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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma

Conditions
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Neuroblastoma

Intervention / Treatment
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* Biological: beta-glucan
* Biological: monoclonal antibody 3F8


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: beta-glucan|nan|
|Biological: monoclonal antibody 3F8|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disseminated neuroblastoma, recurrent neuroblastoma