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

HemaQuest Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Lymphoid Malignancies

Lymphoproliferative Disorders

Treatments

Drug: HQK-1004

Drug: Valganciclovir (may substitute with ganciclovir)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00992732

HQP-1004-EB-03

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

3+ years old

Volunteers

No 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