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Tracking Information | |||||
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First Received Date † | July 26, 2005 | ||||
Last Updated Date | May 23, 2008 | ||||
Start Date † | May 2005 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00124631 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Suberoylanilide Hydroxamic Acid in Treating Patients With Relapsed Non-Hodgkin's Lymphoma | ||||
Official Title † | A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL) | ||||
Brief Summary | RATIONALE: Suberoylanilide hydroxamic acid may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with relapsed B-cell non-Hodgkin's lymphoma. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is an open-label, multicenter study. Patients receive oral suberoylanilide hydroxamic acid twice daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed within 4 weeks and then every 6-12 months thereafter. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within approximately 1 year. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † | Lymphoma | ||||
Intervention † | Drug: vorinostat | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Estimated Enrollment † | 50 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00124631 | ||||
Responsible Party | |||||
Secondary IDs †† | UCLA-0411065-01, MERCK-013-00 | ||||
Study Sponsor † | Jonsson Comprehensive Cancer Center | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | January 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |