Trials / Unknown
UnknownNCT01016990
Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia
Epigenetic Therapy With Valproic Acid, an HDAC Inhibitor, in Refractory/Relapsed Non-Hodgkin Lymphoma, Hodgkin's Disease and CLL
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- Sponsor
- Auxilio Mutuo Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | valproic acid | |
| GENETIC | western blotting | |
| OTHER | laboratory biomarker analysis | |
| OTHER | pharmacological study |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2011-09-01
- First posted
- 2009-11-20
- Last updated
- 2014-01-10
Locations
1 site across 1 country: Puerto Rico
Source: ClinicalTrials.gov record NCT01016990. Inclusion in this directory is not an endorsement.