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

Primary Purpose

Leukemia

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
choline magnesium trisalicylate
Dexamethasone
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dexamethasone plus Choline Magnesium Trisalicylate

Choline Magnesium Trisalicylate

Arm Description

Dexamethasone plus Choline Magnesium Trisalicylate

Choline Magnesium Trisalicylate

Outcomes

Primary Outcome Measures

Temporal changes in leukemic cell NF-kB activity

Secondary Outcome Measures

Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate
Apoptosis related to NF-kB modulation

Full Information

First Posted
September 8, 2005
Last Updated
November 18, 2013
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00156299
Brief Title
Gene Expression During Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Choline Magnesium Trisalicylate
Official Title
A Pilot Study of Nuclear Factor-kappa B (NFkB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia (AML)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Replaced by another study
Study Start Date
March 2003 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone plus Choline Magnesium Trisalicylate
Arm Type
Experimental
Arm Description
Dexamethasone plus Choline Magnesium Trisalicylate
Arm Title
Choline Magnesium Trisalicylate
Arm Type
Experimental
Arm Description
Choline Magnesium Trisalicylate
Intervention Type
Drug
Intervention Name(s)
choline magnesium trisalicylate
Intervention Description
1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
10mg orally every 6 hours beginning at hour 0 and continuing until hour 48.
Primary Outcome Measure Information:
Title
Temporal changes in leukemic cell NF-kB activity
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate
Time Frame
5 years
Title
Apoptosis related to NF-kB modulation
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Strair, MD, PhD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19010875
Citation
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. doi: 10.1158/1078-0432.CCR-08-1390.
Results Reference
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Gene Expression During Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Choline Magnesium Trisalicylate

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