Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia

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.

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:

Age:

• Over 18

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count at least 25,000/mm^3

Hepatic:

• 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

Renal:

• Creatinine no greater than 2.0 mg/dL OR
• Creatinine clearance greater than 60 mL/min

Other:

• 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

Surgery:

• Not specified