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

Primary Purpose

Leukemia, Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Puerto Rico
Study Type
Interventional
Intervention
valproic acid
western blotting
laboratory biomarker analysis
pharmacological study
Sponsored by
Auxilio Mutuo Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro de Cancer del Hospital Auxilio MutuoRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of response
Time to treatment failure
Survival duration

Full Information

First Posted
November 19, 2009
Last Updated
January 9, 2014
Sponsor
Auxilio Mutuo Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01016990
Brief Title
Valproic Acid in Treating Patients With Previously Treated Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Chronic Lymphocytic Leukemia
Official Title
Epigenetic Therapy With Valproic Acid, an HDAC Inhibitor, in Refractory/Relapsed Non-Hodgkin Lymphoma, Hodgkin's Disease and CLL
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Auxilio Mutuo Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
valproic acid
Intervention Type
Genetic
Intervention Name(s)
western blotting
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
pharmacological study
Primary Outcome Measure Information:
Title
Response to therapy (complete response, partial response, or stable disease)
Secondary Outcome Measure Information:
Title
Length of response
Title
Time to treatment failure
Title
Survival duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Cabanillas, MD
Organizational Affiliation
Auxilio Mutuo Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Cancer del Hospital Auxilio Mutuo
City
San Juan
ZIP/Postal Code
00936-2712
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
787-771-7933

12. IPD Sharing Statement

Learn more about this trial

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

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