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

Leukemia Clinical Trial

Official title:

A Pilot Study of Nuclear Factor-kappa B (NFkB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia (AML)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00156299
• Other study ID #: CDR0000540303
• Secondary ID: P30CA07272002020
• Status: Terminated
• Phase: Phase 1
• First received: September 8, 2005
• Last updated: November 18, 2013
• Start date: March 2003
• Est. completion date: July 2008

Study information

• Verified date: November 2013
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid, Acute

Intervention

Drug:
• choline magnesium trisalicylate
1500mg orally every 8 hours beginning at hour 0 and continuing until hour 48.
• Dexamethasone
10mg orally every 6 hours beginning at hour 0 and continuing until hour 48.

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temporal changes in leukemic cell NF-kB activity		5 years	No
Secondary	Patterns of leukemic cell gene expression after administration of choline magnesium trisalicylate		5 years	No
Secondary	Apoptosis related to NF-kB modulation		5 years	No