Leukemia Clinical Trial
Official title:
A Pilot Study of Nuclear Factor-kappa B (NFkB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia (AML)
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.
OBJECTIVES:
Primary
- Determine temporal changes in leukemic cell NF-kB activity when choline magnesium
trisalicylate is administered during induction chemotherapy in patients with newly
diagnosed acute myeloid leukemia.
- Determine toxicities of this regimen in these patients.
Secondary
- Determine patterns of leukemic cell gene expression in patients treated with this
regimen.
- Determine if NF-kB modulation results in enhanced apoptosis in patients treated with
this regimen.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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