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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00917826
First Posted: June 10, 2009
Last Update Posted: August 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boston University
Information provided by:
HemaQuest Pharmaceuticals Inc.
June 8, 2009
June 10, 2009
August 1, 2011
September 2008
September 2009   (Final data collection date for primary outcome measure)
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.) ]
Same as current
Complete list of historical versions of study NCT00917826 on ClinicalTrials.gov Archive Site
  • 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.) ]
  • 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.) ]
Same as current
Not Provided
Not Provided
 
Study of Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+) Lymphoid Malignancies
A Phase II Trial of Low-Dose Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+)Lymphoid Malignancies
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • EBV Lymphomas
  • Lympho-proliferative Diseases
  • 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)
Experimental: Arginine Butyrate + Ganciclovir/Valganciclovir
Interventions:
  • Drug: Arginine Butyrate
  • Drug: Ganciclovir
  • Drug: Valganciclovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
Not Provided
September 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
3 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00917826
P2 L-D AB
No
Not Provided
Not Provided
Susan Perrine, M.D. Chief Scientific Officer, VP Clinical Affairs, HemaQuest Pharmaceuticals Inc.
HemaQuest Pharmaceuticals Inc.
Boston University
Principal Investigator: Adam Lerner, M.D. Boston University School of Mediciine
HemaQuest Pharmaceuticals Inc.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP