Trial Search Results

Study of HQK-1004 and Valganciclovir to Treat Epstein-Barr Virus (EBV) - 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

HemaQuest Pharmaceuticals Inc.

Intervention(s):

  • Drug: HQK-1004
  • Drug: Valganciclovir (may substitute with ganciclovir)

Phase:

Phase 2

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

Ages Eligible for Study

3 Years - N/A

Genders Eligible for Study

All