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

Sponsors and Collaborators:	Cancer Institute of New Jersey National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00156299

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 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
Leukemia	Drug: chemotherapy Drug: choline magnesium trisalicylate Genetic: gene expression analysis Other: laboratory biomarker analysis

Study Type:	Interventional
Study Design:	Treatment, Open Label
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:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Choline Choline chloride Trilisate Choline dihydrogen citrate Choline bitartrate Choline salicylate Magnesium

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Temporal changes in leukemic cell NF-kB activity [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Patterns of leukemic cell gene expression [ Designated as safety issue: No ]
Apoptosis related to NF-kB modulation [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	December 2002
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

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, parallel-group study.

Patients receive oral 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

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

Cancer Institute of New Jersey

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Roger Strair, MD, PhD

Cancer Institute of New Jersey

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000540303, CINJ-4158
Study First Received:	September 8, 2005
Last Updated:	May 8, 2009
ClinicalTrials.gov Identifier:	NCT00156299 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Leukemia, Monocytic, Acute
Antimetabolites
Anti-Inflammatory Agents
Choline
Acute Myelomonocytic Leukemia
Salicylates
Acute Monoblastic Leukemia
Leukemia, Myeloid, Acute
Leukemia
Acute Erythroblastic Leukemia
Acute Myelocytic Leukemia
Acute Myeloid Leukemia, Adult
Anti-Inflammatory Agents, Non-Steroidal

Analgesics
Congenital Abnormalities
Nootropic Agents
Antilipemic Agents
Cyclooxygenase Inhibitors
Leukemia, Myeloid
Leukemia, Myelomonocytic, Acute
Choline magnesium trisalicylate
Leukemia, Erythroblastic, Acute
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Di Guglielmo's Syndrome

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Choline
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Salicylates
Leukemia, Myeloid, Acute
Leukemia
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Lipotropic Agents
Nootropic Agents

Neoplasms by Histologic Type
Antilipemic Agents
Cyclooxygenase Inhibitors
Gastrointestinal Agents
Enzyme Inhibitors
Leukemia, Myeloid
Pharmacologic Actions
Choline magnesium trisalicylate
Neoplasms
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009