NCT00006340

Brief Summary

RATIONALE: The Epstein Barr virus can cause cancer and lymphoproliferative disorders. Ganciclovir is an antiviral drug that acts against the Epstein Barr virus. Arginine butyrate may make virus cells more sensitive to ganciclovir. Combining ganciclovir and arginine butyrate may kill more Epstein Barr virus cells and tumor cells. PURPOSE: Phase I trial to study the effectiveness of arginine butyrate plus ganciclovir in treating patients who have cancer or lymphoproliferative disorders that are associated with the Epstein Barr virus.

Trial Health

90
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 1994

Typical duration for phase_1 leukemia

Geographic Reach
4 countries

6 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1994

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

July 26, 2013

Status Verified

July 1, 2013

Enrollment Period

5.6 years

First QC Date

October 4, 2000

Last Update Submit

July 25, 2013

Conditions

LeukemiaLymphomaPrecancerous ConditionSmall Intestine Cancer

Keywords

stage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomastage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomastage I childhood lymphoblastic lymphomastage II childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent childhood lymphoblastic lymphomasmall intestine lymphomachildhood immunoblastic large cell lymphomagrade I lymphomatoid granulomatosisgrade II lymphomatoid granulomatosisadult grade III lymphomatoid granulomatosisrecurrent adult grade III lymphomatoid granulomatosischildhood grade III lymphomatoid granulomatosisrecurrent childhood grade III lymphomatoid granulomatosisrecurrent grade I lymphomatoid granulomatosisrecurrent grade II lymphomatoid granulomatosisstage II childhood Hodgkin lymphomastage I childhood Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I adult diffuse small cleaved cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse large cell lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I adult Burkitt lymphomaT-cell large granular lymphocyte leukemiastage II grade 1 follicular lymphomastage II grade 2 follicular lymphomastage II grade 3 follicular lymphomastage II adult diffuse small cleaved cell lymphomastage II adult diffuse mixed cell lymphomastage II adult diffuse large cell lymphomastage II adult immunoblastic large cell lymphomastage II adult lymphoblastic lymphomastage II adult Burkitt lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomastage I childhood small noncleaved cell lymphomastage I childhood large cell lymphomastage II childhood small noncleaved cell lymphomastage II childhood large cell lymphomastage III childhood small noncleaved cell lymphomastage III childhood large cell lymphomastage IV childhood small noncleaved cell lymphomastage IV childhood large cell lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomastage I mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomastage II mantle cell lymphomastage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomastage II small lymphocytic lymphomastage II marginal zone lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

arginine butyrateDRUG
ganciclovirDRUG

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed malignancy or lymphoproliferative disease including the following: * Nasopharyngeal carcinoma * Hodgkin's lymphoma * African Burkitt's lymphoma * T-cell non-Hodgkin's lymphoma * B-cell non-Hodgkin's lymphoma if Epstein Barr Virus (EBV) positive * Other lymphomas associated with immunodeficiency or immunosuppression, including AIDS-related lymphoma * B-cell lymphoproliferative disorders * Monoclonal or oligoclonal B-cell lymphoid disease (no polyclonal disease) * EBV positive by immunohistochemistry or in situ hybridization * Negative serology for EBV allowed PATIENT CHARACTERISTICS: Age: * 3 and over Performance status: * Any status Hematopoietic: * Absolute granulocyte count at least 1,000/mm\^3 * Platelet count at least 50,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * Aminotransferase less than 2 times normal Renal: * Creatinine less than 3.0 mg/dL * Creatinine clearance greater than 30 mL/min Cardiovascular: * No acute myocardial infarction within the past 6 months * No atrial fibrillation within the past 6 months Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior bone marrow or stem cell transplantation allowed * No concurrent immunotherapy * No concurrent interferon or tacrolimus Chemotherapy: * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered * No concurrent cytotoxic chemotherapy Endocrine therapy: * No concurrent steroids Radiotherapy: * Recovered from prior radiotherapy Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (6)

Methodist Cancer Center at Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Hopital Necker

Paris, 75743, France

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milan, 20133, Italy

Location

Related Publications (4)

  • Faller DV, Mentzer SJ, Perrine SP. Induction of the Epstein-Barr virus thymidine kinase gene with concomitant nucleoside antivirals as a therapeutic strategy for Epstein-Barr virus-associated malignancies. Curr Opin Oncol. 2001 Sep;13(5):360-7. doi: 10.1097/00001622-200109000-00008.

    PMID: 11555713BACKGROUND

  • Mentzer SJ, Perrine SP, Faller DV. Epstein--Barr virus post-transplant lymphoproliferative disease and virus-specific therapy: pharmacological re-activation of viral target genes with arginine butyrate. Transpl Infect Dis. 2001 Sep;3(3):177-85. doi: 10.1034/j.1399-3062.2001.003003177.x.

    PMID: 11493400BACKGROUND

  • Perrine SP, Hermine O, Small T, Suarez F, O'Reilly R, Boulad F, Fingeroth J, Askin M, Levy A, Mentzer SJ, Di Nicola M, Gianni AM, Klein C, Horwitz S, Faller DV. A phase 1/2 trial of arginine butyrate and ganciclovir in patients with Epstein-Barr virus-associated lymphoid malignancies. Blood. 2007 Mar 15;109(6):2571-8. doi: 10.1182/blood-2006-01-024703. Epub 2006 Nov 21.

    PMID: 17119113RESULT

  • Mentzer SJ, Fingeroth J, Reilly JJ, Perrine SP, Faller DV. Arginine butyrate-induced susceptibility to ganciclovir in an Epstein-Barr-virus-associated lymphoma. Blood Cells Mol Dis. 1998 Jun;24(2):114-23. doi: 10.1006/bcmd.1998.0178.

    PMID: 9628848RESULT

MeSH Terms

Conditions

LeukemiaLymphomaPrecancerous ConditionsHodgkin DiseaseLymphoma, T-Cell, CutaneousRecurrenceLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLeukemia, Large Granular LymphocyticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

arginine butyrateGanciclovir

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellLeukemia, LymphoidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, T-CellHistiocytic Disorders, MalignantHistiocytosisLymphadenopathyLeukemia, B-CellChronic Disease

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Douglas V. Faller, MD, PhD

    Boston Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2000

First Posted

January 27, 2003

Study Start

December 1, 1994

Primary Completion

July 1, 2000

Study Completion

July 1, 2000

Last Updated

July 26, 2013

Record last verified: 2013-07

Locations

DE(1)IT(1)US(3)FR(1)