Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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PHASE II STUDY OF SIMULTANEOUS HOMOHARRINGTONINE (NSC 141633) AND ALPHA INTERFERON (IFN-A) THERAPY IN CHRONIC MYELOGENOUS LEUKEMIA (CML)

Conditions
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Leukemia

Intervention / Treatment
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* Biological: recombinant interferon alfa
* Drug: omacetaxine mepesuccinate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523. | Biological: recombinant interferon alfa<br> <br> Drug: omacetaxine mepesuccinate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia