A Phase 2 Study of Reduced Chemotherapy and Antibody-Based Therapy in Children With Neuroblastoma

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Full Title

N10: Reduced Therapy for High-Risk Neuroblastoma

Purpose

Researchers are assessing a new combination therapy for neuroblastoma that has a high chance of coming back after treatment. This study is for children with high-risk neuroblastoma who have not gotten more than 1 chemotherapy cycle.

The drug combination is called N10 and includes various chemotherapy drugs that are very effective at killing neuroblastoma.  N10 also includes immunotherapy: treatment with agent called naxitamab. This drug is a monoclonal antibody that gets the child’s own white blood cells to kill neuroblastoma. 

The number of different drugs in N10 may make it less likely that the cancer will become resistant to chemotherapy. Researchers also think that N10 may have fewer side effects on the body than the usual treatment for high-risk neuroblastoma. Examples of these side effects include hearing problems and effects on major organs, such as the heart.

If your child joins this study, they will get 3 different combinations of chemotherapy drugs given at different times:

  • Cycles 1 and 4: Cyclophosphamide, topotecan, and vincristine
  • Cycle 2: Ifosfamide, carboplatin, and etoposide
  • Cycle 3: Cyclophosphamide, doxorubicin, and vincristine

After cycle 3, your child will have some stem cells removed (blood-forming cells) as part of their usual care. They will also have surgery to remove the tumor.

After cycle 4, they will have 2 cycles of treatments that include naxitamab and GM-CSF. GM-CSF makes white blood cells better killers of neuroblastoma. Between these 2 cycles, they will have radiation therapy. Your child’s doctor might give other medications as well, depending on how well your child’s cancer responds to the treatment.

Who Can Join

To join this study, there are a few conditions. Your child must:

  • Have high-risk neuroblastoma that has not been treated with more than 1 cycle of chemotherapy.
  • Be under age 19 years.

Contact

For more information and to see if your child can join this study, please call 833-MSK-KIDS (833-675-5437).

Protocol

24-144

Phase

Phase II (phase 2)

Investigator

Co-Investigators

Diseases