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| Sponsor: | Ohio State University Comprehensive Cancer Center |
|---|---|
| Collaborator: |
Merck |
| Information provided by (Responsible Party): | Ohio State University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00561418 |
Purpose
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth, and may stimulate the immune system to stop cancer cells from growing.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat after stem cell transplant in treating patients with high-risk lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Small Intestine Cancer |
Drug: vorinostat Other: Correlative studies |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Histone Deacetylase (HDAC) Inhibition Using Vorinostat (SAHA) After Autologous Hematopoietic Stem Cell Transplantation for High Risk Lymphoma |
| Enrollment: | 23 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of vorinostat (SAHA).
Approximately 60 days after autologous hematopoietic stem cell transplantation (HSCT), patients receive oral vorinostat once daily on days 1-21. Treatment repeats every 28 days for up to 11 courses in the absence of unacceptable toxicity or disease progression.
Blood and bone marrow samples are collected periodically for laboratory correlative studies comprising immune reconstitution assays, regulatory T-cell expansion analysis, H3 and H4 acetylation by immunohistochemistry, cytokine bead array to quantify interleukin (IL)-2, IL-4, IL-5, IL-6, IL-10, tumor necrosis factor alpha and interferon gamma. Quality of life correlative studies are measured by questionnaires periodically.
After completion of study treatment, patients are followed for at least 30 days.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have received a BEAM (cytarabine, etoposide, melphalan, carmustine)-conditioned autologous stem cell transplantation for any of the following high-risk lymphomas:
Diffuse large B-cell lymphoma as defined by:
Follicular lymphoma as defined by:
Hodgkin lymphoma as defined by:
Mantle cell lymphoma
T-cell non-Hodgkin lymphoma (NHL)
Peripheral T-cell lymphoma not otherwise specified and one or more of the following at diagnosis:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent radiotherapy, unless for local control of bone pain
Contacts and Locations| United States, Ohio | |
| Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| Principal Investigator: | Craig C. Hofmeister, MD | Ohio State University Comprehensive Cancer Center |
More Information
| Responsible Party: | Ohio State University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00561418 History of Changes |
| Other Study ID Numbers: | OSU-07047, NCI-2011-03145 |
| Study First Received: | November 20, 2007 |
| Last Updated: | February 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
recurrent adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma recurrent grade 3 follicular lymphoma recurrent adult Hodgkin lymphoma recurrent mantle cell lymphoma adult nasal type extranodal NK/T-cell lymphoma |
angioimmunoblastic T-cell lymphoma recurrent adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma small intestine lymphoma anaplastic large cell lymphoma |
|
Lymphoma Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Intestinal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Ileal Diseases Jejunal Diseases Vorinostat Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |