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Sponsors and Collaborators: |
University of Texas National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006221 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of BMS-247550 in treating patients who have malignant solid tumors or lymphoma.
Condition | Intervention | Phase |
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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 Study of BMS-247550 (NSC 710428) Given Weekly X 3 Every 4 Weeks in Patients With Advanced Malignancies |
Study Start Date: | November 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are stratified according to prior therapy (heavily pretreated vs minimally pretreated).
Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level. Patients treated at the MTD receive treatment once weekly on weeks 1-3 of each 4-week course.
Patients are followed within 1 month.
PROJECTED ACCRUAL: Approximately 54 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No symptomatic brain metastases requiring dexamethasone
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, Texas | |
Cancer Therapy and Research Center | |
San Antonio, Texas, United States, 78229 | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78284-7811 | |
Veterans Affairs Medical Center - San Antonio (Murphy) | |
San Antonio, Texas, United States, 78229 |
Study Chair: | Chris H. Takimoto, MD, PhD, FACP | University of Texas |
Study ID Numbers: | CDR0000068141, UTHSC-IDD-99-32, SACI-IDD-99-32, NCI-150 |
Study First Received: | September 11, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006221 |
Health Authority: | United States: Federal Government |
stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma small intestine lymphoma unspecified adult solid tumor, protocol specific stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma stage IV adult T-cell leukemia/lymphoma recurrent adult T-cell leukemia/lymphoma primary central nervous system lymphoma AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma intraocular lymphoma |
Sezary syndrome Lymphoma, Mantle-Cell Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Ileal Diseases Lymphoma, large-cell, immunoblastic Central nervous system lymphoma, primary Duodenal Neoplasms Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Chronic lymphocytic leukemia 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 Sezary Syndrome Mycosis Fungoides |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immune System Diseases Jejunal Diseases |