Clinical Trials Directory

Trials / Completed

CompletedNCT00006340

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

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
—
Sponsor
Boston Medical Center · Academic / Other
Sex
All
Age
3 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGarginine butyrate
DRUGganciclovir

Timeline

Start date
1994-12-01
Primary completion
2000-07-01
Completion
2000-07-01
First posted
2003-01-27
Last updated
2013-07-26

Locations

6 sites across 4 countries: United States, France, Germany, Italy

Source: ClinicalTrials.gov record NCT00006340. Inclusion in this directory is not an endorsement.