Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT01016990|
Recruitment Status : Unknown
Verified November 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : November 20, 2009
Last Update Posted : January 10, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Drug: valproic acid Genetic: western blotting Other: laboratory biomarker analysis Other: pharmacological study||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Masking:||None (Open Label)|
|Official Title:||Epigenetic Therapy With Valproic Acid, an HDAC Inhibitor, in Refractory/Relapsed Non-Hodgkin Lymphoma, Hodgkin's Disease and CLL|
|Study Start Date :||August 2009|
|Estimated Primary Completion Date :||September 2011|
- Response to therapy (complete response, partial response, or stable disease)
- Length of response
- Time to treatment failure
- Survival duration
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016990
|Centro de Cancer del Hospital Auxilio Mutuo||Recruiting|
|San Juan, Puerto Rico, 00936-2712|
|Contact: Contact Person 787-771-7933|
|Principal Investigator:||Fernando Cabanillas, MD||Auxilio Mutuo Cancer Center|