NCT00053001已完成2 期
A Phase II Study on the Effectiveness of Thalomid (Thalidomide) Combined With Procrit (Erythropoietin) for the Treatment of Anemia in Patients With Low and Intermediate Risk-1 (IPSS Score Less Than or Equal to 1.5) Myelodysplastic Syndromes
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 4
- 主要终点
- Clinical response
研究概览
简要总结
RATIONALE: Thalidomide may stop or slow the growth of cancer cells. Epoetin alfa may stimulate red blood cell production. Combining thalidomide with epoetin alfa may improve anemia, decrease the need for blood transfusions, and improve the quality of life in patients with myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with epoetin alfa in treating anemia in patients who have myelodysplastic syndrome.
详细描述
OBJECTIVES:
- Determine whether the combination of epoetin alfa and thalidomide improves the anemia and/or decreases the need for red cell transfusion in patients with low- or intermediate-risk myelodysplastic syndromes.
- Determine whether this regimen improves the bone marrow morphology and cytogenetics, alters the natural history of the disease, and reduces the frequency of leukemic transformation in these patients.
- Evaluate whether this regimen improves pathophysiologic parameters (e.g., apoptosis, tumor necrosis factor-alpha concentration, microvessel density, vascular endothelial growth factor, and cytotoxic T lymphocytes) in the bone marrow of these patients.
- Determine the safety of this regimen in these patients.
OUTLINE: Patients receive epoetin alfa subcutaneously (SC) once weekly for 8 weeks. After 8 weeks, patients unresponsive to epoetin alfa alone receive oral thalidomide once daily in addition to epoetin alfa SC once weekly for a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 2 years..
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of myelodysplastic syndromes
- •Newly diagnosed OR
- •Prior treatment was unsuccessful, including treatment with chemotherapy
- •International prognostic scoring system score no greater than 1.5
- •Hemoglobin no greater than 10 g/dL (untransfused) AND/OR
- •Received at least 3 units of packed red blood cells for symptomatic anemia within the past 6 weeks
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •At least 6 months
- •Hematopoietic
- •See Disease Characteristics
- •No prior bleeding disorder
- •Bilirubin less than 2 mg/dL
- •ALT/AST less than 2 times upper limit of normal
- •Creatinine less than 1.5 mg/dL
- •Cardiovascular
- •No prior clinically significant heart disease
- •No uncontrolled hypertension
- •No recent thromboembolic disease (e.g., deep vein thrombosis)
- •Prior thromboembolic events allowed provided event occurred at least 6 weeks prior to study and patient is on anticoagulants and is clinically stable
- •No unstable pulmonary disease
- •No recent pulmonary embolism
- •No active pulmonary infection
- •No pre-existing peripheral neuropathy greater than grade 2
- •No sustained neurologic deficit
- •No epilepsy
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 effective methods (including 1 highly effective method) of contraception for at least 4 weeks before, during, and for at least 4 weeks after study completion
- •No active infection
- •No concurrent illness that would obscure toxicity or dangerously alter drug metabolism
- •No other serious concurrent medical illness
- •No uncontrolled diabetes mellitus
- •No other malignant disease (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off therapy for that disease for more than 1 year
- •No known hypersensitivity to mammalian cell-derived products or human albumin
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •At least 4-6 weeks since prior therapy
排除标准
- 未提供
结局指标
主要结局
Clinical response
次要结局
未报告次要终点
研究者
研究点 (4)
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