A Phase I Trial Of Rituximab And Interleukin-2
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- MTD defined as the dose preceding that at which at least 2 of 6 patients experience DLT using NCI CTC version 2.0
研究概览
简要总结
Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells. Phase I trial to study the effectiveness of rituximab plus interleukin-2 in treating patients who have hematologic cancer.
详细描述
OBJECTIVES: Determine the dose-limiting toxicity of rituximab followed by low-dose and intermediate-dose pulse interleukin-2 (IL-2) in patients with CD20-positive B-cell lymphoid malignancy.
Determine the maximum tolerated dose of intermediate-dose pulse IL-2 in this patient population.
Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study of intermediate-dose pulse aldesleukin.
Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin subcutaneously (SC) on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84. Cohorts of 3-6 patients receive escalating doses of intermediate-dose pulse aldesleukin until the maximum tolerated dose (MTD) is reached. 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
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or immunophenotypically proven CD20-positive B-cell lymphoproliferative disorder
- •Recurrent or progressive low-grade B-cell lymphoma with at least one prior chemotherapy regimen (may have included monoclonal antibody)
- •Relapsed intermediate-grade or high-grade B-cell lymphoma or B-lineage acute lymphoblastic leukemia and patient not a candidate for, refused, or failed prior hematopoietic stem cell transplantation
- •No chronic lymphocytic leukemia or lymphoma with more than 5,000/mm3circulating lymphoma cells
- •Measurable or evaluable disease
- •Must have failed standard curative therapy
- •No CNS or leptomeningeal metastasis
- •Performance status - Karnofsky 70-100%
- •Performance status - ECOG 0-1
- •At least 4 months
- •Absolute neutrophil count at least 1,000/mm^3
- •Hemoglobin at least 10 g/dL (transfusion allowed)
- •Platelet count at least 50,000/mm^3
- •AST no greater than upper limit of normal (ULN)
- •Bilirubin no greater than 1.5 times ULN
- •Hepatitis B surface antigen negative
- •Creatinine no greater than ULN
- •No prior unstable coronary artery disease
- •No New York Heart Association class III or IV congestive heart failure
- •DLCO and FEV1 at least 50% of predicted
- •HIV negative
- •No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No infection requiring IV antibiotic therapy within the past 4 weeks
- •No other major illness that would preclude study
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •See Disease Characteristics
- •Prior antibody therapy allowed
- •Prior interleukin-2 or interferon alfa allowed
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy
- •At least 4 weeks since prior systemic corticosteroids
- •At least 4 weeks since prior radiotherapy
- •At least 4 weeks since prior surgery
排除标准
- 未提供
结局指标
主要结局
MTD defined as the dose preceding that at which at least 2 of 6 patients experience DLT using NCI CTC version 2.0
时间窗: 2 weeks
Data collected will be descriptive and provide limited estimates of variability given the small sample sizes at each dose level.
次要结局
未报告次要终点