Neuroblastoma Clinical Trial
Official title:
3F8 Antibody Dose Escalation Plus Granulocyte-Macrophage Colony-Stimulating Factor in High-Risk Neuroblastoma: A Phase I Trial
RATIONALE: Monoclonal antibodies, such as 3F8, can block tumor growth in different ways.
Some block the ability of tumor cells to grow and spread. Others find tumor cells and help
kill them or carry tumor-killing substances to them. Colony-stimulating factors, such as
GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood.
Giving monoclonal antibody therapy together with GM-CSF may be an effective treatment for
neuroblastoma.
PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal
antibody 3F8 when given together with GM-CSF in treating young patients with high-risk,
refractory or relapsed neuroblastoma.
OBJECTIVES:
- Determine the maximum tolerated dose of monoclonal antibody 3F8 when administered with
sargramostim (GM-CSF) in young patients with high-risk, refractory or relapsed
neuroblastoma.
- Assess anti-neuroblastoma effects of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of monoclonal antibody 3F8.
Patients receive sargramostim (GM-CSF) subcutaneously once daily on days -5 to 11 and
monoclonal antibody 3F8 IV over 30 minutes on days 0-4 and 7-11. Treatment repeats every 4-6
weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody 3F8 until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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