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

November 18, 2013 updated by: Rutgers, The State University of New Jersey

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: choline magnesium trisalicylate
1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Temporal changes in leukemic cell NF-kB activity
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate
Time Frame: 5 years
5 years
Apoptosis related to NF-kB modulation
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000540303
  • P30CA072720 (U.S. NIH Grant/Contract)
  • 020201 (CINJ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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