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

Lymphoproliferative Disorders Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00992732
• Other study ID #: HQP-1004-EB-03
• Status: Terminated
• Phase: Phase 2
• First received: October 7, 2009
• Last updated: July 28, 2011
• Start date: May 2010

Study information

• Verified date: July 2011
• Source: HemaQuest Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoid Malignancies
• Lymphoproliferative Disorders
• Neoplasms

Intervention

Drug:
• HQK-1004
1,000 mg/kg/day administered IV 24 hours/day for 5 days (Days 1-5 of each 21 day cycle)
• 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.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Feigin Center - Center for Cell and Gene Therapy	Houston	Texas
United States	Weill Cornell Medical College	New York	New York
United States	LPCH/Stanford	Palo Alto	California
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of California, San Francisco	San Francisco	California
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
HemaQuest Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		Days 21, 42, 84 and 126	No
Secondary	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	Yes
Secondary	Overall and progression-free survival		through end of treatment (up to Day 126), then every 8 weeks for 1 year post last dose	No