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

EBV Lymphomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00917826
• Other study ID #: P2 L-D AB
• Status: Terminated
• Phase: Phase 2
• First received: June 8, 2009
• Last updated: July 28, 2011
• Start date: September 2008

Study information

• Verified date: July 2011
• Source: HemaQuest Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• EBV Lymphomas
• Lympho-proliferative Diseases
• Lymphoproliferative Disorders

Intervention

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)
• Ganciclovir
5 mg/kg administered IV over 1 hour (Days 1-5 of each 21 day cycle)
• Valganciclovir
900 mg BID for 16 days (Days 6-21 of each 21 day cycle)

Locations

Country	Name	City	State
United States	Hackensack University Medical Center	Hackensack	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
HemaQuest Pharmaceuticals Inc.	Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	No
Secondary	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.)	No
Secondary	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.)	Yes