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Homoharringtonine Compared With Hydroxyurea for Chronic Myelogenous Leukemia That Has Not Responded to Interferon Alfa
This study is ongoing, but not recruiting participants.
First Received: March 7, 2000   Last Updated: December 13, 2008   History of Changes
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Southwest Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004933
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if homoharringtonine is more effective than hydroxyurea for chronic myelogenous leukemia that has not responded to interferon alfa.

PURPOSE: Randomized phase III trial to compare the effectiveness of homoharringtonine with that of hydroxyurea in treating patients who have chronic myelogenous leukemia that has not responded to interferon alfa.


Condition Intervention Phase
Leukemia
Drug: hydroxyurea
Drug: omacetaxine mepesuccinate
Phase III

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Homoharringtonine Hydroxyurea Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
Official Title:

A Phase III Study of Interferon-Refractory Patients With BCR/ABL(+) Chronic Myelogenous Leukemia (CML) Treated With Homoharringtonine (NSC #141633) vs.

Hydroxyurea


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

Study Start Date: January 2000
Detailed Description:

OBJECTIVES: I. Compare the overall survival of interferon alfa refractory chronic myelogenous leukemia patients treated with homoharringtonine to those treated with hydroxyurea. II. Compare the time to progression of these patients treated with these two drugs. III. Estimate the complete and major cytogenetic response and describe the serial cytogenetics of these patients treated with these two drugs.

OUTLINE: This is a randomized study. Patients are randomized to receive one of two treatments. Arm I: Induction: Patients receive homoharringtonine IV continuously over 24 hours daily for 14 days. Induction continues every 28 days for a maximum of 6 courses or until hematopoietic recovery. Maintenance: Patients receive homoharringtonine IV continuously over 24 hours daily for 5 days. Treatment repeats every 28 days. Arm II: Induction: Patients receive oral hydroxyurea daily for 28 days until acceptable blood counts are achieved. Maintenance: Patients receive oral hydroxyurea daily every 28 days to maintain acceptable blood counts. Treatment in both arms continues for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for a maximum of 10 years.

PROJECTED ACCRUAL: A total of 480 patients (240 per arm) will be accrued for this study within 4 years.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Cytologically proven chronic phase chronic myelogenous leukemia Philadelphia chromosome detectable by cytogenetic studies OR 1 of the following: BCR/ABL protein detectable by immunoblotting BCR/ABL rearrangement detectable by Southern blot analysis Polymerase chain reaction positive fusion transcripts for BCR/ABL BCR/ABL translocation present by fluorescence in situ hybridization No prior intolerance or failure to respond to hydroxyurea Must have failed adequate trial (5M units/m2/day) of interferon alfa (IFN) or the combination of IFN and cytarabine as defined by 1 of the following: Failure to achieve complete hematologic response after 6 months of IFN Failure to achieve any cytogenetic response (i.e., still 100% Philadelphia chromosome positive) after 12 months of IFN Intolerable adverse effects of IFN after at least 1 month of IFN Significant documented toxicity of grade 3 or greater due to IFN required Loss of a prior hematologic remission or cytogenetic response to IFN Two-fold increase in WBC count compared to WBC count when IFN initiated

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled tachyarrhythmias (e.g., atrial fibrillation, paroxysmal superventricular tachycardia, or ventricular tachycardias not adequately controlled) Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior interferon alfa Chemotherapy: See Disease Characteristics No prior homoharringtonine Less than 180 days cumulative prior hydroxyurea No more than 60 days hydroxyurea after failing interferon Endocrine therapy: No concurrent hormones except for nondisease related conditions (e.g., insulin for diabetes, estrogen for osteopenia) Concurrent steroids for adrenal failure allowed Radiotherapy: No concurrent palliative radiotherapy Surgery: No concurrent splenectomy except for emergency management

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004933

  Show 133 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Southwest Oncology Group
Investigators
Study Chair: Meir Wetzler, MD Roswell Park Cancer Institute
Study Chair: Harry P. Erba, MD, PhD University of Michigan Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067617, CLB-19807, SWOG-C19807
Study First Received: March 7, 2000
Last Updated: December 13, 2008
ClinicalTrials.gov Identifier: NCT00004933     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

Study placed in the following topic categories:
Philadelphia Chromosome
Interferon-alpha
Hydroxyurea
Hematologic Diseases
Homoharringtonine
Interferons
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Angiogenesis Inhibitors
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chronic Myelogenous Leukemia
Bone Marrow Diseases
Interferon Alfa-2a
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Antisickling Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Hematologic Diseases
Hydroxyurea
Antineoplastic Agents
Growth Substances
Homoharringtonine
Physiological Effects of Drugs
Hematologic Agents
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
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
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009