A Phase II Study of Immunotherapy in Patients with Recurrent or Persistent Neuroblastoma Affecting the Bone or Bone Marrow

Full Title

A Pivotal Phase 2 Trial of Antibody hu3F8 and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients with Primary or Secondary Refractory Osteomedullary Disease

Purpose

3F8 is a monoclonal antibody that attaches to neuroblastoma cells and helps focus a patient’s own immune system (especially white blood cells) to attack neuroblastoma cells. Conventional 3F8 is made from mouse cells. Humanized 3F8 (Hu3F8, also called naxitamab) is made to be more like the human immune system and has many features that promise to make it more effective in killing neuroblastoma cells.

GM-CSF is a protein that increases the number of white blood cells and may make them better able to kill cancer cells. GM-CSF may also make Hu3F8 more effective. The purpose of this study is to assess the safety and effectiveness of Hu3F8 plus GM-CSF in patients with neuroblastoma that has persisted or returned despite prior treatment and is present in the bone or bone marrow.

Hu3F8 is given intravenously (by vein) and GM-CSF is 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 neuroblastoma that has persisted or returned despite prior treatment and is affecting the bone or bone marrow.
  • This study is open to patients over age 1 year.
  • At least 3 weeks must have passed since completion of prior chemotherapy or immunotherapy and entry into the study.
  • Prior treatment with 3F8 or any other monoclonal antibody used against neuroblastoma is permitted.

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

Protocol

18-375

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases