HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study
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: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the safety and tolerability of multiple doses of monoclonal antibody HeFi-1 in patients with CD30+ anaplastic large cell lymphoma or Hodgkin's lymphoma.
- Determine the pharmacokinetics of this drug in this patient population.
- Evaluate the efficacy, in terms of correlating immunologic parameters and immunogenicity, of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks. Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response. Responding patients may continue treatment at monthly intervals for one year.
Cohorts of 3-4 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity.
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 CD30+ anaplastic large cell lymphoma (ALCL) or Hodgkin's lymphoma
- •At least 50% of malignant cells must react with HeFi-1
- •HIV positive or HIV negative
- •Measurable disease
- •No symptomatic CNS disease
- •Must have failed or be ineligible for standard chemotherapy regimen
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •More than 2 months
- •Hematopoietic:
- •Not specified
- •No significant hepatic disease
- •Bilirubin no greater than 2 mg/dL
- •No significant renal disease
- •Creatinine no greater than 3 mg/dL
- •Cardiovascular:
- •No significant cardiovascular disease
- •No significant pulmonary disease
- •No significant endocrine, rheumatologic, or allergic disease
- •No active clinical disease caused by cytomegalovirus (CMV), herpes simplex virus (HSV) I, HSV II, hepatitis B, or tuberculosis
- •Not pregnant
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior murine antibody therapy
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy to measurable disease
- •Not specified
- •At least 4 weeks since prior cytotoxic therapy to measurable disease
排除标准
- 未提供