NCT00389506撤回不适用
A Pilot Study of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Hodgkin's Disease After Fludarabine and Cyclophosphamide
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Feasibility of using fludarabine phosphate and cyclophosphamide to decrease neutralizing antibodies
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. LMB-2 immunotoxin can find cancer cells and kill them without harming normal cells. Giving fludarabine and cyclophosphamide followed by LMB-2 immunotoxin may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide followed by LMB-2 immunotoxin works in treating patients with Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility of pretreatment with fludarabine phosphate and cyclophosphamide in preventing neutralization of antibodies in patients with CD25-positive Hodgkin's lymphoma.
Secondary
- Determine the response rate in patients treated with LMB-2 immunotoxin.
- Determine the response duration in patients receiving this treatment.
- Correlate serum levels of LMB-2 immunotoxin with toxicity and response in these patients.
- Assess the development of neutralizing antibodies and the effect of these antibodies on blood levels of LMB-2 immunotoxin and toxicity.
- Correlate soluble Tac-peptide levels with treatment response in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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:
- •Histopathologically confirmed CD25+ Hodgkin's lymphoma
- •At least 20% of the malignant cells positive by immunohistochemistry
- •Stage II-IV disease
- •Meets the following criteria:
- •Failed standard chemotherapy
- •Not eligible for curative salvage radiotherapy or chemotherapy
- •Not eligible for or refused bone marrow transplantation
- •Measurable disease
- •No patient whose serum neutralizes LMB-2 immunotoxin in tissue culture, due either to antitoxin or antimouse-IgG antibodies
- •No patient whose serum neutralizes > 75% of the activity of 1 µg/mL of LMB-2 immunotoxin
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Absolute neutrophil count ≥ 1,000/mm³
- •Platelet count ≥ 50,000/mm³
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •ALT and AST ≤ 2.5 times upper limit of normal
- •Albumin ≥ 3.0 g/dL
- •Bilirubin ≤ 2.2 mg/dL (< 5 mg/dL if Gilbert's syndrome is present)
- •Creatinine ≤ 1.4 mg/dL OR creatinine clearance ≥ 50 mL/min
- •No uncontrolled intercurrent illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness or social situations that would limit study compliance
- •No HIV or hepatitis C positivity
- •Hepatitis B surface antigen positivity allowed provided patient is receiving lamivudine
- •LVEF ≥ 45%
- •DLCO ≥ 50% of normal OR FEV_1 ≥ 60% of normal
- •No active second malignancy requiring treatment
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No systemic cytotoxic chemotherapy within the past 4 weeks
- •No systemic steroids (except stable doses of prednisone ≤ 20 mg/day) within the past 4 weeks
- •No monoclonal antibody therapy within the past 12 weeks
- •No prior LMB-2 immunotoxin
- •No concurrent warfarin
排除标准
- 未提供
结局指标
主要结局
Feasibility of using fludarabine phosphate and cyclophosphamide to decrease neutralizing antibodies
次要结局
- Response rate
- Development of neutralizing antibodies and its effect on blood level of LMB-2 immunotoxin and toxicity
- Correlation of soluble Tac-peptide with treatment response
- Correlation of serum levels of LMB-2 immunotoxin with toxicity and response
- Response duration
研究者
研究点 (1)
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