Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002574
• Other study ID #: NCI-2012-02233
• Secondary ID: MDA-DM-93151NCI-
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 4, 2013
• Start date: September 1994

Study information

• Verified date: October 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. primary completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Biological:
• recombinant interferon alfa

Drug:
• omacetaxine mepesuccinate

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,