Neuroblastoma Clinical Trial
Official title:
Monoclonal Antibody 3F8 and Oral Etoposide for the Treatment of Neuroblastoma
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
tumor killing substances to them without harming normal cells. Drugs used in chemotherapy
use different ways to stop tumor cells from dividing so they stop growing or die. Combining
monoclonal antibody therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus
etoposide in treating patients who have neuroblastoma.
OBJECTIVES:
- Determine the antitumor effects of monoclonal antibody 3F8, etoposide, and isotretinoin
using standard imaging methods and tumor marker studies in patients with high-risk
neuroblastoma.
- 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
unacceptable toxicity.
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
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