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
  Purpose

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 Intervention Phase
Leukemia
Drug: choline magnesium trisalicylate
Drug: Dexamethasone
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Nuclear Factor-kappa B (NFkB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia (AML)

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Temporal changes in leukemic cell NF-kB activity [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: March 2003
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156299

Locations
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Roger Strair, MD, PhD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
Publications:
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00156299     History of Changes
Other Study ID Numbers: CDR0000540303, P30CA072720, 020201
Study First Received: September 8, 2005
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myelomonocytic leukemia (M4)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
untreated adult acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Choline
Dexamethasone
Dexamethasone acetate
Choline magnesium trisalicylate
Salicylates
Dexamethasone 21-phosphate
BB 1101
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 22, 2014