Clinical trial NCT00992732: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoid Malignancies
Lymphoproliferative Disorders
Lead sponsor: HemaQuest Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 1
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall response rate
timeFrame: Days 21, 42, 84 and 126
Secondary outcomes:
measure: Safety and tolerability as measured by adverse events, physical exams, ECG, and laboratory evaluations
timeFrame: through end of treatment (up to Day 126) and 30 days post last dose
measure: Overall and progression-free survival
timeFrame: through end of treatment (up to Day 126), then every 8 weeks for 1 year post last dose
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: LPCH/Stanford
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Feigin Center - Center for Cell and Gene Therapy
state: Texas
Study officials:
affiliation: HemaQuest Pharmaceuticals Inc.
name: Ron Berenson, MD
role: STUDY_DIRECTOR
References: