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Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002574
Recruitment Status : Completed
First Posted : August 10, 2004
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
Phase II trial to study the effectiveness of homoharringtonine and interferon alfa in treating patients with chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells.

Condition or disease Intervention/treatment Phase
Leukemia Biological: recombinant interferon alfa Drug: omacetaxine mepesuccinate Phase 2

Detailed Description:

OBJECTIVES:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PHASE II STUDY OF SIMULTANEOUS HOMOHARRINGTONINE (NSC 141633) AND ALPHA INTERFERON (IFN-A) THERAPY IN CHRONIC MYELOGENOUS LEUKEMIA (CML)
Study Start Date : September 1994
Actual Primary Completion Date : June 2001

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I
Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523.
 Biological: recombinant interferon alfa
Drug: omacetaxine mepesuccinate


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Chronic myelogenous leukemia (CML) in chronic phase
  • Clonal evolution (i.e., the presence of clones other than the Ph chromosome) allowed Ph chromosome variants or complex Ph chromosome translocations are not considered disease acceleration
  • Ineligible for known therapy of higher efficacy or priority
  • Allogeneic bone marrow transplantation should be considered priority therapy for CML patients with a matched related donor
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002574


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Study Chair: Susan M. O'Brien, MD M.D. Anderson Cancer Center
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002574    
Other Study ID Numbers: NCI-2012-02233
MDA-DM-93151
NCI-T93-0191D
CDR0000063647 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: August 10, 2004    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: October 2001
Keywords provided by National Cancer Institute (NCI):
relapsing chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Interferons
Interferon-alpha
 Homoharringtonine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action