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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00124631 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: vorinostat |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL) |
Estimated Enrollment: | 50 |
Study Start Date: | May 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diffuse large B-cell lymphoma
Relapsed disease, defined as recurrent or progressive disease after standard first-line chemotherapy (e.g., CHOP or an anthracycline-containing regimen equivalent) AND 1 systemic salvage therapy that may have included autologous stem cell transplantation
Failed no more than 3 prior treatment regimens
No active brain or leptomeningeal metastases, as indicated by positive cytology from lumbar puncture or CT scan or MRI
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095 |
Study Chair: | Sven De Vos, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000437056, UCLA-0411065-01, MERCK-013-00 |
Study First Received: | July 26, 2005 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00124631 |
Health Authority: | United States: Federal Government |
recurrent adult diffuse large cell lymphoma |
Lymphoma, large-cell Lymphoma, B-Cell Lymphatic Diseases Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders B-cell lymphomas |
Vorinostat Lymphoma, small cleaved-cell, diffuse Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Recurrence |
Anticarcinogenic Agents Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protective Agents Pharmacologic Actions |
Neoplasms Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |