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

This study has been terminated.
Sponsor:
Information provided by:
HemaQuest Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00992732
First received: October 7, 2009
Last updated: July 28, 2011
Last verified: July 2011
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: October 7, 2009
Last Updated: July 28, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Lymphoproliferative Disorders
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 August 19, 2014