Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Leukemia

Treatments: Biological: recombinant interferon alfa; Drug: omacetaxine mepesuccinate

Study type: Interventional

Funder types: NIH

Identifiers

NCT00002574

NCI-T93-0191D

MDA-DM-93151

NCI-2012-02233

CDR0000063647 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 1 patient group

Arm I

Experimental group

Description:

Single-Agent Chemotherapy plus Biological Response Modifier Therapy. Homoharringtonine, HH, NSC-141633; plus Interferon alfa (Schering), IFN-A, NSC-377523.

Treatment:

Biological: recombinant interferon alfa

Drug: omacetaxine mepesuccinate