A Phase II Study of Hu3F8/GM-CSF plus Isotretinoin in Patients with High-Risk Neuroblastoma in First Remission

Full Title

Hu3F8/GM-CSF Immunotherapy Plus Isotretinoin for Consolidation of First Remission of Patients with High-Risk Neuroblastoma: A Phase II Study

Purpose

The purpose of this study is to assess the effectiveness of treatment with Hu3F8, GM-CSF, and isotretinoin in patients who have achieved a first remission (no evidence of cancer) after initial neuroblastoma therapy and who have a high risk of the cancer returning. Isotretinoin is made from vitamin A and has been shown to prevent relapse in some patients with neuroblastoma.

3F8 is an 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) is made to be more like the human immune system than a mouse’s immune system, so it may be associated with fewer side effects in patients than standard mouse-derived 3F8.

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 has been shown to make mouse 3F8 more effective against neuroblastoma, and it is believed to make Hu3F8 more effective as well.

Eligibility

Patients in this study must have high-risk neuroblastoma in first remission.

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

Protocol

16-1643

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases