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Brief Title: Beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma
Official Title: Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma
Study ID: NCT00037011
Brief 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.
Detailed Description: 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.
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Name: Nai-Kong V. Cheung, MD, PhD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR