Homoharringtonine and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002574
First received: November 1, 1999
Last updated: February 4, 2013
Last verified: October 2001
  Purpose

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 Intervention Phase
Leukemia
Biological: recombinant interferon alfa
Drug: omacetaxine mepesuccinate
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 87
Study Start Date: September 1994
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002574

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Study Chair: Susan M. O'Brien, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002574     History of Changes
Other Study ID Numbers: NCI-2012-02233, MDA-DM-93151, NCI-T93-0191D, CDR0000063647
Study First Received: November 1, 1999
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
relapsing chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Homoharringtonine
Harringtonines
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 16, 2014