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Study of HQK-1004 and Valganciclovir to Treat Epstein-Barr Virus (EBV) - Positive Lymphoid Malignancies or Lymphoproliferative Disorders

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00992732
First Posted: October 9, 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.
Information provided by:
HemaQuest Pharmaceuticals Inc.
  Purpose
The purpose of this study is to determine if treatment with HQK-1004 and valganciclovir will result in complete or partial responses in patients with EBV-positive lymphoid malignancies or lymphoproliferative disorders.

Condition Intervention Phase
Lymphoid Malignancies Lymphoproliferative Disorders Drug: HQK-1004 Drug: Valganciclovir (may substitute with ganciclovir) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a Open-Label Multi-Center Study Evaluating HQK-1004 Administered With Valganciclovir in Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Lymphoid Malignancies or Lymphoproliferative Disorders

Resource links provided by NLM:


Further study details as provided by HemaQuest Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Days 21, 42, 84 and 126 ]

Secondary Outcome Measures:
  • Safety and tolerability as measured by adverse events, physical exams, ECG, and laboratory evaluations [ Time Frame: through end of treatment (up to Day 126) and 30 days post last dose ]
  • Overall and progression-free survival [ Time Frame: through end of treatment (up to Day 126), then every 8 weeks for 1 year post last dose ]

Enrollment: 1
Study Start Date: May 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HQK-1004 + Valganciclovir Drug: HQK-1004
1,000 mg/kg/day administered IV 24 hours/day for 5 days (Days 1-5 of each 21 day cycle)
Other Name: arginine butyrate
Drug: Valganciclovir (may substitute with ganciclovir)
900 mg BID oral for 21 days (Days 1-21 of each 21 day cycle). If the subject cannot tolerate or absorb valganciclovir, ganciclovir my be administered instead at 5 mg/kg intravenously BID until the subject can tolerate and absorb valganciclovir.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed lymphoid malignancy or lymphoproliferative disorder with EBV detected by either immunohistochemistry or in situ hybridization. Pathology can be assessed on either a current or previous biopsy. All disease stages are eligible
  • Disease that is refractory or relapsed after at least one prior standard therapeutic regimen, which includes biologic agents (e.g., monoclonal antibodies), chemotherapy or chemoradiotherapy regimens. Prior therapy may include high dose chemotherapy and stem cell rescue or bone marrow transplantation
  • Bidimensionally measurable disease by computerized tomography (CT) or magnetic resonance imaging (MRI; patients with sensitivity to contrast or for tumor types that are less accurately measured by CT) scan or physical measurement (cutaneous lesions only) with at least 1 lesion ≥ 10 mm in the greatest diameter. PET-CT should be used at baseline for patients with Hodgkin's Disease (HD) or diffuse large B-cell lymphoma (DLBCL).
  • Absolute neutrophil count ≥ 500/mm3 and platelet count ≥ 50,000/mm3
  • Bilirubin ≤ 2.0 times upper limit of normal (ULN) with the exception of patients with Gilbert's syndrome (bilirubin ≤ 3.5 times ULN allowed), and both AST and ALT ≤ 3 times ULN
  • Serum creatinine ≤ 2.0 mg/dL

Exclusion Criteria:

  • Patients who have not recovered from previous treatment with chemotherapy
  • Patients who have been treated with biologic agents within two weeks prior to first dose of HQK-1004
  • Uncontrolled ischemic heart disease or uncontrolled congestive heart failure, or myocardial infarction within the past 3 months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992732


Locations
United States, California
LPCH/Stanford
Palo Alto, California, United States, 94304
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Feigin Center - Center for Cell and Gene Therapy
Houston, Texas, United States, 77030
Sponsors and Collaborators
HemaQuest Pharmaceuticals Inc.
Investigators
Study Director: Ron Berenson, MD HemaQuest Pharmaceuticals Inc.
  More Information

Responsible Party: Patrick Bobbitt, Vice President, Development, HemaQuest Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00992732     History of Changes
Other Study ID Numbers: HQP-1004-EB-03
First Submitted: October 7, 2009
First Posted: October 9, 2009
Last Update Posted: August 1, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Neoplasms
Arginine butyrate
Disease
Lymphoproliferative Disorders
Pathologic Processes
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ganciclovir
Valganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents