Finding studies
Finding studies
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Lead
Ohio State University Comprehensive Cancer Center
With
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
