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



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

For Condition: adult acute myeloid leukemia,Myelodysplastic Syndromes,atypical chronic myeloid leukemia,refractory chronic lymphocytic leukemia,myelodysplastic and myeloproliferative disease,Chronic Myelomonocytic Leukemia
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
VirginiaKlimek,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Stephen  Nimer 212-639-7871


Additional Information:
Study ID Numbers:
  CDR0000067491;  MSKCC-99057,NCI-G99-1661
Study Start Date: 
Record last reviewed: August 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004245

Other Myelodysplastic Syndromes Studies:
1. Low-Dose Chemotherapy and Radiation Therapy Before Allogeneic Stem Cell Transplantation in Treating Patients With Refractory Chronic Lymphocytic Leukemia

2. Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

3. Oblimersen in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

4. Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia

5. Comparison of Fludarabine Plus Total-body Irradiation With Combination Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

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