Sodium Salicylate in Treating Patients With Advanced Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Chronic Lymphocytic Leukemia
NCT ID: NCT00004245
Last Updated: 2013-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
1999-08-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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sodium salicylate
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Principal Investigators
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Virginia Klimek, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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References
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Klimek VM, Dolezal EK, Smith L, Soff G, Nimer SD. Phase I trial of sodium salicylate in patients with myelodysplastic syndromes and acute myelogenous leukemia. Leuk Res. 2012 May;36(5):570-4. doi: 10.1016/j.leukres.2011.10.023. Epub 2011 Dec 9.
Other Identifiers
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MSKCC-99057
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1661
Identifier Type: -
Identifier Source: secondary_id
99-057
Identifier Type: -
Identifier Source: org_study_id
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