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

This study has been terminated.
Sponsor:
Collaborator:
Boston University
Information provided by:
HemaQuest Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00917826
First received: June 8, 2009
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
EBV Lymphomas
Lympho-proliferative Diseases
Drug: Arginine Butyrate
Drug: Ganciclovir
Drug: Valganciclovir
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Low-Dose Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+)Lymphoid Malignancies

Resource links provided by NLM:


Further study details as provided by HemaQuest Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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.) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.) ] [ Designated as safety issue: No ]
  • 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.) ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: September 2008
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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)

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917826

Locations
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
HemaQuest Pharmaceuticals Inc.
Boston University
Investigators
Principal Investigator: Adam Lerner, M.D. Boston University School of Mediciine
  More Information

No publications provided

Responsible Party: Susan Perrine, M.D. Chief Scientific Officer, VP Clinical Affairs, HemaQuest Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00917826     History of Changes
Other Study ID Numbers: P2 L-D AB
Study First Received: June 8, 2009
Last Updated: July 28, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ganciclovir
Valganciclovir
Arginine butyrate
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014