Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma

Pts receive a total of 7 subcutaneous injections, at weeks 1, 2, 3, 8, 20, 32, \& 52. Minor schedule adjustments are permitted, as needed. Vaccines must occur a minimum of 6 days apart. Induction of antibody response against the target antigens will be assessed. A fixed dose of oral β-glucan (40 mg/kg/day) is started at week 6 or 7(to allow time for generation of antibodies), \& continued as approximately 2 weeks on, 2 weeks off, up to 1 cycle after the last vaccination. Neutrophils will be tested for glucan effects on cytotoxicity. Antineuroblastoma activity will be monitored using standard radiographic \& bone marrow studies, as well as RT-PCR for measurement of minimal residual disease in blood \& bone marrow. Phase II treatment schema for patients in 1st CR/VGPR or \>2nd CR/VGPR will be the same for the vaccine as in phase I except OPT-821 will be given at a fixed dose of 150 mcg/m2.

Phase II Patients will be randomized to starting oral β-glucan (40 mg/kg/day) in week 1 or in week 6.