Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
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ClinicalTrials.gov Identifier: NCT00002574 |
Recruitment Status :
Completed
First Posted : August 10, 2004
Last Update Posted : February 5, 2013
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Condition or disease | Intervention/treatment | Phase |
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Leukemia | Biological: recombinant interferon alfa Drug: omacetaxine mepesuccinate | Phase 2 |
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 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 |

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.
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Biological: recombinant interferon alfa Drug: omacetaxine mepesuccinate |

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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 |
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

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
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 |
Study Chair: | Susan M. O'Brien, MD | M.D. Anderson Cancer Center |
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 |
relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia |
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 |