Neuroblastoma Clinical Trial
Official title:
Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma
RATIONALE: Biological therapies such as beta-glucan use different ways to stimulate the
immune system and stop cancer cells from growing. Monoclonal antibodies can locate tumor
cells and either kill them or deliver tumor-killing substances to them without harming
normal cells. Combining beta-glucan and monoclonal antibody may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining beta-glucan and monoclonal
antibody in treating patients who have metastatic neuroblastoma.
OBJECTIVES:
- Determine the maximum tolerated dose of beta-glucan and monoclonal antibody 3F8 in
patients with metastatic neuroblastoma.
- Determine the toxicity of this regimen in these patients.
- Assess the biological effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oral beta-glucan and monoclonal antibody 3F8 (MOAB 3F8) IV within 1.5 hours
on days 1-5 and 8-12. Treatment repeats every 28 days for up to 4 courses in the absence of
disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of beta-glucan and MOAB 3F8 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which
at least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 6 months, every 2 months for 6 months, and then every 3-6
months for 2 years.
PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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