A Phase I Study of Salicylate for Adult Patients With Advanced Myelodysplastic Disorders or Acute Myelogenous Leukemia
sodium salicylate
Anemia+26
+ Anemia, Refractory
+ Bone Marrow Diseases
Treatment Study
Summary
Study start date: August 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Memorial Sloan-Kettering Cancer Center
New York, United StatesOpen Memorial Sloan-Kettering Cancer Center in Google Maps