Study of Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+) Lymphoid Malignancies

A Phase II Trial of Low-Dose Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+)Lymphoid Malignancies

The purpose of this study is to assess whether administration of Arginine Butyrate + ganciclovir/valganciclovir for up to three 21-day cycles is tolerable, and results in partial or complete responses in patients with EBV(+) lymphoid malignancies.

Study Overview

• Status: Terminated
• Conditions: EBV Lymphomas; Lympho-proliferative Diseases
• Intervention / Treatment: Drug: Arginine Butyrate; Drug: Ganciclovir; Drug: Valganciclovir

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 3 years. (No dosing or adverse event data are currently available on the use of valganciclovir in patients < 16 years of age.)
• Life expectancy of > 3 months.
• ECOG Performance Status 0-2 or Karnofsky Performance Scale ≥ 60%.
• Baseline (untransfused) HbF level > 2%
• Normal organ and marrow function defined as: (i) absolute neutrophil count of ≥ 1,000/µL. (ii) platelets ≥ 50,000/ µL. (iii) total bilirubin of ≤ 2.0 x upper limit of normal. (iv) AST (SGOT)/ALT(SGPT) of ≤ 2.0 x institutional upper limit of normal. (v) creatinine within normal range for institution.
• Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
• Able and willing to give informed consent.

Exclusion Criteria:

• Patients that have received chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entry, or those who have not recovered form adverse events due to agents administered 4 weeks earlier.
• Patients may not be receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Arginine Butyrate, ganciclovir or valganciclovir.
• Patients who have an acute myocardial infarction or onset of atrial fibrillation within the past 6 months.
• Uncontrolled intercurrent illness including, but not limited to , ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Tumor impinging on an organ or anatomical structure deemed critical by the investigator.
• Pregnant women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arginine Butyrate + Ganciclovir/Valganciclovir	Drug: Arginine Butyrate; 1,000 mg/kg/day administered IV over 24 hours/day for 5 days (Days 1-5 of each 21 day cycle); Other Names: HQK-1004; Drug: Ganciclovir; 5 mg/kg administered IV over 1 hour (Days 1-5 of each 21 day cycle); Drug: Valganciclovir; 900 mg BID for 16 days (Days 6-21 of each 21 day cycle)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)	Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.)

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)	Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.)
Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam	Up to three 21-day cycles. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessments may continue after treatment is discontinued.)

Collaborators and Investigators

• Sponsor: HemaQuest Pharmaceuticals Inc.
• Collaborators: Boston University
• Investigators: Principal Investigator: Adam Lerner, M.D., Boston University School of Mediciine

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: June 8, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (Estimate): June 10, 2009

Study Record Updates

• Last Update Posted (Estimate): August 1, 2011
• Last Update Submitted That Met QC Criteria: July 28, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoproliferative Disorders; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Valganciclovir; Ganciclovir; Ganciclovir triphosphate; Arginine butyrate
• Other Study ID Numbers: P2 L-D AB