Trial record 2 of 81 for:    cancer | butyrate

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Arginine butyrate
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ganciclovir
Valganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014