Full Text View
Tabular View
No Study Results Posted
Related Studies
Homoharringtonine in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
This study has been completed.
First Received: October 4, 2000   Last Updated: December 13, 2008   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006364
  Purpose

RATIONALE: Drugs used in chemotherapy, such as homoharringtonine, work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of homoharringtonine in treating patients who have chronic phase chronic myelogenous leukemia.


Condition Intervention Phase
Leukemia
Drug: omacetaxine mepesuccinate
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase I and Pilot Study of Subcutaneous Homoharringtonine in Chronic Myelogenous Leukemia (CML)

Resource links provided by NLM:


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

Study Start Date: November 1999
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of homoharringtonine in patients with transformed phases of chronic myelogenous leukemia (CML). (Phase I completed as of 2/11/2004.)
  • Determine the toxicity profile of this drug in these patients.
  • Determine the response duration in patients with chronic phase CML treated with this drug.
  • Compare the pharmacokinetics of this drug administered as a continuous infusion vs subcutaneously in these patients.

OUTLINE: This is a pilot, dose-escalation study. (Phase I completed as of 2/11/2004.)

  • Remission induction therapy: Patients receive remission induction therapy comprising homoharringtonine IV continuously over 24 hours on day 1 and then subcutaneously (SC) twice daily on days 2-14 for course 1. Subsequent courses of remission induction therapy comprise homoharringtonine SC twice daily on days 1-14. Treatment continues monthly for at least 2 courses.
  • Maintenance therapy: Patients with complete hematologic remission receive maintenance therapy comprising homoharringtonine SC twice daily on days 1-7 monthly for 3 years in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of homoharringtonine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. An additional cohort of 25-30 patients with chronic phase chronic myelogenous leukemia receives remission induction and maintenance therapy as above at the MTD. (Phase I completed as of 2/11/2004.)

Patients are followed every 3 months.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic phase chronic myelogenous leukemia (CML), as defined by the following:

    • Less than 15% blasts in the peripheral blood (PB) or bone marrow (BM)
    • Less than 20% basophils in the PB or BM
    • Platelet count > 100,000/mm^3 (unless related to therapy)
    • Absence of clonal evolution* NOTE: * Patients with variant Philadelphia chromosome or deletions of chromosome Y (-Y) are eligible if there is no chromosomal change representing clonal evolution
  • Philadelphia chromosome- OR BCR/ABL-positive disease by cytogenetics, fluorescence in situ hybridization, or polymerase chain reaction
  • Failed prior therapy with imatinib mesylate, as defined by any of the following:

    • Failed to achieve or have lost a complete hematologic remission after 3 months of therapy
    • Failed to achieve or have lost at least a minimal cytogenetic response after 6 months of therapy
    • Failed to achieve or have lost a major or complete cytogenetic response after 12 months of therapy
    • Unable to tolerate imatinib mesylate despite adequate dose adjustment
  • Failed no more than 2 prior treatment regimens (in addition to imatinib mesylate)

    • Treatment with hydroxyurea is not considered one regimen
  • Ineligible for known regimens or protocols of higher efficacy or priority

PATIENT CHARACTERISTICS:

Age:

  • 12 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 2 months

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL

Renal:

  • Creatinine less than 2.0 mg/dL

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006364

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Jorge Cortes, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Quintas-Cardama A, Kantarjian H, Garcia-Manero G, O'Brien S, Faderl S, Estrov Z, Giles F, Murgo A, Ladie N, Verstovsek S, Cortes J. Phase I/II study of subcutaneous homoharringtonine in patients with chronic myeloid leukemia who have failed prior therapy. Cancer. 2007 Jan 15;109(2):248-55.
Quintas-Cardama A, Cortes J, Verstovsek S, et al.: Subcutaneous (SC) homoharringtonine (HHT) for patients (pts) with chronic myelogenous leukemia (CML) in chronic phase (CP) after imatinib mesylate failure. [Abstract] Blood 106 (11): A-4839, 2005 .

Study ID Numbers: CDR0000068237, MDA-ID-99032, MDA-FDR001783, NCI-T99-0044
Study First Received: October 4, 2000
Last Updated: December 13, 2008
ClinicalTrials.gov Identifier: NCT00006364     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
relapsing chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
childhood chronic myelogenous leukemia

Study placed in the following topic categories:
Philadelphia Chromosome
Leukemia
Hematologic Diseases
Homoharringtonine
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Myelogenous Leukemia
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Hematologic Diseases
Homoharringtonine
Growth Substances
Physiological Effects of Drugs
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Angiogenesis Inhibitors
Pharmacologic Actions
Leukemia
Neoplasms
Therapeutic Uses
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Growth Inhibitors
Angiogenesis Modulating Agents
Bone Marrow Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 02, 2009