapeutic trials. We are determining which dose of the new treatment is best when combined with standard therapy and whether the additional treatment creates any additional costs or hardships for families if they have to travel to another hospital for the additional therapy.

It is important to understand that participating in a clinical trial is entirely voluntary. The decision about whether or not to participate will not affect the care provided by the health care team in any way. You can find additional information about participation in clinical trials at Always discuss any questions that you may have with your health care team.

Study Number


Official Title

A COG Pilot Study of Intensive Induction Chemotherapy and 131I-MIBG Followed by Myeloablative Busulfan/Melphalan (Bu/Mel) for Newly Diagnosed High-Risk Neuroblastoma

Study Opening Date

ANBL09P1 opened on October 4, 2010. The ANBL09P1 committee hopes to enroll 105 patients. The study closed on 12/24/2015.

General Patient Eligibility

Please consult your doctor to determine whether your child may participate in this study.

General Background and Study Goal

High-Risk Neuroblastoma is a childhood cancer that is often hard to cure; therefore additional therapies are needed. The main goal of this study is to determine if a new therapy, called 131I-Metaiodobenzylguanidine (131I-MIBG) is feasible (reasonable) to add to the standard therapy for High-Risk neuroblastoma. MIBG is a chemical agent taken up by neuroblastoma tumor cells. MIBG can be combined together with radioactive iodine (131I) in the laboratory to make the radioactive drug 131I-MIBG. The 131I-MIBG delivers radiation directly to the neuroblastoma cancer cells and causes them to die.

Summary of the Treatment

The current standard therapy for High-Risk neuroblastoma includes 3 phases of therapy: Induction, Consolidation, and Maintenance. Each phase of therapy has multiple components. In this study, the last cycle of chemotherapy during the induction phase will be replaced with 131I-MIBG therapy.

Induction Phase

Consolidation Phase

ANBL09P1 therapy is complete following radiation therapy.

A maintenance phase of therapy is typically given following consolidation therapy. The goal is to kill any remaining neuroblastoma cells. Your doctor will discuss further treatment plans with you.

Special Considerations

Risks and Side Effects

Chemotherapy can cause side effects during and after treatment. All patients will be closely monitored for possible side effects of the medicines. All risks and side effects will be explained by your treatment team during the consent process. They can answer any questions that you may have about giving permission for your child to be in the clinical trial or other aspects of care. Please refer to the consent form for a detailed explanation of the side effects associated with the treatment on this study.

Contact Information

Your child’s oncologist and nurses are the best sources for further information.

Study Chairs

Brian Weiss, MD
Cincinnati Children’s Hospital Medical Center


Initial development Name Date
Written by Wendy Fitzgerald, RN, MSN 4/28/2015
Reviewed/approved by (PI) Brian Weiss, MD 1/14/2016
Ongoing review
Reviewed and updated by

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