NCT01016990

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Last Updated

January 10, 2014

Status Verified

November 1, 2009

Enrollment Period

2.1 years

First QC Date

November 19, 2009

Last Update Submit

January 9, 2014

Conditions

LeukemiaLymphoma

Keywords

recurrent adult Hodgkin lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarefractory chronic lymphocytic leukemiarecurrent cutaneous T-cell non-Hodgkin lymphomaperipheral T-cell lymphomaAIDS-related peripheral/systemic lymphomaAIDS-related diffuse large cell lymphomaAIDS-related immunoblastic large cell lymphomaAIDS-related small noncleaved cell lymphomaAIDS-related diffuse mixed cell lymphomaAIDS-related diffuse small cleaved cell lymphomaAIDS-related lymphoblastic lymphomaWaldenström macroglobulinemia

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

  • Length of response

  • Time to treatment failure

  • Survival duration

Interventions

valproic acidDRUG
western blottingGENETIC
laboratory biomarker analysisOTHER
pharmacological studyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centro de Cancer del Hospital Auxilio Mutuo

San Juan, 00936-2712, Puerto Rico

RECRUITING

MeSH Terms

Conditions

LeukemiaLymphomaHodgkin DiseaseBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellLymphoma, T-Cell, CutaneousLymphoma, T-Cell, PeripheralWaldenstrom Macroglobulinemia

Interventions

Valproic AcidBlotting, Western

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, T-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipidsElectrophoresisChemistry Techniques, AnalyticalInvestigative TechniquesElectrochemical TechniquesImmunoblottingImmunoassayImmunologic TechniquesMolecular Probe Techniques

Study Officials

  • Fernando Cabanillas, MD

    Auxilio Mutuo Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 20, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2011

Last Updated

January 10, 2014

Record last verified: 2009-11

Locations

PR(1)