3F8 Antibody Dose Escalation Plus Granulocyte-Macrophage Colony-Stimulating Factor in High-Risk Neuroblastoma: A Phase I Trial
- Determine the maximum tolerated dose of monoclonal antibody 3F8 when administered with
sargramostim (GM-CSF) in young patients with high-risk, refractory or relapsed
- 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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of monoclonal antibody 3F8
Brian H. Kushner, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|