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A Phase II Study of Anti-GD2 Antibody 3F8 and GM-CSF for High-Risk Neuroblastoma

[Protocol 03-077]

Full Title :

PHASE II STUDY OF ANTI-GD2 3F8 ANTIBODY AND GM-CSF FOR HIGH-RISK NEUROBLASTOMA

Purpose :

Neuroblastoma is a solid tumor that mainly affects young persons and can be very difficult to treat successfully. Although a combination of chemotherapy, radiation therapy, and surgery can help patients with advanced disease achieve remission, many patients experience a relapse of their disease. Because of this outcome, as well as the side effects associated with treatment, doctors are continually pursuing new, more effective and safer therapies.

In this phase II study, doctors at Memorial Sloan-Kettering are evaluating a treatment regimen for patients with neuroblastoma that is resistant to chemotherapy or radiation therapy. They are assessing therapy with a monoclonal antibody called 3F8 in combination with a substance called GM-CSF, which can boost the power of the immune system to destroy the cancer cells.

3F8 has been shown to kill cancer cells in some patients. 3F8 attaches to neuroblastoma cells and helps focus a patient's own immune system -- especially white blood cells -- to attack the neuroblastoma cells. Granulocytes make up one class of white blood cells. GM-CSF increases the number of granulocytes, and makes them better killers of cancer cells. The treatment is provided on an outpatient basis.

An earlier study with 3F8 and GM-CSF administered differently showed promising results In that study, GM-CSF was given intravenously. In this study, it will be given through an injection under the skin (subcutaneously). Investigators hope that this new way of giving these agents will be more effective by improving a patient's overall immune function, but they do not yet know if this will happen. The new treatment will also be easier to administer and could be made more widely available.

Eligibility :

To be eligible for this study, patients must have a confirmed diagnosis of neuroblastoma that is determined to be high-risk. They cannot have progressive disease. 3F8/GM-CSF is available for patients in complete remission after transplant and for patients whose neuroblastoma has not responded completely to other treatments.

For more information and to inquire about eligibility for this study, please contact Dr. Brian Kushner at 212-639-6793 or Dr. Nai-Kong V. Cheung at 212-639-8401, Monday through Friday from 9 AM to 5 PM, or at 212-639-7900 at all other times.