Expired Study
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Indianapolis, Indiana 46202


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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000064947


NCT ID:

NCT00006340


Secondary ID:

BUMC-3756


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

3 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Boston Medical Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:December 1994
Completion Date:July 2000
Completion Type:Actual
Primary Completion Date:July 2000
Primary Completion Type:Actual
Verification Date:July 2013
Last Changed Date:July 25, 2013
First Received Date:October 4, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:arginine butyrate
Intervention Type:Drug
Name:ganciclovir

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Boston Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:9628848
Reference Type:Results Reference
Citation:Perrine SP, Hermine O, Small T, Suarez F, O'reilly R, Boulad F, Fingeroth J, Askin M, Levy A, Mentzer SJ, Dinicola M, Gianni AM, Klein C, Horwitz S, Faller DV. A phase I/II trial of arginine butyrate and ganciclovir in patients with Epstein-Barr virus-associated lymphoid malignancies. Blood. 2006 Nov 21; [Epub ahead of print]
PMID:17119113
Reference Type:Reference
Citation: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. Review.
PMID:11493400
Reference Type:Reference
Citation: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. Review.
PMID:11555713

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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