A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma and Hodgkin's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Phase II trial to study the effectiveness of interleukin-12 in treating patients with previously treated non-Hodgkin's lymphoma or Hodgkin's disease. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill lymphoma cells.
详细描述
PRIMARY OBJECTIVES:
I. Determine the response rate of interleukin-12 in previously treated patients with non-Hodgkin's lymphoma or Hodgkin's disease.
II. To determine the in vivo regulatory effect of interleukin-12 on Fas lingand (FasL) expression on patients' peripheral blood lymphocytes.
OUTLINE: Patients are stratified according to disease characteristics: low grade non-Hodgkin's lymphoma (follicular small cleaved, follicular mixed, small lymphocytic, and variants) versus intermediate grade non-Hodgkin's lymphoma (follicular large, diffuse large, diffuse mixed, immunoblastic, peripheral T-cell, and mantle cell) versus Hodgkin's disease.
Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously treated non-Hodgkin's lymphoma (all histologies except lymphoblastic and Burkitt's lymphoma) or Hodgkin's disease
- •Maximum of 4 previous treatment regimens
- •Measurable disease
- •No CNS involvement
- •Performance status - Zubrod 0-1
- •Performance status - Karnofsky 80-100%
- •At least 12 weeks
- •Platelet count at least 75,000/mm^3
- •Absolute neutrophil count greater than 1500/mm^3
- •Lymphocyte count greater than 500/mm^3
- •Hemoglobin at least 8.0 g/dL
- •Bilirubin less than 1.5 mg/dL
- •SGOT/SGPT less than 2 times normal
- •Creatinine no greater than 1.6 mg/dL
- •Creatinine clearance at least 60 mL/min
- •No severe cardiovascular disease including active ischemic heart disease, congestive heart failure, or major arrhythmias
- •No severe pulmonary disease including dyspnea with moderate to severe exertion
- •HIV negative
- •No active infection
- •Not pregnant or nursing
- •Fertile patients must use adequate contraception
- •No clinically significant autoimmune disease (e.g. rheumatoid arthritis)
- •No clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer
- •No prior allogeneic bone marrow or stem cell transplant
- •At least 3 weeks since prior biologic therapy for lymphoma
- •At least 3 weeks since prior chemotherapy for lymphoma
- •No concurrent steroid therapy
- •At least 3 weeks since prior endocrine therapy for lymphoma
- •At least 3 weeks since prior radiotherapy for lymphoma
- •At least 2 weeks since prior surgery
排除标准
- 未提供
研究组 & 干预措施
Treatment (interleukin-12)
Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Treatment (interleukin-12)
Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: recombinant interleukin-12 (Biological)
结局指标
主要结局
Response rate
时间窗: Up to 5 years
Simon's two-stage model will be used.
次要结局
- Toxicity as assessed by CTC version 2.0(Up to 5 years after completion of study treatment)