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Status:

COMPLETED

Bortezomib in Treating Patients With Advanced Myeloproliferative Disorders

Lead Sponsor:

Mayo Clinic

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Chronic Myeloproliferative Disorders

Leukemia

Eligibility:

All Genders

18+ years

Phase:

EARLY_PHASE1

Brief Summary

RATIONALE: Bortezomib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the abnormal cells. PURPOSE: This clinical trial is st...

Detailed Description

OBJECTIVES: Primary * Determine the efficacy of bortezomib in patients with symptomatic advanced myeloproliferative disorders (i.e., myelofibrosis with myeloid metaplasia, chronic myelomonocytic leu...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed advanced myeloproliferative disorder, including 1 of the following subtypes:
  • Myelofibrosis with myeloid metaplasia defined by the following criteria:
  • Evaluable or symptomatic disease as evidenced by ≥ 1 of the following:
  • Anemia, defined as hemoglobin \< 10 g/dL OR erythrocyte-transfusion dependence, defined as requiring 1 transfusion within the past 8 weeks
  • Symptomatic palpable splenomegaly (palpable hepatomegaly is acceptable if previously splenectomized) requiring treatment\* NOTE: \*Subjective but painful enough to mandate intervention
  • Chronic myelomonocytic leukemia (CMML) defined by the following criteria:
  • Absence of an imatinib mesylate-sensitive molecular abnormality for CMML (i.e., t\[5;12\], t\[5;10\], t\[1;5\], and t\[5;7\]) confirmed by fluorescent in situ hybridization (FISH) or standard cytogenetic bone marrow analysis within the past 18 months
  • Symptomatic disease as evidenced by ≥ 1 of the following:
  • Anemia, defined as hemoglobin \< 10 g/dL OR erythrocyte-transfusion dependence, defined as requiring 1 transfusion within the past 8 weeks
  • Palpable splenomegaly (palpable hepatomegaly is acceptable if previously splenectomized) requiring treatment\* NOTE: \*Subjective but painful enough to mandate intervention
  • Leukocytosis associated with ascites, serositis, pleural effusions, vasculitis, or other overt manifestation
  • Systemic mast cell disease defined by the following criteria:
  • Absence of the FIP1LI-PDGFRA mutation as confirmed by FISH
  • Evaluable and symptomatic disease requiring therapy, as evidenced by involvement with organs other than skin (i.e., heart, bowel, peripheral blood, liver/spleen, or marrow)
  • Debilitating mast cell mediator symptoms not responsive to standard therapy such as antihistamines
  • Absence of t(9;22) translocation as confirmed by FISH or standard cytogenetic peripheral blood or marrow analysis at any prior time point
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Not incarcerated in a municipal, county, state, or federal prison
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 75,000/mm³
  • Creatinine ≤ 2.0 mg/dL
  • Total or direct bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 3 times upper limit of normal (unless clinically attributed to hepatic extramedullary hematopoiesis)
  • No baseline peripheral or autonomic neuropathy ≥ grade 2
  • No other condition or laboratory abnormality that would place the patient at unacceptable risk or confound the ability to interpret study data
  • No hypersensitivity to boron, mannitol, or bortezomib
  • No myocardial infarction within the past 6 months
  • No New York Hospital Association class III-IV heart failure
  • No uncontrolled angina
  • No severe uncontrolled ventricular arrhythmia
  • No evidence of acute ischemia or active conduction system abnormality by ECG
  • ECG screening abnormalities must be documented as not medically relevant
  • No other serious medical or psychiatric illness that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • At least 14 days since prior chemotherapy (e.g., interferon alfa, anagrelide, or other myelosuppressive agent) or any other experimental therapy
  • At least 14 days since prior growth factors
  • At least 14 days since prior systemic use of corticosteroids
  • More than 14 days since prior investigational drugs
  • Concurrent hydroxyurea allowed for ≤ 14 days during study therapy if clinically indicated for extreme leukocytosis control

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    November 1 2008

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00437086

    Start Date

    September 1 2005

    End Date

    November 1 2008

    Last Update

    October 17 2014

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Mayo Clinic in Florida

    Jacksonville, Florida, United States, 32224

    2

    Mayo Clinic

    Rochester, Minnesota, United States, 55905

    3

    M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, United States, 77030-4009