Full TitlePhase II Study of Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) Chemoimmunotherapy for High-Risk Neuroblastoma
The purpose of this study is to assess the effectiveness of chemoimmunotherapy with Hu3F8, GM-CSF, irinotecan, and temozolomide in patients with high-risk neuroblastoma that has come back or continued to grow despite treatment.
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.
Irinotecan and temozolomide are both used to treat neuroblastoma that has come back or persisted despite initial treatment. These drugs have been assessed with GM-CSF and another antibody that has the same target as Hu3F8, and were shown to be effective against neuroblastoma. Irinotecan and Hu3F8 are given intravenously (by vein), GM-CSF is given as an injection, and temozolomide is taken orally (by mouth).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have high-risk neuroblastoma that has come back or continued to grow despite treatment.
- This study is open to patients of all ages.
For more information about this study and to inquire about eligibility, please contact Dr. Shakeel Modak at 212-639-7623.