Gene Expression During Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Choline Magnesium Trisalicylate
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|ClinicalTrials.gov Identifier: NCT00156299|
Recruitment Status : Terminated (Replaced by another study)
First Posted : September 12, 2005
Last Update Posted : November 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: choline magnesium trisalicylate Drug: Dexamethasone||Phase 1|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Nuclear Factor-kappa B (NFkB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia (AML)|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
Experimental: Dexamethasone plus Choline Magnesium Trisalicylate
Dexamethasone plus Choline Magnesium Trisalicylate
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.
Experimental: Choline Magnesium Trisalicylate
Choline Magnesium Trisalicylate
Drug: choline magnesium trisalicylate
1500mg orally every 8 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156299
|United States, New Jersey|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Roger Strair, MD, PhD||Rutgers Cancer Institute of New Jersey|