A Phase 1 interventional study of choline magnesium trisalicylate and Dexamethasone in Leukemia, sponsored by Rutgers, The State University of New Jersey. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-19.
Sponsored by Rutgers, The State University of New Jersey · Phase 1, Interventional, and Treatment
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
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 15 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed acute myeloid leukemia
PATIENT CHARACTERISTICS:
No upper or lower gastrointestinal (GI) related hemorrhage within the past 6 months as determined by endoscopy
PRIOR CONCURRENT THERAPY:
Dexamethasone plus Choline Magnesium Trisalicylate
Drug: choline magnesium trisalicylate · Drug: Dexamethasone
Choline Magnesium Trisalicylate
Drug: choline magnesium trisalicylate
1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48.
10mg orally every 6 hours beginning at hour 0 and continuing until hour 48.
Temporal changes in leukemic cell NF-kB activity
Time frame: 5 years
Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate
Time frame: 5 years
Apoptosis related to NF-kB modulation
Time frame: 5 years
This study is terminated, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey