NCT00002687已完成1 期
Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV]
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 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 cancer cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose and toxicity of interleukin-2 in patients with stage IIB-IV mycosis fungoides.
- Determine the response rate of patients treated with this regimen.
- Determine the immunologic response to this regimen in peripheral blood leukocytes and serum of these patients.
OUTLINE: This is a dose escalation study.
Patients receive interleukin-2 (IL-2) subcutaneously on days 1-5 during weeks 1-3 and on days 1-3 and 5 during week 4. Treatment repeats every 4 weeks for 4 courses.
Cohorts of 3-6 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity. Six additional patients receive IL-2 at 1 dose level preceding the MTD.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Clinically and histologically proven diagnosis of 1 of the following:
- •Mycosis fungoides (MF) meeting 1 of the following conditions:
- •Stage IIB disease that has failed psoralen ultraviolet A (PUVA) light therapy and topical chemotherapy (mechlorethamine and/or carmustine)
- •Stage III disease with generalized erythroderma
- •Stage IV disease with biopsy proven nodal or visceral involvement
- •Sezary syndrome
- •Stage III MF with a minimum of 20% Sezary cells (based on total WBC)
- •No clinically significant ascites or pleural effusion
- •Clinically significant pleural effusion defined as shortness of breath with oxygen saturation less than 90%
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 16 weeks
- •Hematopoietic:
- •See Disease Characteristics
- •WBC at least 3,500/mm^3
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 11.5 g/dL
- •Bilirubin less than 2.5 times normal
- •SGOT less than 2.5 times normal
- •Creatinine no greater than 2.0 mg/dL
- •No nephrotic syndrome
- •Cardiovascular:
- •No history of myocardial infarction or congestive heart failure
- •No symptomatic coronary artery disease
- •No clinically manifest hypotension
- •No severe hypertension
- •No arrhythmia on electrocardiogram
- •No contraindication to pressor agents
- •See Disease Characteristics
- •No dyspnea at rest or severe exertional dyspnea
- •Neurologic:
- •No significant CNS dysfunction, including any of the following:
- •Seizure disorder
- •Active cerebrovascular disease
- •Dementia or delirium
- •No autoimmune disease, including psoriasis
- •No uncontrolled peptic ulcer disease
- •No uncontrolled infection
- •No history of adverse reaction to interleukin-2
- •HIV and HTLV-I negative
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- 另有 13 项未显示
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Interleukin-2 in Treating Patients With Myelodysplastic SyndromeMyelodysplastic SyndromesLeukemiaMyelodysplastic/Myeloproliferative NeoplasmsNCT00002746University of Washington24
已完成
1 期
Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related CancerLymphomaNCT00058045Roswell Park Cancer Institute1
终止
2 期
Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary SyndromeLymphomaNCT00005788Northwestern University
终止
1 期
Inhaled Interleukin-2 in Treating Patients With Metastatic or Unresectable CancerUnspecified Adult Solid Tumor, Protocol SpecificNCT00003009University of Southern California16
已完成
1 期
Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous TreatmentKidney CancerLung CancerBladder CancerNCT00016237EMD Serono