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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303953 |
RATIONALE: PXD101 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 PXD101 works in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
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Lymphoma |
Drug: belinostat |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas |
Estimated Enrollment: | 40 |
Study Start Date: | January 2006 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study.
Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Needle core biopsies and peripheral blood mononuclear cells are obtained from the first 20 patients pre- and post-treatment for biomarker correlative studies.
After completion of study treatment, patients are followed every 3-6 months for up to 3 years.
PROJECTED ACCRUAL: A total of 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:
Biopsy-proven* aggressive B-cell non-Hodgkin's lymphoma (NHL), including 1 of the following histology subtypes:
PATIENT CHARACTERISTICS:
No other significant cardiovascular disease, including any of the following:
No clinical evidence of any of the following:
PRIOR CONCURRENT THERAPY:
No more than 5 prior chemotherapy regimens
Study Chair: | Steven H. Bernstein, MD | James P. Wilmot Cancer Center |
Investigator: | Thomas P. Miller, MD | University of Arizona |
Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
Study ID Numbers: | CDR0000462614, SWOG-S0520 |
Study First Received: | March 15, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00303953 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent adult diffuse large cell lymphoma recurrent adult Burkitt lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Recurrence Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Burkitt's Lymphoma Lymphatic Diseases |
B-cell Lymphomas Burkitt Lymphoma Lymphoma, Non-Hodgkin Aggression Lymphoproliferative Disorders Lymphoma, Large-cell Lymphoma |
Lymphoma, B-Cell Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |