A Pilot Study of Nuclear Factor-kappa B (NFkB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia (AML)
Overview
- Phase
- Phase 1
- Intervention
- choline magnesium trisalicylate
- Conditions
- Leukemia
- Sponsor
- Rutgers, The State University of New Jersey
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Temporal changes in leukemic cell NF-kB activity
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dexamethasone plus Choline Magnesium Trisalicylate
Dexamethasone plus Choline Magnesium Trisalicylate
Intervention: choline magnesium trisalicylate
Dexamethasone plus Choline Magnesium Trisalicylate
Dexamethasone plus Choline Magnesium Trisalicylate
Intervention: Dexamethasone
Choline Magnesium Trisalicylate
Choline Magnesium Trisalicylate
Intervention: choline magnesium trisalicylate
Outcomes
Primary Outcomes
Temporal changes in leukemic cell NF-kB activity
Time Frame: 5 years
Secondary Outcomes
- Apoptosis related to NF-kB modulation(5 years)
- Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate(5 years)