Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

February 4, 2013 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas - MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Susan M. O'Brien, MD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1994

Primary Completion (Actual)

June 1, 2001

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 9, 2004

First Posted (Estimate)

August 10, 2004

Study Record Updates

Last Update Posted (Estimate)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

October 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02233
  • MDA-DM-93151
  • NCI-T93-0191D
  • CDR0000063647 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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