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

This study has been terminated.
(Replaced by another study)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00156299
First received: September 8, 2005
Last updated: November 18, 2013
Last verified: November 2013

September 8, 2005
November 18, 2013
March 2003
July 2008   (final data collection date for primary outcome measure)
Temporal changes in leukemic cell NF-kB activity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
To determine various effects of NFkB inhibitors
Complete list of historical versions of study NCT00156299 on ClinicalTrials.gov Archive Site
  • Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Apoptosis related to NF-kB modulation [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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)

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia
  • 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: Dexamethasone plus Choline Magnesium Trisalicylate
    Dexamethasone plus Choline Magnesium Trisalicylate
    Interventions:
    • Drug: choline magnesium trisalicylate
    • Drug: Dexamethasone
  • Experimental: Choline Magnesium Trisalicylate
    Choline Magnesium Trisalicylate
    Intervention: Drug: choline magnesium trisalicylate
Strair RK, Gharibo M, Schaar D, Rubin A, Harrison J, Aisner J, Lin HC, Lin Y, Goodell L, Anand M, Balsara B, Dudek L, Rabson A, Medina DJ. Nuclear factor-kappaB modulation in patients undergoing induction chemotherapy for acute myelogenous leukemia. Clin Cancer Res. 2008 Nov 15;14(22):7564-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
July 2008
July 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed acute myeloid leukemia

    • Newly diagnosed disease
  • Presence of cytogenetic abnormalities must be determined by standard cytogenetics with or without FISH studies
  • Leukemic blast count > 5,000/mm³ of peripheral blood
  • No acute promyelocytic leukemia (M3)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-3
  • Bilirubin < 2.0 times upper limit of normal (ULN)
  • AST < 3.0 times ULN
  • Creatinine < 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled psychiatric illness that, in the opinion of the principal investigator, would preclude study compliance
  • No other concurrent medical condition that would preclude study compliance
  • No allergies to any investigational drugs and/or chemotherapeutic agents
  • No upper or lower gastrointestinal (GI) related hemorrhage within the past 6 months as determined by endoscopy

    • No clinical diagnosis of GI bleeding requiring blood transfusions

PRIOR CONCURRENT THERAPY:

  • No prior induction therapy
  • No prior chemotherapy for acute leukemia
  • No concurrent medications that would preclude study compliance
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00156299
CDR0000540303, P30CA072720, 020201
No
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Principal Investigator: Roger Strair, MD, PhD Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP