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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00253630 |
RATIONALE: Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory indolent 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 Study Suberoylanilide Hydroxamic Acid (SAHA) in Indolent Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 33 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
OUTLINE: This is a multicenter study.
Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days for up to a total of 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 33 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 indolent non-Hodgkin's lymphoma, including the following subtypes:
Marginal zone B-cell lymphoma
Relapsed or refractory disease
No known brain metastases
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 4 prior chemotherapeutic regimens
Endocrine therapy
Radiotherapy
Other
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 |
Study Chair: | Mark H. Kirschbaum, MD | Beckman Research Institute |
Study ID Numbers: | CDR0000449981, CCC-PHII-63, NCI-6963 |
Study First Received: | November 11, 2005 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00253630 |
Health Authority: | United States: Federal Government |
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma splenic marginal zone lymphoma |
Immunoproliferative Disorders Lymphoma, Mantle-Cell Vorinostat Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, B-Cell, Marginal Zone Mantle cell lymphoma Recurrence |
Lymphoma, B-Cell Lymphatic Diseases B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
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 |