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About
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in cancer cells. It may also help doctors understand how cancer cells respond to treatment with choline magnesium trisalicylate.
PURPOSE: This pilot clinical trial is studying gene expression in cancer cells during chemotherapy and the safety of choline magnesium trisalicylate in treating patients with newly diagnosed acute myeloid leukemia.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, pilot study.
Patients receive oral choline magnesium trisalicylate every 8 hours for 48 hours or dexamethasone every 6 hours for 48 hours plus choline magnesium trisalicylate every 8 hours for 48 hours during induction chemotherapy as determined by the primary physician.
Blood is collected at baseline, 24 hours, and 48 hours to assess for changes in NF-kB expression, apoptosis, and gene expression in leukemic cells.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed acute myeloid leukemia
Presence of cytogenetic abnormalities must be determined by standard cytogenetics with or without FISH studies
Leukemic blast count > 5,000/mm³ of peripheral blood
No acute promyelocytic leukemia (M3)
PATIENT CHARACTERISTICS:
ECOG performance status 0-3
Bilirubin < 2.0 times upper limit of normal (ULN)
AST < 3.0 times ULN
Creatinine < 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled psychiatric illness that, in the opinion of the principal investigator, would preclude study compliance
No other concurrent medical condition that would preclude study compliance
No allergies to any investigational drugs and/or chemotherapeutic agents
No upper or lower gastrointestinal (GI) related hemorrhage within the past 6 months as determined by endoscopy
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
Masking
15 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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