NCT00055783已完成2 期
A Phase II Study of Hu1D10 in Recurrent Hodgkin's Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have progressive or recurrent Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the response rate of patients with recurrent Hodgkin's lymphoma treated with monoclonal antibody Hu1D10.
- Determine the duration of response and progression-free survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive monoclonal antibody Hu1D10 IV over 2 hours. Treatment repeats weekly for a total of 4 doses in the absence of disease progression or unacceptable toxicity.
Patients are followed at weeks 5 and 8 and then every 3 months thereafter.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed Hodgkin's lymphoma
- •Progressive or recurrent disease after standard initial therapy
- •At least 1 unidimensionally measurable lesion (at least 15 mm by conventional techniques)
- •Patients in first relapse must be ineligible or unwilling to receive high-dose therapy and stem cell transplantation
- •Evidence of Hu1D10 localization to Reed Sternberg cells by immunohistochemistry
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •More than 6 months
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •AST and ALT no greater than 2.5 times upper limit of normal
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •HIV negative
- •No known human anti-human antibody
- •No prior allergic reaction to compounds of similar chemical or biological composition to monoclonal antibody Hu1D10
- •No ongoing or active infection
- •No other uncontrolled concurrent illness
- •No psychiatric illness or social situation that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Disease Characteristics
- •See Chemotherapy
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •Prior second-line (or greater) high-dose therapy and stem cell transplantation allowed
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •At least 4 weeks since prior radiotherapy and recovered
- •Not specified
- •No other concurrent investigational agents
- •No other concurrent anticancer agents or therapies
排除标准
- 未提供
研究者
研究点 (2)
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