Clinical trial NCT00002574: Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
Official title: PHASE II STUDY OF SIMULTANEOUS HOMOHARRINGTONINE (NSC 141633) AND ALPHA INTERFERON (IFN-A) THERAPY IN CHRONIC MYELOGENOUS LEUKEMIA (CML)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Keywords: relapsing chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-08-10
Enrollment: 87
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Susan M. O'Brien, MD
role: STUDY_CHAIR
References: