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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lymphoproliferative Disorders; Lymphoid Malignancies
• Intervention / Treatment: Drug: HQK-1004; Drug: Valganciclovir (may substitute with ganciclovir)

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • LPCH/Stanford
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania
  • Texas
    • Houston, Texas, United States, 77030
      • Feigin Center - Center for Cell and Gene Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall response rate	Days 21, 42, 84 and 126

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HemaQuest Pharmaceuticals Inc.
• Investigators: Study Director: Ron Berenson, MD, HemaQuest Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: October 7, 2009
• First Submitted That Met QC Criteria: October 8, 2009
• First Posted (Estimate): October 9, 2009

Study Record Updates

• Last Update Posted (Estimate): August 1, 2011
• Last Update Submitted That Met QC Criteria: July 28, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Immune System Diseases; Lymphatic Diseases; Immunoproliferative Disorders; DNA Virus Infections; Tumor Virus Infections; Herpesviridae Infections; Neoplasms; Epstein-Barr Virus Infections; Lymphoproliferative Disorders; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Valganciclovir; Ganciclovir; Ganciclovir triphosphate; Arginine butyrate
• Other Study ID Numbers: HQP-1004-EB-03