Acute Myeloid Leukemia Clinical Trial
Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
Summary
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.
Full Description
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.
Eligibility 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
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There is 1 Location for this study
New York New York, 10021, United States
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