Phase I Study of Oral Beta-Glucan and Intravenous Anti-GD2 Monoclonal Antibody 3F8 Among Patients With Metastatic Neuroblastoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •Not specified
- •Creatinine clearance greater than 60 mL/min
- •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
- •Not specified
- •No other concurrent supplemental beta-glucan either as food (e.g., bran cereals) or as complementary medicine
排除标准
- 未提供