Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
A PHASE I TRIAL OF SUBCUTANEOUS, OUTPATIENT INTERLEUKIN-2 FOR PATIENTS WITH MYELODYSPLASTIC SYNDROME (MDS)
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 with myelodysplastic syndrome.
研究概览
详细说明
OBJECTIVES:
- Determine the safety, tolerance, and maximum tolerated dose of subcutaneous interleukin-2 (aldesleukin; IL-2) in patients with myelodysplastic syndrome (MDS).
- Evaluate the hematologic effects of subcutaneous IL-2 in MDS.
OUTLINE: IL-2 will be administered in cycles of twice daily subcutaneous injections 7 days a week for 4 consecutive weeks. After each cycle the patient will be evaluated for response. The patient could continue IL-2 therapy for up to 12 cycles. There are 4 dose levels of IL-2. At each dose level 3 patients will be accrued sequentially.
Treatment with IL-2 should be continued until grade III toxicity or any side effects requiring hospitalization occurs. After the patient returns to baseline pretherapy values or grade I toxicity, the subject will resume IL-2 at 50% of the initial dose. If the patient again goes into grade III toxicity or is in need of hospitalization, IL-2 will be discontinued.
PROJECTED ACCRUAL: Between 12-24 patients will be accrued.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Washington
-
Seattle、Washington、美国、98195-6043
- University of Washington Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
- Histologically confirmed myelodysplastic syndrome: Refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML)
- No patients with refractory anemia with excess blasts in transformation (RAEB-t)
PATIENT CHARACTERISTICS:
Age:
- 15 and over
Performance status:
- Karnofsky 70-100
Hematopoietic:
- Platelet count greater than 20,000
Hepatic:
- Bilirubin less than 1.6 mg/dL
- SGOT less than 150 U/L
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No symptoms of coronary artery disease, congestive heart failure, edema, clinically manifest hypotension, presence of cardiac arrhythmias on EKG, or severe hypertension
Pulmonary:
- No significant pleural effusion, dyspnea at rest or severe exertional dyspnea
Other:
- No patients with nephrotic syndrome
- No uncontrolled infections or active peptic ulcer disease
- No serious intercurrent medical illness
- Not pregnant or nursing
- Adequate contraception required of all patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunosuppressive therapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- At least 2 weeks since corticosteroid therapy
- At least 4 weeks since other endocrine therapy
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
合作者和调查者
调查人员
- 学习椅:John A. Thompson, MD、Seattle Cancer Care Alliance
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 10469 (DAIDS ES Registry Number)
- UW-26-245-B
- NCI-V96-0848
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
阿地白介素的临床试验
-
University Health Network, Toronto完全的
-
Groupe Francophone des MyelodysplasiesEpiCept Corporation撤销
-
University Health Network, Toronto主动,不招人
-
University Health Network, TorontoMerck Sharp & Dohme LLC完全的