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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303966 |
RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with relapsed chronic lymphocytic leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Study of BAY 43-9006 in Relapsed Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 37 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 40 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:
Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) by NCI-WG immunophenotype and blood criteria
Documentation of current or prior peripheral blood (PB) or bone marrow (BM) immunophenotype compatible with CLL
Intermediate-risk (Rai stage I or II) or high-risk (Rai stage III or IV) disease, including any of the following:
Must require treatment with active disease, experiencing disease related symptoms, or having deterioration of blood counts, meeting ≥ 1 of the following criteria:
Presence of ≥ 1 of the following disease-related symptoms:
Relapsed disease
Must receive at least 1, but no more than 3, prior chemotherapy regimens with any cytotoxic agent or antibody therapy
No fludarabine refractory disease
PATIENT CHARACTERISTICS:
No uncontrolled hypertension, defined as blood pressure (BP) > 150/100 mm Hg on 2 different measurements at least 1 day apart with either systolic or diastolic number meeting this definition
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Concurrent warfarin for anticoagulation allowed provided all of the following are met:
United States, Illinois | |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Decatur Memorial Hospital Cancer Care Institute | |
Decatur, Illinois, United States, 62526 | |
Evanston Northwestern Healthcare - Evanston Hospital | |
Evanston, Illinois, United States, 60201-1781 | |
Simmons Cooper Cancer Institute | |
Springfield, Illinois, United States, 62794-9677 | |
Joliet Oncology-Hematology Associates, Limited - West | |
Joliet, Illinois, United States, 60435 | |
Oncology Hematology Associates of Central Illinois, PC - Peoria | |
Peoria, Illinois, United States, 61615-7828 | |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
Fort Wayne Medical Oncology and Hematology | |
Fort Wayne, Indiana, United States, 46885-5099 | |
United States, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 | |
United States, Michigan | |
Oncology Care Associates, PLLC | |
Saint Joseph, Michigan, United States, 49085 | |
University of Michigan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109-0942 | |
United States, Missouri | |
David C. Pratt Cancer Center at St. John's Mercy | |
Saint Louis, Missouri, United States, 63141 | |
United States, Wisconsin | |
Medical College of Wisconsin Cancer Center | |
Milwaukee, Wisconsin, United States, 53226 |
Principal Investigator: | John E. Godwin, MD, MS | Simmons Cooper Cancer Institute |
Responsible Party: | University of Chicago Cancer Research Center ( Everett E. Vokes ) |
Study ID Numbers: | CDR0000462339, UCCRC-14194B, NCI-7071 |
Study First Received: | March 15, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00303966 History of Changes |
Health Authority: | United States: Food and Drug Administration |
refractory chronic lymphocytic leukemia stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia |
Lymphatic Diseases Leukemia Chronic Lymphocytic Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia, Lymphocytic, Chronic, B-Cell |
Leukemia, B-cell, Chronic Lymphoproliferative Disorders Leukemia, B-Cell Protein Kinase Inhibitors Sorafenib |
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Leukemia Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Leukemia, B-Cell Lymphoproliferative Disorders Sorafenib |