Lymphoma Clinical Trial
Official title:
Histone Deacetylase (HDAC) Inhibition Using Vorinostat (SAHA) After Autologous Hematopoietic Stem Cell Transplantation for High Risk Lymphoma
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.
OBJECTIVES:
Primary
- To assess dose-limiting and nonhematologic toxicity of prolonged administration of
vorinostat (SAHA) when administered after autologous peripheral blood stem cell
transplantation in patients with high-risk lymphoma.
Secondary
- To determine, preliminarily, clinical activity by assessing the overall survival and
progression-free survival.
- To evaluate the effect of vorinostat on immune reconstruction and acetylation.
- To obtain pilot data regarding an association of vorinostat with patient quality of
life and inflammatory cytokine production of peripheral blood mononuclear cells.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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