A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia
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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of sodium salicylate in treating patients who have advanced myelodysplastic syndrome , acute myelogenous leukemia or chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
- Evaluate the safety, toxicity, and pharmacokinetics of sodium salicylate in patients with advanced myelodysplastic syndrome; newly diagnosed, relapsed, or refractory acute myelogenous leukemia; or relapsed or refractory chronic lymphocytic leukemia.
- Define biologic characteristics that influence the likelihood of a clinical response to this drug in this patient population.
OUTLINE: Patients receive oral sodium salicylate twice a day. Intrapatient dose escalation or de-escalation is permitted. Treatment continues for up to 6 weeks in the absence of unacceptable toxicity or disease progression. Responding patients may continue to receive sodium salicylate beyond the 6-week period.
Patients with acute myelogenous leukemia are followed until the end of therapy. Patients with myelodysplastic syndrome are followed until death or progression to leukemia.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 1 year.
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:
- •Relapsed or refractory acute myelogenous leukemia OR
- •Elderly patients with newly diagnosed acute myelogenous leukemia not eligible for standard therapy OR
- •"High-risk" myelodysplastic syndrome, including:
- •Refractory anemia with excess blasts
- •Refractory anemia with excess blasts in transformation
- •Chronic myelomonocytic leukemia OR
- •Relapsed or refractory chronic lymphocytic leukemia
- •Not eligible for transplant protocols at MSKCC or refuses transplant
- •Not eligible for a higher priority protocol (e.g., bone marrow transplantation)
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count at least 25,000/mm^3
- •Bilirubin no greater than 2.0 mg/dL
- •Transaminase levels less than 3 times upper limit of normal
- •PT no greater than 14 seconds
- •PTT no greater than 34.6 seconds
- •Creatinine no greater than 2.0 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Not pregnant or nursing
- •No history of abnormal bleeding or unexplained bleeding disorders
- •No history of peptic ulcer disease
- •No salicylate allergy
- •No other concurrent active malignancy
- •No other concurrent illness that would preclude study assessment to a significant degree
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
排除标准
- 未提供