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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01016990
First received: November 19, 2009
Last updated: January 9, 2014
Last verified: November 2009
  Purpose

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 Intervention Phase
Leukemia
Lymphoma
Drug: valproic acid
Genetic: western blotting
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response to therapy (complete response, partial response, or stable disease) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Survival duration [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: August 2009
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016990

Locations
Puerto Rico
Centro de Cancer del Hospital Auxilio Mutuo Recruiting
San Juan, Puerto Rico, 00936-2712
Contact: Contact Person    787-771-7933      
Sponsors and Collaborators
Auxilio Mutuo Cancer Center
Investigators
Principal Investigator: Fernando Cabanillas, MD Auxilio Mutuo Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01016990     History of Changes
Other Study ID Numbers: CDR0000659192, CCAM-HDACI
Study First Received: November 19, 2009
Last Updated: January 9, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
refractory chronic lymphocytic leukemia
recurrent cutaneous T-cell non-Hodgkin lymphoma
peripheral T-cell lymphoma
AIDS-related peripheral/systemic lymphoma
AIDS-related diffuse large cell lymphoma
AIDS-related immunoblastic large cell lymphoma
AIDS-related small noncleaved cell lymphoma
AIDS-related diffuse mixed cell lymphoma
AIDS-related diffuse small cleaved cell lymphoma
AIDS-related lymphoblastic lymphoma
Waldenström macroglobulinemia

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 14, 2014