Neuroblastoma Clinical Trial
Official title:
PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
tumor-killing substances to them without harming normal cells. Combining colony-stimulating
factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for
advanced neuroblastoma.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus
sargramostim in treating patients who have advanced neuroblastoma.
OBJECTIVES:
- Define the antitumor effects of monoclonal antibody 3F8/sargramostim (3F8/GM-CSF) in
patients with advanced neuroblastoma.
- Assess the biological effects of 3F8/GM-CSF in these patients.
OUTLINE: Patients receive monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11 and
sargramostim (GM-CSF) IV over 2 hours on days -5 to 11. Treatment is repeated every 4 weeks
for up to 4 courses in the absence of progressive disease, HAMA response, or unacceptable
toxicity.
PROJECTED ACCRUAL: A total of 11-40 patients will be accrued for this study over 4 years.
;
Primary Purpose: Treatment
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