beta-glucan and monoclonal antibody in treating patients with metastatic neuroblastoma

Conditions: Neuroblastoma

Summary: 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.

Eligibility criteria:
disease characteristics: * histologically confirmed high-risk stage 4 metastatic neuroblastoma * may be confirmed by bone marrow involvement and elevated urinary catecholamines * progressive or persistent disease after intensive conventional chemotherapy that included induction with n6, n7, n8, or cog protocol with or without bone marrow or stem cell transplantation * poor long-term prognosis as defined by any of the following: * n-myc amplification in tumor cells * diploid chromosomal content plus 1p loss of heterozygosity in tumor cells * distant skeletal metastases * unresectable primary tumor infiltrating across the midline * more than 10% tumor cells in bone marrow * measurable or evaluable disease documented at least 4 weeks after completion of prior systemic therapy patient characteristics: age: * under 50 performance status: * not specified life expectancy: * see disease characteristics hematopoietic: * platelet count greater than 25,000/mm\^3 * absolute neutrophil count greater than 500/mm\^3 hepatic: * not specified renal: * creatinine clearance greater than 60 ml/min other: * no severe major organ toxicity * no active life-threatening infections * no prior allergy to mouse proteins * no prior allergy to beta-glucan, oats, barley, mushrooms, or yeast * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * see disease characteristics * no prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 elisa units/ml chemotherapy: * see disease characteristics endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * no other concurrent supplemental beta-glucan either as food (e.g., bran cereals) or as complementary medicine

Keywords: disseminated neuroblastoma recurrent neuroblastoma