NCT00021983已完成1 期
Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas
适应症
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: An immunotoxin can locate cancer cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia.
PURPOSE: Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients who have refractory or recurrent hairy cell leukemia.
详细描述
OBJECTIVES:
- Assess the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with refractory or recurrent CD22+ hairy cell leukemia.
- Define the pharmacokinetics of this drug, including the terminal elimination serum half-life area under the curve and volume of distribution, in these patients.
- Evaluate the immunogenicity of this drug in these patients.
- Determine the effect of this drug 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. Treatment repeats at least every 42 days for up to 4 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 at which no more than 1 of 6 patients experiences 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 refractory or recurrent hairy cell leukemia
- •Relapsed after less than 2 years of complete remission after purine analog therapy
- •Must have at least one of the following indications for therapy:
- •Progressive or massive splenomegaly
- •Cytopenia defined by the following:
- •Absolute neutrophil count less than 1,000/mm^3 OR
- •Platelet count less than 100,000/mm^3 OR
- •Hemoglobin less than 12 g/dL
- •More than 20,000 hairy cells/mm^3
- •Symptomatic adenopathy
- •Constitutional symptoms including tumor-related fever or bone pain
- •Evidence of CD22 positivity by 1 of the following:
- •More than 15% of malignant cells from a site must react with anti-CD22 by immunohistochemistry
- •More than 30% of malignant cells from a site CD22+ by fluorescent-activated cell sorter
- •More than 400 CD22 sites/cell (average) on malignant cells as assessed by radiolabeled anti-CD22 binding
- •No CNS disease requiring treatment
- •No patients whose serum neutralizes BL22 immunotoxin in tissue culture, due to either antitoxin or antimouse-IgG antibodies
- •No patients whose serum neutralizes more than 75% of the activity of 1 microgram/mL of BL22 immunotoxin
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 6 months
- •Hematopoietic:
- •See Disease Characteristics
- •Pancytopenia due to disease allowed
- •ALT and AST less than 2.5 times upper limit of normal (ULN)
- •Bilirubin less than 1.5 times ULN
- •Creatinine no greater than 2.0 mg/dL
- •FEV1 at least 60% of predicted
- •DLCO at least 55% of predicted
- •HIV negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior bone marrow transplantation allowed
- •At least 3 weeks since prior interferon for the malignancy
- •More than 3 months since prior monoclonal antibody therapy (e.g., rituximab)
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior cytotoxic chemotherapy for the malignancy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 3 weeks since prior whole body electron beam radiotherapy for the malignancy
- •Radiotherapy within the past 3 weeks allowed provided less than 10% of total bone marrow was treated and patient has measurable disease outside the radiation port
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排除标准
- 未提供
研究者
研究点 (1)
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