Expanded Access to Naxitamab and GM-CSF in People with High-Risk Neuroblastoma

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Full Title

Expanded Access Use of Naxitamab/GM-CSF Immunotherapy for Consolidation of Complete Remission or Relapsed/Refractory High-Risk Neuroblastoma

Purpose

3F8 is an agent (monoclonal antibody) that attaches to GD2, a marker on the surface of neuroblastoma cells. When that happens, it serves as a signal for a patient’s own immune system (especially white blood cells) to attack neuroblastoma cells. 3F8 is made from mouse cells. Humanized-3F8, also called naxitamab, is more like the human immune system and has many features that make it more effective in killing neuroblastoma cells. Because white blood cells are so important for fighting neuroblastoma, naxitamab is used with GM-CSF, This agent increases the number of white blood cells and makes them better killers of cancer cells, with the overall result being a greater antitumor effect.

The purpose of this study is to make treatment with naxitamab and GM-CSF available to patients with neuroblastoma that has returned (relapsed) after treatment or has a high risk of relapsing. This treatment is given on an outpatient basis, with naxitamab given intravenously (by vein) and GM-CSF given by injection under the skin.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have high-risk neuroblastoma.
  • Patients must have neuroblastoma that came back after treatment or is in complete remission with a high risk of returning.

For more information about this study and to inquire about eligibility, please contact Dr. Brian Kushner at 212-639-6793.

Protocol

20-227

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators