Status:
TERMINATED
Study of HQK-1004 and Valganciclovir to Treat Epstein-Barr Virus (EBV) - Positive Lymphoid Malignancies or Lymphoproliferative Disorders
Lead Sponsor:
HemaQuest Pharmaceuticals Inc.
Conditions:
Lymphoid Malignancies
Lymphoproliferative Disorders
Eligibility:
All Genders
3+ years
Phase:
PHASE2
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 lymphoprolif...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00992732
Start Date
May 1 2010
Last Update
August 1 2011
Active Locations (8)
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1
LPCH/Stanford
Palo Alto, California, United States, 94304
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110