Beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma

Memorial Sloan Kettering Cancer Center

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Neuroblastoma

Interventions

beta-glucanBIOLOGICAL

monoclonal antibody 3F8BIOLOGICAL

Eligibility

Sex: ALLMax age: 49 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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