Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia

Phase 2

• Conditions: Leukemia; Lymphoma

• Registration Number: NCT01016990
• Lead Sponsor: Auxilio Mutuo Cancer Center

Brief 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.

Study Timeline

• Study Start: 2009-08
• Status Verified: 2009-11
• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Primary Completion: 2011-09
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to therapy (complete response, partial response, or stable disease)

Secondary Outcome Measures

Name	Time	Method
Length of response
Time to treatment failure
Survival duration

Trial Locations

Locations (1)

Centro de Cancer del Hospital Auxilio Mutuo; 🇵🇷 San Juan, Puerto Rico