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Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002574
Enrollment
87
Registered
2004-08-10
Start date
1994-09-30
Completion date
Unknown
Last updated
2013-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia

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.

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.

Interventions

BIOLOGICALrecombinant interferon alfa

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026