Lymphoma Clinical Trial
Official title:
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.
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.
;
Primary Purpose: Treatment
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