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Decitabine in Treating Patients With Myelofibrosis
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2007
First Received: November 9, 2004   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00095784
  Purpose

RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well decitabine works in treating patients with myelofibrosis.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Drug: decitabine
Phase II

MedlinePlus related topics: Cancer Spleen Diseases
Drug Information available for: 5-Aza-2'-deoxycytidine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Decitabine in Myelofibrosis

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

Primary Outcome Measures:
  • Response rate (complete response, partial response, hematologic improvement) [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: September 2004
Estimated Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine response rate (complete and partial response and hematological improvement) in patients with myeloid metaplasia with myelofibrosis treated with decitabine.
  • Determine the safety of this drug in these patients.

OUTLINE: This is a multicenter study.

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

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 10 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed myeloid metaplasia with myelofibrosis (MMM), including all of the following subtypes:

    • Chronic idiopathic myelofibrosis
    • Agnogenic myeloid metaplasia
    • Post-thrombocythemic myelofibrosis
    • Post-polycythemic myelofibrosis
  • Diffuse bone marrow fibrosis
  • Absence of Philadelphia chromosome OR BCR-ABL rearrangement in peripheral blood cells
  • Meets 1 of the following criteria:

    • Anemia (hemoglobin < 11 g/dL)
    • Palpable splenomegaly* NOTE: *Patients with palpable splenomegaly must have spleen size documented ultrasonographically AND meet standard criteria for MMM
  • Morphologic evidence of advanced phase disease, including accelerated phase (10-19% blasts), or evidence of evolution to acute leukemia (≥ 20% blasts) allowed
  • No known CNS disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin ≤ 2 mg/dL unless associated with hemolytic anemia as a result of predominantly unconjugated hyperbilirubinemia
  • AST and ALT ≤ 3 times upper limit of normal (unless due to disease)

Renal

  • Creatinine ≤ 2 mg/dL

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to decitabine
  • No ongoing or active infection
  • No other uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 2 weeks since prior growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF])
  • No concurrent prophylactic G-CSF or GM-CSF
  • No concurrent epoetin alfa

Chemotherapy

  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
  • No prior decitabine
  • No other concurrent chemotherapy

Endocrine therapy

  • At least 4 weeks since prior androgenic steroids
  • No concurrent androgenic steroids

Radiotherapy

  • Prior splenic irradiation allowed
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • Recovered from all prior therapy
  • At least 4 weeks since other prior therapy
  • No other concurrent investigational agents
  • No other concurrent antineoplastic agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00095784

Locations
United States, Illinois
Central Illinois Hematology Oncology Center Recruiting
Springfield, Illinois, United States, 62701
Contact: Edem S. Agamah, MD, MS     217-525-2500     ihdn@aol.com    
Decatur Memorial Hospital Cancer Care Institute Recruiting
Decatur, Illinois, United States, 62526
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care     217-876-6601        
Evanston Northwestern Healthcare - Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201-1781
Contact: Clinical Trials Office - Evanston Northwestern Healthcare - Ev     847-570-1381        
Ingalls Cancer Care Center at Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Clinical Trials Office - Ingalls Cancer Care Center at Ingalls     708-915-6747        
Oncology Hematology Associates of Central Illinois, PC - Peoria Recruiting
Peoria, Illinois, United States, 61615-7828
Contact: John W. Kugler, MD     309-243-3605     jkugler@ohaci.com    
Simmons Cooper Cancer Institute Recruiting
Springfield, Illinois, United States, 62794-9677
Contact: Clinical Trials Office - Simmons Cooper Cancer Institute     217-545-7929        
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research     773-834-7424        
United States, Indiana
CCOP - Northern Indiana CR Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: David A. Taber, MD     574-647-3353        
Fort Wayne Medical Oncology and Hematology Recruiting
Fort Wayne, Indiana, United States, 46885-5099
Contact: David F. Sciortino, MD     260-484-8830        
United States, Michigan
Oncology Care Associates, PLLC Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Eric P. Lester, MD     269-985-0029        
United States, Wisconsin
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C     414-805-4380        
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Olatoyosi M. Odenike, MD University of Chicago
  More Information

Additional Information:
No publications provided

Responsible Party: University of Chicago Cancer Research Center ( Everett E. Vokes )
Study ID Numbers: CDR0000393839, UCCRC-13327A, NCI-6814
Study First Received: November 9, 2004
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00095784     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
chronic idiopathic myelofibrosis

Study placed in the following topic categories:
Antimetabolites
Myeloid Metaplasia
Lymphatic Diseases
Myelofibrosis
Hematologic Diseases
Metaplasia
Chronic Myeloproliferative Disorders
Myeloproliferative Disorders
Decitabine
Bone Marrow Diseases

Additional relevant MeSH terms:
Antimetabolites
Myelofibrosis
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Hematologic Diseases
Antineoplastic Agents
Myeloproliferative Disorders
Enzyme Inhibitors
Decitabine
Pharmacologic Actions
Myeloid Metaplasia
Lymphatic Diseases
Therapeutic Uses
Bone Marrow Diseases
Splenic Diseases

ClinicalTrials.gov processed this record on May 07, 2009