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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045422 |
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining interferon alfa with imatinib mesylate may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with imatinib mesylate in treating patients who have chronic myelogenous leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: imatinib mesylate Drug: recombinant interferon alfa |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Open Label Study to Determine Safety and Efficacy of Interferon-Alpha in Combination With Imantinib Mesylate (Gleevec) in Patients With Chronic Phase Chronic Myelogenous Leukemia Who Have Not Achieved a Complete Cytogenetic Response to Gleevec as a Single Agent |
Study Start Date: | April 2002 |
OBJECTIVES:
OUTLINE: Patients receive oral imatinib mesylate (STI-571) once daily for 9 months. At 9 months, patients with more than 35% Philadelphia chromosome-positive (Ph+) cells in bone marrow receive oral STI-571 twice daily for 3 more months. At 12 months, patients with more than 35% Ph+ cells in bone marrow receive oral STI-571 once daily and interferon alfa subcutaneously once daily. Treatment continues for at least 1 year in the absence of disease progression or unacceptable toxicity. Patients with an appropriate HLA-matched donor may choose to have a bone marrow transplantation at any time during the study.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 80 patients (60 without an HLA-matched donor and 20 with an HLA-matched donor) will be accrued for this study within 5 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic phase chronic myelogenous leukemia
Cytogenetically confirmed Philadelphia chromosome-positive disease or other variant of t(9;22)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Ellin Berman, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000256469, MSKCC-02013, NCI-G02-2105 |
Study First Received: | September 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00045422 |
Health Authority: | United States: Federal Government |
Philadelphia chromosome positive chronic myelogenous leukemia chronic phase chronic myelogenous leukemia childhood chronic myelogenous leukemia |
Philadelphia Chromosome Interferon-alpha Interferon Type I, Recombinant Chronic myelogenous leukemia Hematologic Diseases Interferons Myeloproliferative Disorders |
Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Imatinib Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Interferon Alfa-2a |
Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |