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

January 9, 2014 updated by: Auxilio Mutuo Cancer Center

Epigenetic Therapy With Valproic Acid, an HDAC Inhibitor, in Refractory/Relapsed Non-Hodgkin Lymphoma, Hodgkin's Disease and CLL

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Puerto Rico
- - San Juan, Puerto Rico, 00936-2712
    - Recruiting
    - Centro de Cancer del Hospital Auxilio Mutuo
    - Contact:
      
      Contact Person
      
      Phone Number: 787-771-7933

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Diagnosis of relapsed or refractory Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL), or chronic lymphocytic leukemia (CLL )
Patient must have evaluable or measurable disease
Have failed prior treatment, as evidenced by 1 of the following:
- Aggressive NHL
  - Failed at least 1 regimen containing rituximab and CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) (unless anthracyclines are contraindicated) in addition to another salvage regimen (unless it is determined by the treating physician that it is to the patient's best interest to receive valproic acid after the first relapse)
- Hodgkin lymphoma
  - Failed ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and received salvage chemotherapy with at least 1 salvage combination regimen
- Indolent or low-grade lymphoma
  - Failed at least 1 combination regimen containing rituximab (patients who are intolerant to the available therapies or have contraindications for them are eligible for the study)
No CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Absolute granulocyte count ≥ 1,000/mm^3
Platelet count ≥ 50,000/µL
AST and ALT ≤ 3 times upper limit of normal
Creatinine ≤ 2.0 mg/dL
Bilirubin ≤ 1.5 mg/dL
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

More than 14 days since prior anticancer treatment
Prior high-dose chemotherapy with transplant allowed
No prior valproic acid
No concurrent corticosteroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response to therapy (complete response, partial response, or stable disease)

Secondary Outcome Measures

Outcome Measure
Time to treatment failure
Length of response
Survival duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auxilio Mutuo Cancer Center

Investigators

Principal Investigator: Fernando Cabanillas, MD, Auxilio Mutuo Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

November 19, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (Estimate)

November 20, 2009

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000659192
CCAM-HDACI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.