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.

Condition	Treatment or Intervention	Phase
adult acute myeloid leukemia atypical chronic myeloid leukemia childhood acute myeloid leukemia and other myeloid malignancies Chronic Lymphocytic Leukemia Chronic Myelomonocytic Leukemia myelodysplastic and myeloproliferative disease	Drug: sodium salicylate  Procedure: chemotherapy	Phase I

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Virginia Klimek, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000067491; MSKCC-99057; NCI-G99-1661; NCT00004245
Record last reviewed:  January 2005
Last Updated:  January 10, 2005
Record first received:  January 28, 2000
ClinicalTrials.gov Identifier:  NCT00004245
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08