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Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated With the Epstein Barr Virus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006340
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 26, 2013
Information provided by:
Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Precancerous Condition Small Intestine Cancer Drug: arginine butyrate Drug: ganciclovir Phase 1

Detailed Description:


  • Determine the safety, toxicity, and the reversibility of toxicity of arginine butyrate in patients with Epstein Barr virus-induced malignancies or lymphoproliferative disorders.
  • Determine the clinical pharmacology of arginine butyrate when administered with ganciclovir, including plasma half life and major routes of elimination in these patients.
  • Determine the biologic effects of arginine butyrate in terms of inducing sensitivity to ganciclovir in tissue samples from selected patients.
  • Determine the antitumor activity of this treatment regimen in these patients.

OUTLINE: Patients receive ganciclovir IV over 1 hour twice a day on days -1 to 21 for the first course (days 0-21 for all subsequent courses) and escalating doses of arginine butyrate IV continuously on days 0-21. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for a minimum of 42 days.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 2 years.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : December 1994
Actual Primary Completion Date : July 2000
Actual Study Completion Date : July 2000

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 3 and over

Performance status:

  • Any status


  • Absolute granulocyte count at least 1,000/mm^3
  • Platelet count at least 50,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • Aminotransferase less than 2 times normal


  • Creatinine less than 3.0 mg/dL
  • Creatinine clearance greater than 30 mL/min


  • No acute myocardial infarction within the past 6 months
  • No atrial fibrillation within the past 6 months


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Prior bone marrow or stem cell transplantation allowed
  • No concurrent immunotherapy
  • No concurrent interferon or tacrolimus


  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
  • No concurrent cytotoxic chemotherapy

Endocrine therapy:

  • No concurrent steroids


  • Recovered from prior radiotherapy


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006340

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United States, Indiana
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Hopital Necker
Paris, France, 75743
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, Italy, 20133
Sponsors and Collaborators
Boston Medical Center
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Study Chair: Douglas V. Faller, MD, PhD Boston Medical Center
Publications of Results:
Other Publications:
Layout table for additonal information Identifier: NCT00006340    
Other Study ID Numbers: CDR0000064947
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 26, 2013
Last Verified: July 2013
Keywords provided by Boston Medical Center:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
small intestine lymphoma
childhood immunoblastic large cell lymphoma
grade I lymphomatoid granulomatosis
grade II lymphomatoid granulomatosis
adult grade III lymphomatoid granulomatosis
recurrent adult grade III lymphomatoid granulomatosis
childhood grade III lymphomatoid granulomatosis
recurrent childhood grade III lymphomatoid granulomatosis
recurrent grade I lymphomatoid granulomatosis
recurrent grade II lymphomatoid granulomatosis
stage II childhood Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
Additional relevant MeSH terms:
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Precancerous Conditions
Intestinal Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Arginine butyrate
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents