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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00131937 |
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 tumor.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with recurrent diffuse large B-cell non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 41 |
Study Start Date: | October 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 13-41 patients will be accrued for this study within 4-14 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed de novo or transformed diffuse large B-cell non-Hodgkin's lymphoma (NHL) OR one of the following variants, according to the WHO classification system
Recurrent disease
Must have failed ≥ 1 prior chemotherapy or antibody therapy regimen for NHL with curative intent
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following:
Investigator: | Sandra J. Horning, MD | Stanford University |
Study Chair: | Daniel R. Greenwald, MD | Stanford University |
Study ID Numbers: | CDR0000437860, ECOG-E1404 |
Study First Received: | August 16, 2005 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00131937 |
Health Authority: | United States: Federal Government |
recurrent adult diffuse large cell lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Lymphoma, small cleaved-cell, diffuse Recurrence Lymphoma, B-Cell Lymphoma, large-cell Lymphatic Diseases |
B-cell lymphomas Lymphoma, Non-Hodgkin Aggression Lymphoproliferative Disorders Lymphoma Sorafenib |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |