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

Primary Purpose

Lymphoid Malignancies, Lymphoproliferative Disorders

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HQK-1004
Valganciclovir (may substitute with ganciclovir)
Sponsored by
HemaQuest Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoid Malignancies

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LPCH/Stanford
  • University of California, San Francisco
  • Northwestern University Feinberg School of Medicine
  • Washington University School of Medicine
  • Hackensack University Medical Center
  • Weill Cornell Medical College
  • Abramson Cancer Center of the University of Pennsylvania
  • Feigin Center - Center for Cell and Gene Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HQK-1004 + Valganciclovir

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Safety and tolerability as measured by adverse events, physical exams, ECG, and laboratory evaluations
Overall and progression-free survival

Full Information

First Posted
October 7, 2009
Last Updated
July 28, 2011
Sponsor
HemaQuest Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00992732
Brief Title
Study of HQK-1004 and Valganciclovir to Treat Epstein-Barr Virus (EBV) - Positive Lymphoid Malignancies or Lymphoproliferative Disorders
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
HemaQuest Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoid Malignancies, Lymphoproliferative Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HQK-1004 + Valganciclovir
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HQK-1004
Other Intervention Name(s)
arginine butyrate
Intervention Description
1,000 mg/kg/day administered IV 24 hours/day for 5 days (Days 1-5 of each 21 day cycle)
Intervention Type
Drug
Intervention Name(s)
Valganciclovir (may substitute with ganciclovir)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
Days 21, 42, 84 and 126
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Berenson, MD
Organizational Affiliation
HemaQuest Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
LPCH/Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Feigin Center - Center for Cell and Gene Therapy
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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