Epigenetic Therapy With Valproic Acid, an HDAC Inhibitor, in Refractory/Relapsed Non-Hodgkin Lymphoma, Hodgkin's Disease and CLL
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Response to therapy (complete response, partial response, or stable disease)
No
Fernando Cabanillas, MD
Principal Investigator
Auxilio Mutuo Cancer Center
Unspecified
CDR0000659192
NCT01016990
August 2009
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