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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: | NCT00091117 |
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib in treating patients with advanced cancer and liver dysfunction.
Condition | Intervention | Phase |
---|---|---|
Liver Cancer Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: bortezomib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Pharmacokinetic Study of PS-341 in Patients With Advanced Malignancies and Varying Degrees of Liver Dysfunction for the CTEP-Sponsored Organ Dysfunction Working Group |
Estimated Enrollment: | 80 |
Study Start Date: | July 2004 |
Estimated Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to hepatic function (normal vs mild dysfunction vs moderate dysfunction vs severe dysfunction).
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients per stratum* receive escalating doses of bortezomib 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.
NOTE: * Patients with normal hepatic function do not receive escalating doses of bortezomib.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Tumor types may include any of the following:
Hepatocellular carcinoma, as evidenced by liver mass, elevated alpha-fetoprotein level (≥ 500 ng/mL), and positive serology for hepatitis
No symptomatic CNS metastases
Brain metastasis allowed if the following criteria are met:
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 Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201-1379 | |
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
United States, New York | |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
Bronx, New York, United States, 10461 | |
Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |
United States, Ohio | |
Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44106-5065 | |
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
United States, Pennsylvania | |
UPMC Cancer Centers | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
United States, Texas | |
University of Texas Health Science Center at San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Contact Person 210-567-4777 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792-6164 | |
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 | |
Australia | |
Sydney Cancer Centre at Royal Prince Alfred Hospital | Recruiting |
Sydney, Australia | |
Contact: Contact Person 61-2-9515-6018 |
Study Chair: | Patricia M. LoRusso, DO | Barbara Ann Karmanos Cancer Institute |
Investigator: | Manuel Valdivieso, MD, MS, CPE | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000383782, WSU-C-2802, NCI-6432 |
Study First Received: | September 7, 2004 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00091117 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific adult primary hepatocellular carcinoma advanced adult primary liver cancer recurrent adult primary liver cancer recurrent adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma stage IV adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma stage IV adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma recurrent adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma |
recurrent adult lymphoblastic lymphoma recurrent marginal zone lymphoma stage IV marginal zone lymphoma recurrent small lymphocytic lymphoma stage IV small lymphocytic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma recurrent mantle cell lymphoma stage IV mantle cell lymphoma adult grade III lymphomatoid granulomatosis Waldenstrom macroglobulinemia |
Liver Diseases Carcinoma, Hepatocellular Lymphoma, Mantle-Cell Lymphoma, Follicular Mantle Cell Lymphoma Lymphoma, B-Cell, Marginal Zone Lymphoblastic Lymphoma Follicular Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Liver Neoplasms Lymphoma, Small Cleaved-cell, Diffuse Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-cell |
Leukemia, B-cell, Chronic Hepatocellular Carcinoma Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphomatoid Granulomatosis Digestive System Neoplasms Immunoproliferative Disorders Bortezomib Recurrence Protease Inhibitors Carcinoma Burkitt's Lymphoma Lymphatic Diseases Chronic Lymphocytic Leukemia Waldenstrom Macroglobulinemia |
Liver Diseases Digestive System Neoplasms Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Bortezomib Enzyme Inhibitors Pharmacologic Actions |
Protease Inhibitors Liver Neoplasms Lymphatic Diseases Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Lymphoproliferative Disorders Lymphoma |