Lymphoma Clinical Trial
Official title:
Epigenetic Therapy With Valproic Acid, an HDAC Inhibitor, in Refractory/Relapsed Non-Hodgkin Lymphoma, Hodgkin's Disease and CLL
RATIONALE: Valproic acid may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. It may also help cancer cells become more like normal cells, and
grow and spread more slowly.
PURPOSE: This phase II trial is studying how well valproic acid works in treating patients
with previously treated non-Hodgkin Lymphoma, Hodgkin lymphoma, or chronic lymphocytic
leukemia.
OBJECTIVES:
- To determine if valproic acid has a response rate of ≥ 20% in patients with previously
treated relapsed or refractory non-Hodgkin lymphoma, Hodgkin lymphoma, or chronic
lymphocytic leukemia.
- To determine if treatment with valproic acid leads to measurable levels of histone
acetylation in peripheral blood.
OUTLINE: Patients are stratified according to disease diagnosis (indolent non-Hodgkin
lymphoma [NHL] vs. aggressive NHL and Hodgkin lymphoma). Valproic acid doses are adjusted
until therapeutic level is achieved.
Patients receive oral valproic acid daily for 3 weeks. Treatment repeats every 3 weeks for
at least 2 courses and up to 2 years in the absence of disease progression or unacceptable
toxicity.
Blood samples are collected periodically. Samples are analyzed for valproic acid levels; and
hyperacetylation (caused by the valproic acid N-terminals of the histones H3 and H4) via
western blot.
;
Masking: Open Label, Primary Purpose: Treatment
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