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A Phase I Study of 3F8 Antibody plus Granulocyte-Macrophage Colony-Stimulating Factor in High-Risk Neuroblastoma
[Protocol 05-015]
- Full Title :
- 3F8 ANTIBODY DOSE ESCALATION PLUS GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR IN HIGH-RISK NEUROBLASTOMA: A PHASE I TRIAL
- 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 I study, investigators are assessing therapy with a monoclonal antibody called 3F8 in combination with a substance called granulocyte-macrophage colony-stimulating factor (GM-CSF), which can boost the power of the immune system to destroy the cancer cells. 3F8 has been used safely in many patients, and it has killed 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.
In this study, investigators want to determine the highest dose of 3F8 that can be used safely with GM-CSF while killing the neuroblastoma. An earlier study with lower doses of 3F8 and GM-CSF showed this regimen to be safe. Researchers are hoping that using a higher dose of 3F8 will also be safe.
- 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 neuroblastoma that has recurred or no longer responds to standard therapy.
- Prior treatment with 3F8 is permitted.
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.
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