Phase II Study of Anti-GD2 3F8 Antibody and Biologic Response Modifiers for High-risk Neuroblastoma
- Determine the efficacy of beta-glucan, isotretinoin, and sargramostim (GM-CSF) in
enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk
- Determine the antitumor activity of this regimen, in terms of assessing disease status
in the bone marrow by real-time quantitative reverse transcription polymerase chain
reaction, in these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is an open-label study. Patients are stratified according to refractory
disease (primary refractory [never had disease progression or disease recurrence] vs
secondary refractory [recurrent disease that did not respond completely to reinduction
- Courses 1 and 2: Patients receive sargramostim (GM-CSF) subcutaneously once daily on
days -5 to 11. Patients also receive oral beta-glucan once daily on days -2 to 11 and
monoclonal antibody (MOAB) 3F8 IV over 30-90 minutes on days 0-4 and 7-11.
- Courses 3 and 4: Patients receive GM-CSF, beta-glucan, and MOAB 3F8 as above. Patients
also receive oral isotretinoin twice daily on days -2 to 11.
Treatment repeats every 2-4 weeks for 4 courses in the absence of disease progression or
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 27-74 patients (10-33 for stratum 1 and 17-41 for stratum 2)
will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Disease response as assessed by PT-PC at the end of 4 courses
Nai-Kong V. Cheung, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|