NCT00085150已完成1 期
Pediatric Phase I Trial of LMB-2 for Refractory CD25-Positive Leukemias and Lymphomas
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 5
研究概览
简要总结
RATIONALE: LMB-2 immunotoxin can locate cancer cells and kill them without harming normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of LMB-2 immunotoxin in treating young patients with relapsed or refractory leukemia or lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of LMB-2 immunotoxin in pediatric patients with CD-25 positive relapsed or refractory leukemia or lymphoma.
- Determine the toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug, including the terminal elimination serum half-life, area under the curve, volume of distribution, and relationship to disease burden, in these patients.
Secondary
- Evaluate the immonogenicity of this drug in these patients.
- Determine response in patients treated with this drug.
- Determine changes in lymphocyte subsets, immunoglobulin levels, serum cytokines, and soluble cytokine receptor levels in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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:
- •Non-Hodgkin's lymphoma, including the following subtypes:
- •Lymphoblastic lymphoma
- •Burkitt's lymphoma
- •Large cell lymphoma
- •Adult T-cell leukemia/lymphoma
- •Cutaneous T-cell lymphoma
- •Peripheral T-cell lymphoma
- •Hodgkin's disease
- •Acute myeloid leukemia
- •Chronic myelogenous leukemia
- •Acute lymphoblastic leukemia (ALL)
- •More than 5% blasts in the bone marrow (i.e., M2 marrow classification)
- •Acute hybrid leukemia, including the following subtypes:
- •Mixed lineage leukemia
- •Biphenotypic leukemia
- •Undifferentiated leukemia
- •CD25-positive (CD25+) disease, meeting 1 of the following criteria:
- •More than 15% of malignant cells are CD25+ by immunohistochemistry with anti-CD25 antibody
- •More than 30% of malignant cells from a site are CD25+ by fluorescence-activated cell sorting analysis
- •Measurable or evaluable disease
- •Relapsed or refractory disease after at least 1 standard chemotherapy regimen AND 1 salvage regimen
- •No available alternative curative therapies
- •Ineligible for or refused hematopoietic stem cell transplantation OR disease activity that prohibits the required time to identify a suitable stem cell donor
- •No CNS leukemia or lymphoma, as evidenced by any of the following criteria:
- •Cerebrospinal fluid (CSF) WBC > 5/µl AND confirmation of CSF blasts
- •Cranial neuropathies secondary to underlying malignancy
- •CNS lymphoma detected by radiological imaging
- •Prior CNS involvement with no current evidence of CNS malignancy allowed
- •No isolated testicular ALL
- •PATIENT CHARACTERISTICS:
- •6 months to 21 years
- •Performance status
- •ECOG 0-3 (≥ 12 years of age)
- •Lansky 40-100% (< 12 years of age)
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Pancytopenia due to disease allowed
- •For patients without bone marrow involvement:
- •Absolute neutrophil count > 1,000/mm^3
- •Platelet count > 50,000/mm^3 (transfusion independent)
- •Bilirubin ≤ 2.0 mg/dL
- •AST and ALT ≤ 5 times upper limit of normal
- •Hepatitis B surface antigen negative
- •Hepatitis C antibody negative
- •Creatinine clearance ≥ 60 mL/min OR
- •Creatinine, meeting the following age-related criteria:
- •≤ 0.8 mg/dL (≤ 5 years of age)
- 另有 38 项未显示
排除标准
- 未提供
研究者
研究点 (5)
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