A Phase II Study of Hu3F8 plus GM-CSF to Prevent Osteosarcoma Recurrence

Full Title

A Phase II Study of Humanized Monoclonal Antibody 3F8 (Hu3F8) with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma

Purpose

3F8 is an antibody that attaches to a protein on cancer cells (including osteosarcoma cells) called GD2 and helps focus a patient's own immune system (especially white blood cells) to attack the cancer 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 is believed to make Hu3F8 more effective as well. The purpose of this study is to see if treatment with Hu3F8 plus GM-CSF can help patients with osteosarcoma that has been surgically removed to prevent the cancer from coming back.

Eligibility

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

  • This study is for patients between the ages of 1 and 40 years.
  • Patients must have recurrent osteosarcoma that has been surgically removed.
  • At least 3 weeks must pass between completion of prior therapies and entry into the study.

For more information and to inquire about eligibility for this study, please contact Dr. Alexander Chou at 212-639-6057.

Protocol

15-096

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Locations