Decitabine in Treating Patients With Myelofibrosis



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/8/2019
Start Date:September 29, 2004

Use our guide to learn which trials are right for you!

A Phase II Study of Decitabine in Myelofibrosis

This phase II trial studies the side effects and how well decitabine works in treating
patients with myelofibrosis, a cancer of the blood system associated with fibrosis (scar
tissue) in the bone marrow that is advanced and for which there is no standard therapy.
Decitabine may block the actions of some proteins that are responsible for turning certain
genes off in various cancers including myelofibrosis.

PRIMARY OBJECTIVES:

I. To determine response rate (complete and partial responses and hematological improvement)
to decitabine in patients with myelofibrosis.

II. To determine the safety of decitabine in patients with myelofibrosis.

SECONDARY OBJECTIVES:

I. To determine the effects of decitabine on specific epigenetic changes including
methylation status of specific target genes and gene re-expression.

II. To determine the effect of decitabine on hemoglobin F levels and on the absolute numbers
of circulating cluster of differentiation (CD) 34+ progenitor cells and to investigate the
potential utility of these markers as a surrogate for biologic activity of decitabine in
myeloid metaplasia with myelofibrosis (MMM).

OUTLINE:

Patients receive decitabine subcutaneously (SC) on days 1-5 and 8-12. Treatment repeats every
42 days in the absence of disease progression or unacceptable toxicity.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed myeloid metaplasia with
myelofibrosis (this includes all subtypes - chronic idiopathic myelofibrosis or
angiogenic myeloid metaplasia, post thrombocythemic and post polycythemic
myelofibrosis); patients must have anemia (hemoglobin < 11 g/dL) or palpable
splenomegaly (measured in cm from costal margin - to be eligible); patients with
palpable splenomegaly must have spleen size documented ultrasonographically as well;
they must also meet standard diagnostic criteria for MMM

- Patients with morphologic evidence of advanced phases of the disease including
accelerated (10-19% blasts) phase or with evidence of evolution to acute leukemia (>=
20% blasts) are also eligible for this study

- The Italian Diagnostic Criteria for MMM

- Necessary criteria

- Diffuse bone marrow fibrosis

- Absence of the Philadelphia chromosome or BCR-ABL rearrangement in
peripheral blood cells

- Optional criteria

- Splenomegaly of any grade

- Anisopoikilocytosis with tear drop erythrocytes

- Presence of circulating immature myeloid cells

- Presence of circulating erythroblasts

- Presence of clusters of megakaryoblasts and anomalous megakaryocytes in bone
marrow sections

- Myeloid metaplasia

- Diagnosis of MMM is acceptable if the following combinations are present

- The two necessary criteria plus any other two optional criteria when
splenomegaly is present OR

- The two necessary criteria plus any other four optional criteria when
splenomegaly is absent

- Patients may have had prior chemotherapy or radiation therapy including splenic
irradiation; prior therapy with erythropoietin, granulocyte-colony stimulating factor
(GCSF), other growth factors or androgenic steroids is also permitted; there is no
limit to the number of prior regimens received; at least 4 weeks must have elapsed
since prior chemo or radiation therapy; at least 2 weeks must have elapsed since
growth factor (erythropoietin, GCSF, granulocyte-macrophage colony-stimulating factor
[GM-CSF]) or other therapy

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

- Total bilirubin =< 2mg/dL

- In patients with associated hemolytic anemia; total bilirubin > 2mg/dL is
permissible as long as this is as a result of predominantly unconjugated
hyperbilirubinemia; such patients may be enrolled only after discussion with the
study chair

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 3 x institutional upper limit of normal unless due to disease

- Serum creatinine =< 2mg/dL

- Patients must not be pregnant or nursing; women of child- bearing potential and men
must agree to use an effective contraceptive method; should a woman become pregnant or
suspect she is pregnant while participating in this study, she should inform her
treating physician immediately

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Prior therapy with decitabine

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier

- Patients may not be receiving any other investigational agents

- Patients with known central nervous system (CNS) disease should be excluded from this
clinical trial

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to decitabine

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued if
the mother is treated with decitabine

- Human immunodeficiency virus (HIV)-positive patients receiving combination
anti-retroviral therapy are excluded from the study
We found this trial at
14
sites
8940 Wood Sage Rd
Peoria, Illinois 61615
(309) 243-3000
Illinois CancerCare-Peoria Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
?
mi
from
Peoria, IL
Click here to add this to my saved trials
22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
?
mi
from
Decatur, IL
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
?
mi
from
Harvey, IL
Click here to add this to my saved trials
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
?
mi
from
Maywood, IL
Click here to add this to my saved trials
9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Saint Joseph, Michigan 49085
?
mi
from
Saint Joseph, MI
Click here to add this to my saved trials
615 N Michigan Street
South Bend, Indiana 46601
(574) 647-7370
Northern Indiana Cancer Research Consortium The Northern Indiana Cancer Research Consortium (NICRC) is comprised of...
?
mi
from
South Bend, IN
Click here to add this to my saved trials
Springfield, Illinois 62701
?
mi
from
Springfield, IL
Click here to add this to my saved trials
801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
?
mi
from
Springfield, IL
Click here to add this to my saved trials