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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00025415 |
Purpose
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 |
|---|---|---|
|
Chronic Myeloproliferative Disorders Gastrointestinal Stromal Tumor Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Precancerous Condition Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: imatinib mesylate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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.
Eligibility| 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:
Contacts and Locations| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033 | |
| City of Hope Medical Group | |
| Pasadena, California, United States, 91105 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| 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 | University of Pittsburgh |
More Information
| ClinicalTrials.gov Identifier: | NCT00025415 History of Changes |
| Obsolete Identifiers: | NCT00025948 |
| Other 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: | June 4, 2011 |
| 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 primary myelofibrosis essential thrombocythemia chronic myelogenous leukemia, BCR-ABL1 positive untreated hairy cell leukemia progressive hairy cell leukemia, initial treatment refractory hairy cell leukemia chronic myelomonocytic leukemia |
|
Neoplasms Disease Leukemia Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Precancerous Conditions Lymphoma, Large-Cell, Immunoblastic Liver Diseases Duodenal Neoplasms |
Ileal Neoplasms Jejunal Neoplasms Gastrointestinal Stromal Tumors Intestinal Neoplasms Myelodysplastic-Myeloproliferative Diseases Pathologic Processes Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias |