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Imatinib Mesylate in Treating Patients With Myelofibrosis
This study is ongoing, but not recruiting participants.
First Received: June 6, 2002   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00039416
  Purpose

RATIONALE: Imatinib mesylate may stop the growth of myelofibrosis by blocking certain enzymes necessary for cell growth.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have myelofibrosis.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Leukemia
Drug: imatinib mesylate
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known as STI-571) In Patients With Myelofibrosis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Frequency of adverse events [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Effects of imatinib mesylate on biological markers [ Designated as safety issue: No ]
  • Cytogenetic response [ Designated as safety issue: No ]

Study Start Date: June 2002
Detailed Description:

OBJECTIVES:

  • Determine the complete and partial response rate in patients with myelofibrosis treated with imatinib mesylate.
  • Determine the safety of this drug in these patients.
  • Determine the effects of this drug on the bone marrow morphology, including effects on bone marrow fibrosis, osteosclerosis, and cellularity, in these patients.
  • Assess the effects of this drug on surrogate biologic endpoints, including platelet-derived growth factor (PDGFR) expression by immunohistochemistry, PDGFR signaling, and circulating progenitor (CD34 positive) cells, in these patients.
  • Determine the effects of this drug on bone marrow cytogenetics in patients with an abnormal karyotype.

OUTLINE: This is a multicenter study. Patients are stratified according to Dupriez risk score (low vs intermediate vs high).

Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3-17.5 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • One of the following diagnoses:

    • Histologically confirmed myeloid metaplasia with myelofibrosis (MMM)

      • All subtypes eligible

        • Chronic idiopathic myelofibrosis
        • Agnogenic myeloid metaplasia
        • Post-thrombocythemic or post-polycythemic myelofibrosis
      • Must meet the standard Italian Diagnostic Criteria for MMM OR
  • Histologically confirmed chronic myelomonocytic leukemia (CMMOL) with t(5;12)(q31;p12) or TEL-platelet-derived growth factor (PDGFR)-beta rearrangement

    • Patients with CMMOL and the t(5;7)(q33;q11.2) or other chromosomal translocations resulting in activation of PDGFR are also eligible
    • Must meet the standard World Health Organization Diagnostic Criteria for CMMOL
  • Meets criteria for 1 of the following:

    • Anemia (hemoglobin less than 11 g/dL)
    • Splenomegaly by palpation and ultrasound
  • Philadelphia chromosome or bcr-abl rearrangement negative

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 less than 1.5 times upper limit of normal (ULN)
  • AST/ALT less than 2.5 times ULN (unless due to liver involvement with disease)

Renal:

  • Creatinine less than 2 times ULN

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 barrier contraception during and for up to 3 months after study participation
  • No prior allergic reactions attributed to compounds of similar chemical or biological composition to imatinib mesylate
  • No other uncontrolled concurrent illness
  • No ongoing or active infection
  • No psychiatric illness or social situations that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior epoetin alfa or filgrastim (G-CSF)
  • No concurrent biologic agents

Chemotherapy:

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

Endocrine therapy:

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

Radiotherapy:

  • At least 4 weeks since prior radiotherapy, including splenic irradiation
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • At least 4 weeks since other prior therapy
  • Any number of prior treatment regimens allowed
  • No other concurrent investigational or commercial anticancer agents or therapies
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent therapeutic anticoagulation with warfarin
  • Concurrent therapeutic anticoagulation with low-molecular weight heparin (e.g., enoxaparin) or unfractionated heparin allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039416

Locations
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61615-7828
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46885-5099
United States, Michigan
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States, 49085
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Olatoyosi M. Odenike, MD University of Chicago
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069381, UCCRC-11498A, NCI-5669
Study First Received: June 6, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00039416     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
polycythemia vera
chronic idiopathic myelofibrosis
essential thrombocythemia
chronic myelomonocytic leukemia

Study placed in the following topic categories:
Polycythemia
Polycythemia Vera
Chronic Myelomonocytic Leukemia
Myelofibrosis
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myeloproliferative Disorders
Protein Kinase Inhibitors
Imatinib
Myeloid Metaplasia
Leukemia
Lymphatic Diseases
Metaplasia
Chronic Myeloproliferative Disorders
Thrombocytosis
Hemorrhagic Thrombocythemia
Thrombocythemia, Hemorrhagic
Essential Thrombocytosis
Bone Marrow Diseases

Additional relevant MeSH terms:
Myelofibrosis
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Myeloproliferative Disorders
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Myeloid Metaplasia
Imatinib
Leukemia
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Bone Marrow Diseases
Splenic Diseases

ClinicalTrials.gov processed this record on July 02, 2009