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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Lymphoid Malignancies Lymphoproliferative Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HQK-1004 + Valganciclovir

Group Type EXPERIMENTAL

HQK-1004

Intervention Type DRUG

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)

Intervention Type DRUG

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.

Interventions

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HQK-1004

1,000 mg/kg/day administered IV 24 hours/day for 5 days (Days 1-5 of each 21 day cycle)

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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arginine butyrate

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No