Monoclonal Antibody 3F8 and Oral Etoposide for the Treatment of Neuroblastoma
- Determine the antitumor effects of monoclonal antibody 3F8, etoposide, and isotretinoin
using standard imaging methods and tumor marker studies in patients with high-risk
- Assess progression-free survival in these patients after this treatment.
- Assess the effects of oral etoposide on human anti-mouse antibody and anti-idiotype
response in these patients.
OUTLINE: Patients are stratified according to disease status (evaluable but not measurable
vs second or subsequent remission with no measurable or evaluable disease).
Patients receive monoclonal antibody 3F8 (MOAB 3F8) IV over 1.5 hours once daily on days
1-10 and oral etoposide once daily on days 29-49. Treatment repeats every 8 weeks for 4
courses in the absence of disease progression, human anti-mouse antibody (HAMA) response, or
If HAMA fails to develop after completion of 4 courses of MOAB 3F8, patients continue
treatment with MOAB 3F8 on days 1-5 every 8 weeks until HAMA reaches greater than 1,000 U/mL
or until month 24, whichever occurs first.
Beginning after completion of 4 courses of etoposide and MOAB 3F8 or if HAMA develops,
patients receive oral isotretinoin twice daily for 14 days followed by at least a 14-day
rest. Treatment repeats for a total of 6 courses.
PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study
within 5 years.
Masking: Open Label, Primary Purpose: Treatment
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|