Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
NCT ID: NCT00002574
Last Updated: 2013-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
87 participants
INTERVENTIONAL
1994-09-30
Brief Summary
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Detailed Description
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I. Determine the efficacy of homoharringtonine administered simultaneously with interferon alpha in achieving complete cytogenetic response in patients with chronic myelogenous leukemia in chronic phase.
OUTLINE:
Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I
Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523.
recombinant interferon alfa
omacetaxine mepesuccinate
Interventions
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recombinant interferon alfa
omacetaxine mepesuccinate
Eligibility Criteria
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Inclusion Criteria
* No blastic phase CML (30% or more blasts in peripheral blood or bone marrow)
* No accelerated phase CML, defined as any of the following: 15% or more peripheral or marrow blasts or 30% or more blasts and promyelocytes 20% or more peripheral or marrow basophils
* Thrombocytopenia (platelets less than 100,000) unrelated to therapy
* Documented extramedullary disease outside of liver or spleen
PATIENT CHARACTERISTICS:
* Age: 15 and over
* Performance status: Zubrod 0-2
* Life expectancy: Sufficient to fully evaluate the effects of 2 courses of therapy
* Bilirubin no greater than 2.0 mg/dL
* SGOT less than 300
* Creatinine less than 2.0 mg/dL OR creatinine clearance at least 60 mL/min
* No severe heart disease (class III/IV)
* No pregnant or nursing women
* Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY:
* No prior interferon alpha
* At least 2 weeks since antileukemic therapy, with recovery required
* Patients who received hydroxyurea within the past 2 weeks and have WBC greater than 50,000 may enter protocol after discussion with the primary investigator
15 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Susan M. O'Brien, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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MDA-DM-93151
Identifier Type: -
Identifier Source: secondary_id
NCI-T93-0191D
Identifier Type: -
Identifier Source: secondary_id
CDR0000063647
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02233
Identifier Type: -
Identifier Source: org_study_id
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