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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049400 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone in treating patients with advanced solid tumors or lymphomas and liver dysfunction.
Condition | Intervention | Phase |
---|---|---|
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: ixabepilone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Pharmacokinetic Study Of Epothilone B Analogue BMS-247550 (NSC 710428D) In Patients With Advanced Malignancies And Varying Levels Of Liver Dysfunction |
Estimated Enrollment: | 84 |
Study Start Date: | October 2003 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to liver function (normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction).
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 but no more than 12 patients are treated at the recommended phase II dose.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 12-84 patients (6-12 for stratum 1; 2-18 for stratum 2; 2-24 for stratum 3; and 2-30 for stratum 4) will be accrued for this study within 12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective
Patients with glioma or brain metastases must be on a stable dose of corticosteroids and be seizure-free for the past month
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent hormone therapy for malignancy
Radiotherapy
Surgery
Other
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90089-9181 | |
United States, Illinois | |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
United States, Kansas | |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160-7357 | |
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106 | |
Cleveland Clinic - Wooster | |
Wooster, Ohio, United States, 44691 | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
Community Oncology Group at Cleveland Clinic Cancer Center | |
Independence, Ohio, United States, 44131 | |
United States, Texas | |
Brooke Army Medical Center | |
Fort Sam Houston, Texas, United States, 78234 | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78229-3900 | |
Wilford Hall Medical Center | |
Lackland AFB, Texas, United States, 78236 | |
United States, Washington | |
Cancer Care Northwest - Spokane South | |
Spokane, Washington, United States, 99202 | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98104 | |
Group Health Central Hospital | |
Seattle, Washington, United States, 98104-1387 | |
Harborview Medical Center | |
Seattle, Washington, United States, 98104 | |
North Puget Oncology at United General Hospital | |
Sedro-Wooley, Washington, United States, 98284 | |
Wenatchee Valley Medical Center | |
Wenatchee, Washington, United States, 98801-2028 | |
Skagit Valley Hospital Cancer Care Center | |
Mt. Vernon, Washington, United States, 98273 | |
St. Joseph Hospital Community Cancer Center | |
Bellingham, Washington, United States, 98225 | |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
Seattle, Washington, United States, 98122-4307 | |
University Cancer Center at University of Washington Medical Center | |
Seattle, Washington, United States, 98195-6043 | |
Olympic Hematology and Oncology | |
Bremerton, Washington, United States, 98310 |
Investigator: | Angela Davies, MD | University of California, Davis |
Investigator: | Chris H. Takimoto, MD, PhD, FACP | Institute for Drug Development |
Study ID Numbers: | CDR0000258060, SWOG-S0355, NCI-5707, NYU-0132 |
Study First Received: | November 12, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00049400 |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma intraocular lymphoma primary central nervous system lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult T-cell leukemia/lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma |
recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma small intestine lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult Burkitt lymphoma stage IV adult Hodgkin lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult T-cell leukemia/lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma |
Liver Diseases Lymphoma, Mantle-Cell Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Ileal Diseases Lymphoma, large-cell, immunoblastic Central nervous system lymphoma, primary Duodenal Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Chronic lymphocytic leukemia Epothilone B Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders |
Digestive System Neoplasms Leukemia, B-cell, chronic B-cell lymphomas Leukemia, T-Cell Gastrointestinal Neoplasms Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Hodgkin's disease Gastrointestinal Diseases Cutaneous T-cell lymphoma Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Lymphoma, B-Cell Lymphoma, large-cell |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Jejunal Diseases Therapeutic Uses Mitosis Modulators Tubulin Modulators Antimitotic Agents Pharmacologic Actions |