A Pilot Study of Nuclear Factor-kappa B (NFkB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia (AML)
18 Years
N/A
Both
Leukemia
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 School | New Brunswick, New Jersey 08903 |
