Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia
Recruitment status was: Recruiting
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.
Drug: valproic acid
Genetic: western blotting
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Epigenetic Therapy With Valproic Acid, an HDAC Inhibitor, in Refractory/Relapsed Non-Hodgkin Lymphoma, Hodgkin's Disease and CLL|
- Response to therapy (complete response, partial response, or stable disease) [ Designated as safety issue: No ]
- Length of response [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Survival duration [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016990
|Centro de Cancer del Hospital Auxilio Mutuo|
|San Juan, Puerto Rico, 00936-2712|
|Principal Investigator:||Fernando Cabanillas, MD||Auxilio Mutuo Cancer Center|