NCT00156299

Gene Expression During Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Choline Magnesium Trisalicylate

A Pilot Study of Nuclear Factor-kappa B (NFkB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia (AML)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	choline magnesium trisalicylate	1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48.
DRUG	Dexamethasone	10mg orally every 6 hours beginning at hour 0 and continuing until hour 48.

Timeline

• Start date: 2003-03-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2005-09-12
• Last updated: 2013-11-19

Locations

1 site across 1 country: United States