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Clinical Trials (PDQ®)

Phase II Study of Valproic Acid in Patients With Previously Treated Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentUnknownOver 18OtherCCAM-HDACI
Epigenetic Therapy with Valproic Acid, an HDAC Inh, NCT01016990

Objectives

  1. 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.
  1. To determine if treatment with valproic acid leads to measurable levels of histone acetylation in peripheral blood.

Entry 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

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

Patient Characteristics:

  • ECOG performance status 0-2
  • Absolute granulocyte count ≥ 1,000/mm3
  • 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

Expected Enrollment

52

Outcomes

Primary Outcome(s)

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

Secondary Outcome(s)

Length of response
Time to treatment failure
Survival duration

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.

Trial Contact Information

Trial Lead Organizations

Centro de Cancer del Hospital Auxilio Mutuo

Fernando Cabanillas, MD, Principal investigator
Ph: 787-771-7933

Registry Information
Official Title Epigenetic Therapy with Valproic Acid, an HDAC Inhibitor, in Refractory/Relapsed Non-Hodgkin Lymphoma, Hodgkin’s Disease and CLL
Trial Start Date 2009-08-30
Trial Completion Date 2011-09-15 (estimated)
Registered in ClinicalTrials.gov NCT01016990
Date Submitted to PDQ 2009-11-09
Information Last Verified 2009-11-18

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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