A PHASE I TRIAL OF BUTYRATE AND GANCICLOVIR IN EBV-ASSOCIATED MALIGNANCIES
- Determine the safety, toxicity, and the reversibility of toxicity of arginine butyrate
in patients with Epstein Barr virus-induced malignancies or lymphoproliferative
- Determine the clinical pharmacology of arginine butyrate when administered with
ganciclovir, including plasma half life and major routes of elimination in these
- 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.
Primary Purpose: Treatment
Douglas V. Faller, MD, PhD
Boston Medical Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Methodist Cancer Center at Methodist Hospital||Indianapolis, Indiana 46202|
|Cancer Research Center at Boston Medical Center||Boston, Massachusetts 02118|