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Phase I Study of Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma

[Protocol 09-011]

Full Title :

PHASE I STUDY OF ANTI-GD2 3F8 ANTIBODY AND ALLOGENEIC NATURAL KILLER CELLS FOR HIGH-RISK NEUROBLASTOMA

Purpose :

The goal of this study is to see if it is safe and feasible to give chemotherapy (topotecan, cyclophosphamide, and vincristine), natural killer (NK) cells, and an antibody called 3F8 to patients with high-risk recurrent or persistent neuroblastoma.

The NK cells, a type of white blood cell, must come from a patient's relative who shares half of his or her HLA proteins, which are immune proteins important in transplantation. Studies have shown that NK cells from a donor can be given safely and can be helpful in treating some diseases. These NK cells are collected from the donor and purified.

NK cells can recognize and kill abnormal cells in the body and can work together with antibodies to kill target cells. The antibody 3F8 specifically recognizes a protein present on neuroblastoma cells. Researchers have already shown that the 3F8 antibody can be administered safely to neuroblastoma patients. They want to determine the effects of the combination of chemotherapy, NK cells, and 3F8 antibody on patients' cancers and bone marrow function, and how to maximize its benefits in treating cancer.

Eligibility :

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

• Patients must have a confirmed diagnosis of high-risk neuroblastoma that has persisted or progressed despite standard therapy.
• Patients must have a matched blood relative who can donate NK cells.

For more information about this study and to inquire about eligibility, please contact Dr. Shakeel Modak at 212-639-7623.