About this study
Neuroblastoma is a cancer that often affects young children. Sometimes the cancer does not respond to treatment or comes back after treatment. When this happens, doctors need better treatments to help children live longer.
This study tests a new treatment for children and young adults with neuroblastoma that has not responded to treatment or has come back. This treatment includes:
- Chemotherapy drugs called temozolomide and irinotecan
- An immotherapy medicine called dinutuximab
- An immune system medicine called GM-CSF
- Special immune cells called natural killer (NK) cells
The NK cells come from healthy donors and are grown in a lab to help them work better. Researchers hope these cells can help kill cancer cells.
Patients get chemotherapy for 5 days. Dinutuximab is given on days 2–5. If patients tolerate the treatment, they get donor NK cells on day 8. Patients may repeat this treatment up to 6 times. Researchers watch closely for side effects and signs that the cancer is getting smaller or staying the same.
Patients are followed for many years after treatment. Researchers want to learn if adding donor NK cells helps the treatment work better and how safe the treatment is. They also want to learn how long the NK cells stay in the body, how they affect the immune system, and what side effects may happen. This information may help improve treatment for children and young adults with neuroblastoma that is hard to treat.
Eligibility overview
- Age 1–31 years
- Has neuroblastoma that did not respond to treatment or has come back
- The neuroblastoma can be seen on scans, in the bone marrow, or in tissue samples
- Has recovered from earlier treatment side effects
- Meets organ function and blood count requirements