Back to results

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

Primary Purpose

EBV Lymphomas, Lympho-proliferative Diseases

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Arginine Butyrate

Ganciclovir

Valganciclovir

About this trial

This is an interventional treatment trial for EBV Lymphomas

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hackensack University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arginine Butyrate + Ganciclovir/Valganciclovir

Arm Description

Outcomes

Primary Outcome Measures

Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)

Secondary Outcome Measures

Progression Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)

Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam

Full Information

NCT ID

NCT00917826

First Posted

June 8, 2009

Last Updated

July 28, 2011

Sponsor

HemaQuest Pharmaceuticals Inc.

Collaborators

Boston University

1. Study Identification

Unique Protocol Identification Number

NCT00917826

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Terminated

Study Start Date

September 2008 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

HemaQuest Pharmaceuticals Inc.

Collaborators

Boston University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

EBV Lymphomas, Lympho-proliferative Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arginine Butyrate + Ganciclovir/Valganciclovir

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Arginine Butyrate

Other Intervention Name(s)

HQK-1004

Intervention Description

1,000 mg/kg/day administered IV over 24 hours/day for 5 days (Days 1-5 of each 21 day cycle)

Intervention Type

Drug

Intervention Name(s)

Ganciclovir

Intervention Description

5 mg/kg administered IV over 1 hour (Days 1-5 of each 21 day cycle)

Intervention Type

Drug

Intervention Name(s)

Valganciclovir

Intervention Description

900 mg BID for 16 days (Days 6-21 of each 21 day cycle)

Primary Outcome Measure Information:

Title

Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)

Time Frame

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 Measure Information:

Title

Progression Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)

Time Frame

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.)

Title

Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam

Time Frame

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.)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam Lerner, M.D.

Organizational Affiliation

Boston University School of Mediciine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hackensack University Medical Center

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs