Beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma
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.
Biological: monoclonal antibody 3F8
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma|
|Study Start Date:||November 2001|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00037011
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Nai-Kong V. Cheung, MD, PhD||Memorial Sloan Kettering Cancer Center|