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

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia

Conditions
-----------------
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

Intervention / Treatment
-----------------
* Drug: sodium salicylate


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sodium salicylate|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic myelomonocytic leukemia, recurrent adult acute myeloid leukemia, refractory chronic lymphocytic leukemia, untreated adult acute myeloid leukemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, previously treated myelodysplastic syndromes, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)