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Results summary of St. Jude clinical trial: 



Neuroblastoma Protocol 2012: Therapy for Children with Advanced Stage High-Risk Neuroblastoma (NB2012)

Why was this study done?

Neuroblastoma is the most common solid tumor (outside of the brain) in children. It is a cancer of nerve cells that shows up as a lump or mass in the abdomen, chest, neck or pelvis. In nearly half of children with neuroblastoma, the tumor has spread to other body parts, such as the bones, liver, lymph nodes and bone marrow.

This study was done as part of a larger study. Scientists wanted to find out if adding a new drug called hu14.18K322A to two cycles of standard induction chemotherapy (chemo) would result in better tumor responses than standard chemo only.

Hu14.18K322A is a monoclonal antibody, a protein made in a lab. This protein is designed to bind to cancer cells that have on their surface a molecule called the GD2 antigen. Almost all neuroblastoma tumor cells have the GD2 antigen on their surface. When hu14.18K322A binds to the neuroblastoma cells, it tells the immune system to attack and kill the cancer cells without harming nearby healthy cells. Some patients also received treatment with natural killer cells. Natural killer (NK) cells are immune system cells that help fight cancer as well as viral-infected cells.

In this study blood and bone marrow samples were also collected to better understand how hu14.18K322A works when given with chemo.

The study’s main goals were to:

  • find out if a new treatment combination with hu14.18K322A antibody was safe and resulted in better tumor response when paired with two cycles of standard induction chemo
  • find out how natural killer cells behaved in the body in the presence of chemo and the antibody

When was this study done?

The study opened in May 2013 and closed to accrual in October 2019.

What did the study consist of?

Patients had tests that included:

  • A physical exam, including height and weight measurements
  • Blood and urine tests
  • Bone marrow biopsy and aspirate
  • A pregnancy test for females
  • Scans such as X-rays, CT, MRI and MIBG tests
  • Tests of kidney function
  • EKG to check the heart’s electrical activity
  • Echocardiogram to test the heart’s function
  • Hearing tests
  • Eye exam

Patients were treated with the antibody hu14.18K322A and chemotherapy. Some patients also received the natural killer cells treatment.

What did we learn from this study?

Patients tolerated the treatment well, and we saw tumors shrink. Ninety-seven percent of patients had partial or better responses to the first 2 courses of chemo and antibody. The 3-year event-free survival rate was 74%. Adding the natural killer cells to the patients tolerated treatment was safe.

What are the next research steps as a result of this study?

Future studies are needed to confirm these findings and the role of combining chemo and immune therapy for children with neuroblastoma.

How does this study affect my child?

How does this study affect my child?

Every childhood cancer survivor should have long-term follow-up care. In the St. Jude After Completion of Care clinic, we will give your child information and guidance for care after treatment. Please speak with your St. Jude doctor about specific guidelines for your child.

For more information

Please talk with your child’s St. Jude doctor about questions or concerns you have as a result of this study.

Publications generated from this study:

A Phase II Trial of Hu14.18K322A in Combination with Induction Chemotherapy in Children with Newly Diagnosed High-Risk Neuroblastoma. Furman WL, Federico SM, McCarville MB, Shulkin BL, Davidoff AM, Krasin MJ, Sahr N, Sykes A, Jianrong W, Brennan RC, Bishop MW, Helmig S, Stewart E, Navid F, Triplett B, Santana VM, Bahrami A, Anthony G, Yu AL, Hank J, Gillies SD, Sondel PM, Leung WH, Pappo AS. Clin Cas Res. 2019 Nov; 25 (21):6320-28. Doi: 10.1158/1078-0432.CCR-19-1452. Epub 2019 Oct 10. PMID: 31601569; PMCID: PMC6825564.

Longitudinal NK Cell Kinetics and Cytotoxicity in Children with Neuroblastoma Enrolled in a Clinical Phase II Trial. Nguyen R, Sahr N, Sykes A, McCarville MB, Federico SM, Sooter A, Cullins D, Rooney B, Janssen WE, Talleur AC, Triplett BM, Anthony G, Dyer MA, Pappo AS, Leung WH, Furman WL. J Immunother Cancer. 2020 Mar;8(1):e000176. Doi: 10.1136/jitc-2019-000176. PMID: 32221013; PMCID: PMC7206969.

Improved Outcome in Children with Newly Diagnosed High-Risk Neuroblastoma Treated with Chemoimmunotherapy: Updated Results of a Phase II Study Using hu14.18K322A. Furman WL, McCarville B, Shulkin BL, Davidoff A, Krasin M, Hsu CW, Pan H, Wu J, Brennan R, Bishop MW, Helmig S, Stewart E, Navid F, Triplett B, Santana V, Santiago T, Hank JA, Gillies SD, Yu A, Sondel PM, Leung WH, Pappo A, Federico SM. J Clin Oncol. 2022 Feb 1;40(4):335-344. Epub 2021 Dec 6.: