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

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Terminated

CT.gov ID

NCT00156299

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Drug: choline magnesium trisalicylate Drug: Dexamethasone	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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)

Study Start Date :

Mar 1, 2003

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Temporal changes in leukemic cell NF-kB activity [5 years]

Secondary Outcome Measures

Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate [5 years]
Apoptosis related to NF-kB modulation [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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