Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00002574

Collaborator

(none)

Enrollment

Locations

Arm

43.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Biological: recombinant interferon alfa Drug: omacetaxine mepesuccinate	Phase 2

Detailed Description

OBJECTIVES:

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 Design

Study Type:

Interventional

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 :

Sep 1, 1994

Actual Primary Completion Date :

Jun 1, 2001

Arms and Interventions

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.	Biological: recombinant interferon alfa Drug: omacetaxine mepesuccinate

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.

Biological: recombinant interferon alfa

Drug: omacetaxine mepesuccinate

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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