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| Sponsor: | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| 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 Genetic: DNA analysis Other: immunohistochemistry staining method Other: immunologic technique Other: laboratory biomarker analysis |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label |
| Official Title: | Histone Deacetylase (HDAC) Inhibition Using Vorinostat (SAHA) After Autologous Hematopoietic Stem Cell Transplantation for High Risk Lymphoma |
| Estimated Enrollment: | 24 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | November 2009 (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 | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210-1240 | |
| Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
| Study Chair: | Craig C. Hofmeister, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
More Information
| Study ID Numbers: | CDR0000575701, OSU-07047, MERCK-OSU-07047, OSU-2007C0077 |
| Study First Received: | November 20, 2007 |
| Last Updated: | March 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00561418 History of Changes |
| Health Authority: | Unspecified |
|
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 |
|
Anticarcinogenic Agents Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Ileal Diseases Duodenal Neoplasms Neoplasms by Site Ileal Neoplasms Jejunal Diseases Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Lymphoma Duodenal Diseases Jejunal Neoplasms Digestive System Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Vorinostat Enzyme Inhibitors Intestinal Diseases Protective Agents Pharmacologic Actions Intestinal Neoplasms Lymphatic Diseases Neoplasms |