About this study
Neuroblastoma is a cancer that starts when nerve cells do not grow into healthy, normal cells. Instead, they get stuck at an early stage of growth, before they mature. The cells multiply when they should not, and this forms a tumor. The tumor shows up as a lump or mass in the body. It often spreads to the bone, liver, lymph nodes, and bone marrow before it is diagnosed.
Treatment for neuroblastoma may include chemotherapy, surgery, bone marrow transplant, radiation therapy, and immunotherapy. Some patients may have tumors that do not get smaller with treatment (refractory). In other patients, the cancer may disappear and then come back after treatment ends (relapse). Patients with neuroblastoma in these situations will often receive chemotherapy plus immunotherapy to make their cancer go away. In this case, the chemotherapy damages the cancer cells, and the immunotherapy makes the patient’s immune system fight the cancer cells.
The Food and Drug Administration (FDA) approved an immunotherapy medicine, called N-803, to treat bladder cancer in adults. This type of medicine has been used to treat neuroblastoma cells in a lab. In the lab, when the medicine was given with a combination of chemotherapy plus another immunotherapy medicine, the neuroblastoma cells disappeared.
In this study, HuNB803, doctors will see if N-803 can be given safely with chemotherapy plus immunotherapy to children with relapsed and refractory neuroblastoma. Once the combination is found to be safe to give, then doctors will see if N-803 plus chemotherapy and immunotherapy works better at treating neuroblastoma than chemotherapy plus immunotherapy alone.
This study may or may not help patients who take part in the study. What we learn from this study may help other children and young adults with neuroblastoma in the future.
Eligibility overview
- Relapsed or refractory neuroblastoma
- Up to age 30