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

Phase 1

Completed

• Conditions: Leukemia; Lymphoma; Precancerous Condition; Small Intestine Cancer

• Registration Number: NCT00006340
• Lead Sponsor: Boston Medical Center

Brief 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.

Study Timeline

• Study Start: 1994-12
• Primary Completion: 2000-07
• Study Completion: 2000-07
• Study First Submitted: 2000-10-04
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-25
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Cancer Research Center at Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Istituto Nazionale per lo Studio e la Cura dei Tumori; 🇮🇹 Milan, Italy

Hopital Necker; 🇫🇷 Paris, France

Methodist Cancer Center at Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States