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


N/A
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Temporal changes in leukemic cell NF-kB activity

Safety Issue:

No

Principal Investigator

Roger Strair, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

CDR0000540303

NCT ID:

NCT00156299

Start Date:

March 2003

Completion Date:

August 2008

Related Keywords:

  • Leukemia
  • 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
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903