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

July 25, 2013 updated by: Boston Medical Center

A PHASE I TRIAL OF BUTYRATE AND GANCICLOVIR IN EBV-ASSOCIATED MALIGNANCIES

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75743
        • Hôpital Necker
  • Germany
      • Hannover, Germany, D-30625
        • Medizinische Hochschule Hannover
  • Italy
      • Milan, Italy, 20133
        • Istituto Nazionale Per Lo Studio E La Cura Dei Tumori
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Methodist Cancer Center at Methodist Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Cancer Research Center at Boston Medical Center
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Investigators

  • Study Chair: Douglas V. Faller, MD, PhD, Boston Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1994

Primary Completion (ACTUAL)

July 1, 2000

Study Completion (ACTUAL)

July 1, 2000

Study Registration Dates

First Submitted

October 4, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2013

Last Update Submitted That Met QC Criteria

July 25, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000064947
  • BUMC-3756
  • BUSM-FDR001532
  • NCI-V00-1609

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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