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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) Southwest Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004933 |
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 |
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Leukemia |
Drug: hydroxyurea Drug: omacetaxine mepesuccinate |
Phase III |
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 |
Study Start Date: | January 2000 |
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Study Chair: | Meir Wetzler, MD | Roswell Park Cancer Institute |
Study Chair: | Harry P. Erba, MD, PhD | University of Michigan Cancer Center |
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 |
relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia |
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 |
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 |