NCT00024115撤回1 期
Phase I Study of Recombinant BL22 Immunotoxin in Patients With CD22-Positive B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
研究概览
简要总结
RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of the BL22 immunotoxin in treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
- Determine the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with CD22-positive B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
- Determine the pharmacokinetics, including the terminal elimination serum half-life area under the curve and volume of distribution, of recombinant BL22 immunotoxin in these patients.
- Determine the immunogenicity of recombinant BL22 immunotoxin in these patients.
- Determine the effect of recombinant BL22 immunotoxin on various components of the circulating cellular immune system in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Patients may be retreated at least every 20 days for up to 25 courses in the absence of disease progression and sufficient neutralizing antibodies.
Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed chronic lymphocytic leukemia or prolymphocytic leukemia:
- •Failed prior standard chemotherapy and treatment is medically indicated as evidenced by the following:
- •Progressive disease-related symptoms
- •Progressive cytopenias due to marrow involvement
- •Progressive or painful splenomegaly or adenopathy
- •Rapidly increasing lymphocytosis
- •Autoimmune hemolytic anemia or thrombocytopenia
- •Increased frequency of infections OR
- •Confirmed CD22+ B-cell indolent non-Hodgkin's lymphoma
- •Stages II-IV that have failed at least 1 prior standard therapy and treatment is medically indicated
- •No patients whose serum neutralizes BL22 or PE38 in tissue culture, due to antitoxin or antimouse-IgG antibodies
- •No central nervous system disease requiring treatment
- •If the patient is non-leukemic, the absolute neutrophil count must be greater than 1,000/mm3 and the platelet count greater than 40,000/mm3
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 6 months
- •Hematopoietic:
- •See Disease Characteristics
- •ALT and AST less than 5 times upper limit of normal
- •Adequate renal function
- •Adequate pulmonary function
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior bone marrow transplantation allowed
- •At least 3 weeks since prior interferon for malignancy
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior cytotoxic chemotherapy for malignancy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 3 weeks since prior radiotherapy for malignancy
- •Not specified
- •At least 3 weeks since prior retinoids
- •At least 3 weeks since prior systemic therapy for cancer
排除标准
- 未提供
研究者
研究点 (1)
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