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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00101244 |
RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of SB-715992 in treating patients with metastatic or unresectable solid tumors or Hodgkin's or non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: ispinesib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I, Open-Label, Dose-Escalation Study Of SB-715992 Administered Days 1-3 Of A 21-Day Cycle In Patients With Solid Tumors |
Estimated Enrollment: | 31 |
Study Start Date: | March 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation, multicenter study.
Patients receive SB-715992 IV over 1 hour on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SB-715992 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. Up to 10 additional patients are treated at the MTD
Patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 18-31 patients will be accrued for this study within 11-19 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy of 1 of the following types:
Hodgkin's or non-Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 14 days since prior and no concurrent moderate to significant inhibitors or inducers of CYP3A4, including the following:
No concurrent use of any of the following:
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 |
Study Chair: | Patricia M. LoRusso, DO | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000404369, WSU-C-2818, NCI-6785 |
Study First Received: | January 7, 2005 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00101244 |
Health Authority: | United States: Food and Drug Administration |
recurrent adult Hodgkin lymphoma unspecified adult solid tumor, protocol specific stage IV adult Hodgkin lymphoma adult grade III lymphomatoid granulomatosis recurrent adult grade III lymphomatoid granulomatosis splenic marginal zone lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma stage IV adult Burkitt 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 immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma stage IV marginal zone lymphoma stage IV small lymphocytic lymphoma |
Hodgkin's disease Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, B-Cell, Marginal Zone Lymphoma, large-cell, immunoblastic Lymphoma, large-cell Lymphoma, B-Cell Lymphomatoid granulomatosis Burkitt's lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Immunoblastic Waldenstrom macroglobulinemia Hodgkin Disease |
Lymphoma Chronic lymphocytic leukemia Lymphomatoid Granulomatosis Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Leukemia, B-cell, chronic Lymphoblastic lymphoma Mantle cell lymphoma Recurrence Lymphatic Diseases Waldenstrom Macroglobulinemia Burkitt Lymphoma B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoproliferative Disorders |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |