Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00004245


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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