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

This study has been completed.
Sponsor:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00006340
First received: October 4, 2000
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Leukemia
Lymphoma
Precancerous Condition
Small Intestine Cancer
Drug: arginine butyrate
Drug: ganciclovir
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A PHASE I TRIAL OF BUTYRATE AND GANCICLOVIR IN EBV-ASSOCIATED MALIGNANCIES

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Study Start Date: December 1994
Study Completion Date: July 2000
Primary Completion Date: July 2000 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006340

Locations
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
France
Hopital Necker
Paris, France, 75743
Germany
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, Italy, 20133
Sponsors and Collaborators
Boston Medical Center
Investigators
Study Chair: Douglas V. Faller, MD, PhD Boston Medical Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006340     History of Changes
Other Study ID Numbers: CDR0000064947, BUMC-3756, BUSM-FDR001532, NCI-V00-1609
Study First Received: October 4, 2000
Last Updated: July 25, 2013
Health Authority: United States: Federal Government

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:
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Precancerous Conditions
Lymphoma, Large-Cell, Immunoblastic
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Ileal Diseases
Jejunal Diseases
Ganciclovir
Arginine butyrate
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014