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

NCT00917826 | Terminated Phase 2

• 1 other identifier: P2 L-D AB
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

EBV Lymphomas; Lympho-proliferative Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.)

Study Arms (1)

Arginine Butyrate + Ganciclovir/Valganciclovir

EXPERIMENTAL

Drug: Arginine Butyrate; Drug: Ganciclovir; Drug: Valganciclovir

Interventions

Arginine Butyrate DRUG

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

Also known as: HQK-1004

Arginine Butyrate + Ganciclovir/Valganciclovir

Ganciclovir DRUG

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

Arginine Butyrate + Ganciclovir/Valganciclovir

Valganciclovir DRUG

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

Arginine Butyrate + Ganciclovir/Valganciclovir

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HemaQuest Pharmaceuticals Inc.: lead
• Boston University: collaborator

Study Sites (1)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Interventions

arginine butyrate; Ganciclovir; Valganciclovir

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Adam Lerner, M.D.

  Boston University School of Mediciine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Last Updated: August 1, 2011

Record last verified: 2011-07

Locations

US (1)