Neuroblastoma Treatment Guided by Biology-Based Risk Factors – Phase III

Protocol Description

The purpose of this Children's Oncology Group study is to see if babies and young toddlers with a non-high-risk neuroblastoma can be treated without surgery or by reducing chemotherapy, based on certain biology-based risk factors. The current standard of care includes surgery alone or surgery followed by chemotherapy, both of which introduce certain risk factors.

Study Level: III

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling patients diagnosed with a non-high-risk neuroblastoma. Patients must be less than 12 months old at the time of diagnosis with a stage L1 tumor as defined by the International Neuroblastoma Risk Group (INRG), and they must be less than 18 months of age if diagnosed with INRG stage L2 or stage Ms (metastatic) neuroblastoma/ganglioneuroblastoma.
Boys and Girls: Under 12 months of age or under 18 months of age, depending on tumor type as noted above

Requirements

Participants will be placed in one of the study’s two treatment groups based on the participant’s age and factors such as the tumor’s size, stage, location, and biologic features. Depending on the treatment group, researchers will use observation, such as tests, scans, and a symptom scoring system to determine when and if a surgical or chemotherapy intervention is needed.
Visits: Number varies by treatment group.
Duration: Varies by treatment group and can be either about 2 years or about 3 years for most participants.

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ANBL1232)
National Cancer Institute

Additional Information

Study Description at the National Institutes of Health
Cancer and Blood Disorder Research 

Primary Investigator

Jean M. Tersak, MD

Contact Information

For more information about the study or enrollment, please contact the UPMC Children’s Hospital of Pittsburgh Hematology-Oncology research team, at: HOCHPPhaseI-II@upmc.edu