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Sponsors and Collaborators: |
Oregon Health and Science University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00022490 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine to see how well it works in treating patients with chronic phase chronic myelogenous leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: cytarabine Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study To Determine The Anti-Leukemic Effects Of STI571 In Combination With Ara-C In Patients With Chronic Myelogenous Leukemia In Chronic Phase |
Study Start Date: | June 2001 |
OBJECTIVES:
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral imatinib mesylate on days 1-28 and cytarabine subcutaneously on days 15-28. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.
Patients are followed for 30-60 days.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Cytogenetically confirmed chronic phase chronic myelogenous leukemia (CML)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Oregon | |
Cancer Institute at Oregon Health and Science University | |
Portland, Oregon, United States, 97239 |
Study Chair: | Brian J. Druker, MD | Oregon Health and Science University |
Study ID Numbers: | CDR0000068822, OHSU-NCI-4653, NCI-4653 |
Study First Received: | August 10, 2001 |
Last Updated: | April 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00022490 History of Changes |
Health Authority: | United States: Federal Government |
chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia |
Philadelphia Chromosome Antimetabolites Immunologic Factors Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Protein Kinase Inhibitors |
Immunosuppressive Agents Antiviral Agents Imatinib Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Bone Marrow Diseases Cytarabine |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Diseases Physiological Effects of Drugs Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid |
Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Imatinib Leukemia Neoplasms Therapeutic Uses Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Cytarabine |