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

NCT ID: NCT00917826

Last Updated: 2011-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arginine Butyrate + Ganciclovir/Valganciclovir

Group Type: EXPERIMENTAL

Arginine Butyrate

Intervention Type: DRUG

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

Ganciclovir

Intervention Type: DRUG

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

Valganciclovir

Intervention Type: DRUG

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

Interventions

Arginine Butyrate

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

Ganciclovir

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

Intervention Type: DRUG

Valganciclovir

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

Intervention Type: DRUG

Other Intervention Names

HQK-1004

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.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: collaborator

HemaQuest Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

HemaQuest Pharmaceuticals Inc.

Principal Investigators

Adam Lerner, M.D.

Role: PRINCIPAL_INVESTIGATOR

Boston University School of Mediciine

Locations

Hackensack University Medical Center

Hackensack, New Jersey, United States

Countries

United States

Other Identifiers

P2 L-D AB

Identifier Type: -

Identifier Source: org_study_id