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ANBL1232 Study to Guide Therapy Non-High-Risk Neuroblastoma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to figure out which children need treatment and what the best treatment is for newly diagnosed neuroblastoma.

What is the Condition Being Studied?

Non-High Risk Neuroblastoma

Who Can Participate in the Study?

Children with newly diagnosed neuroblastoma who

Group A: Are less than 12 months old with newly diagnosed Stage L1 neuroblastoma.

Group B: Children who are less than 18 months old with newly diagnosed Stage L2 neuroblastoma.

Group C: Children who are less than 18 months old with newly diagnosed Stage Ms neuroblastoma.

No prior radiotherapy or chemotherapy, except dexamethasone, is allowed.
Children must not have had surgery to remove the primary tumor.

Age Group
Children

What is Involved?

If you choose to have your child this study, he or she will be put into a group based on certain features of their disease.

Group A is for children younger than one year old with newly diagnosed Stage L1 neuroblastoma
Subjects will be closely observed and will not have a biopsy or surgery on this trial.

Group B is for children younger than 18 months old with newly diagnosed Stage L2 neuroblastoma
Instead of starting treatment at diagnosis, these children will be closely monitored for tumor growth or spread. They may go on to have chemotherapy and/or have surgery if the tumor grows.

Group C is for children younger than 18 months with newly diagnosed Stage Ms neuroblastoma
Children who are very young and those with symptoms or unfavorable tumor features will start chemotherapy sooner than usual.

We will use a symptom scoring system to decide when to stop chemotherapy for all children who go on to have chemotherapy.

Study Details

Full Title
ANBL1232 Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma
Principal Investigator
Pediatric Hematology-Oncology Specialist
Protocol Number
IRB:PRO00059254
NCT:NCT02176967
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698