Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill lymphoma cells.
PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides or Sezary syndrome.
详细描述
OBJECTIVES:
- Determine the response rate in patients with mycosis fungoides or Sezary syndrome treated with interleukin-2 (IL-2).
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive interleukin-2 subcutaneously for 4 consecutive days a week for 6 consecutive weeks. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response or stable disease continue treatment for 2 courses past best response. Patients who demonstrate a persistent partial response continue treatment in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for survival.
研究设计
- 研究类型
- Interventional
- 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:
- •Histologically proven mycosis fungoides or Sezary syndrome
- •Any stage
- •Measurable disease with 1 or more indicator lesions
- •Evaluable disease for erythrodermic patients only
- •At least 2 weeks since prior therapy, if documented progressive disease (PD)
- •At least 4 weeks since prior therapy, if best response achieved without clear evidence of PD
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute granulocyte count at least 1,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2.2 mg/dL
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •No cardiac pacemaker
- •No clinically significant peripheral venous insufficiency
- •No other malignancy within the past 5 years except:
- •Treated squamous cell or basal cell skin cancer
- •Treated carcinoma in situ of the cervix
- •Surgically treated other cancer
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infection
- •HIV negative
- •No poorly controlled diabetes mellitus
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •No concurrent steroids
- •Radiotherapy:
- •See Disease Characteristics
- •No concurrent radiotherapy
- •Not specified
- •No other concurrent proven or investigational antineoplastic therapy
排除标准
- 未提供