Phase I Study of Oral ß-Glucan and Intravenous Rituximab Among Children and Adolescents With Relapsed CD20-Positive Lymphoma or Leukemia, or Post-Transplant Lymphoproliferative Disease
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- maximum tolerated dose
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Beta-glucan may increase the effectiveness of rituximab by making cancer cells more sensitive to the monoclonal antibody.
PURPOSE: This phase I trial is studying the side effects and best dose of beta-glucan when given together with rituximab in treating young patients with relapsed or progressive lymphoma or leukemia or with lymphoproliferative disorder related to donor stem cell transplantation.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of beta-glucan when given in combination with rituximab in pediatric patients with relapsed or progressive CD20-positive lymphoma or leukemia or post-allogeneic stem cell transplant-related lymphoproliferative disorder.
- Determine the toxicity of this regimen, with special emphasis on the degree of B-cell depletion and immune suppression, in these patients.
- Determine the effects of beta-glucan on leukocyte-mediated cytotoxic effects in patients treated with this regimen.
Secondary
- Determine the antitumor effect of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed diagnosis of 1 of the following:
- •B-cell non-Hodgkin's lymphoma (NHL)
- •Hodgkin's lymphoma
- •Post-transplant lymphoproliferative disorder (PTLD)
- •Lymphoblastic leukemia
- •CD20-positive disease verified by immunophenotyping at original diagnosis, disease relapse, or disease progression
- •Refractory to conventional therapy, defined as 1 of the following:
- •Medically refractory HIV-associated NHL
- •Refractory or recurrent lymphoblastic leukemia
- •In > first relapse or progression of B-cell NHL or Hodgkin's lymphoma
- •Measurable (CT scan or MRI) or evaluable (marrow metastases or circulating lymphoblasts) disease within 4 weeks after completion of prior systemic (including systemic steroids) therapy
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 500/mm^3*
- •Platelet count > 10,000/mm^3* NOTE: *Excluding patients with PTLD or CD20-positive lymphoblastic leukemia
- •Hepatic toxicity ≤ grade 2
- •Creatinine clearance ≥ 60 mL/min
- •Renal toxicity ≤ grade 2
- •Cardiovascular
- •Cardiac toxicity ≤ grade 2
- •Pulmonary toxicity ≤ grade 2
- •Immunologic
- •Human anti-mouse antibody (HAMA) ≤ 1,000 units/mL
- •Human anti-chimeric antibody titer negative
- •No active, life-threatening infections except Epstein-Barr virus-associated lymphoproliferative disorder
- •No history of allergy to mouse proteins
- •No history of allergy to rituximab or other chimeric monoclonal antibodies
- •No history of allergy to beta-glucan or oats, barley, mushrooms, or yeast
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Grade 3 hearing deficit allowed
- •Gastrointestinal toxicity ≤ grade 2
- •Neurologic toxicity ≤ grade 2
- •No severe major organ toxicity
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •More than 4 weeks since prior rituximab
- •No prior mouse antibodies
- •No prior chimeric antibodies
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •See Disease Characteristics
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
Group II
Patients receive rituximab IV on days 1, 4, 8, 15, and 22 and oral beta-glucan once daily on days 8-28. Beginning on day 42, patients with responding disease may receive monthly rituximab prophylaxis.
干预措施: beta-glucan (Biological)
Group I
Patients receive rituximab IV on days 1, 8, 15, and 22 and oral beta-glucan once daily on days 1-28 (days 8-28 of course 1). Treatment repeats every 42 days for 4 courses.
干预措施: beta-glucan (Biological)
Group II
Patients receive rituximab IV on days 1, 4, 8, 15, and 22 and oral beta-glucan once daily on days 8-28. Beginning on day 42, patients with responding disease may receive monthly rituximab prophylaxis.
干预措施: rituximab (Biological)
Group I
Patients receive rituximab IV on days 1, 8, 15, and 22 and oral beta-glucan once daily on days 1-28 (days 8-28 of course 1). Treatment repeats every 42 days for 4 courses.
干预措施: rituximab (Biological)
结局指标
主要结局
maximum tolerated dose
时间窗: 2 years
次要结局
- safety(2 years)