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Sponsors and Collaborators: |
UPMC Cancer Centers National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025415 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have advanced cancer and liver dysfunction.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Gastrointestinal Stromal Tumor Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: imatinib mesylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Pharmacokinetic Study of STI571 in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction |
Study Start Date: | October 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver dysfunction (normal vs mild vs moderate vs severe).
Patients receive oral imatinib mesylate daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients within each stratum (except normal stratum) receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed surgically incurable solid tumor or hematologic malignancy for which no standard or palliative therapy exists or is no longer effective
All tumor types are eligible, including:
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, California | |
City of Hope Medical Group | |
Pasadena, California, United States, 91105 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90033 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 | |
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
United States, Pennsylvania | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 |
Study Chair: | Ramesh K. Ramanathan, MD | UPMC Cancer Centers |
Study ID Numbers: | CDR0000068959, PCI-01-028, MB-NAVY-B01-053, NCI-02-C-0020, NCI-5331 |
Study First Received: | October 11, 2001 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00025415 History of Changes |
Health Authority: | United States: Federal Government |
stage IV adult Hodgkin lymphoma monoclonal gammopathy of undetermined significance recurrent adult Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma Waldenstrom macroglobulinemia stage IV chronic lymphocytic leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia small intestine lymphoma |
unspecified adult solid tumor, protocol specific chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia polycythemia vera chronic idiopathic myelofibrosis essential thrombocythemia Philadelphia chromosome positive chronic myelogenous leukemia untreated hairy cell leukemia progressive hairy cell leukemia, initial treatment refractory hairy cell leukemia chronic myelomonocytic leukemia |
Philadelphia Chromosome Blast Crisis Liver Diseases Mantle Cell Lymphoma Ileal Diseases Preleukemia Leukemia, Prolymphocytic Hemorrhagic Disorders Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Thrombocythemia, Hemorrhagic Myelodysplastic Myeloproliferative Disease Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Leukemia, Myeloid Imatinib Waldenstrom Macroglobulinemia Plasmacytoma Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Precancerous Conditions Blood Protein Disorders Lymphoma, Follicular Sezary Syndrome Lymphoblastic Lymphoma Lymphoma, B-Cell |
Liver Diseases Molecular Mechanisms of Pharmacological Action Precancerous Conditions Antineoplastic Agents Gastrointestinal Diseases Blood Protein Disorders Paraproteinemias Hemostatic Disorders Protein Kinase Inhibitors Ileal Diseases Duodenal Neoplasms Leukemia Preleukemia Neoplasms by Site Pathologic Processes |
Hemorrhagic Disorders Ileal Neoplasms Jejunal Diseases Therapeutic Uses Syndrome Cardiovascular Diseases Lymphoma Duodenal Diseases Jejunal Neoplasms Digestive System Neoplasms Disease Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases |