NCT00992732

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Last Updated

August 1, 2011

Status Verified

July 1, 2011

Enrollment Period

6 months

First QC Date

October 7, 2009

Last Update Submit

July 28, 2011

Conditions

Lymphoid MalignanciesLymphoproliferative Disorders

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

    Days 21, 42, 84 and 126

Secondary Outcomes (2)

  • Safety and tolerability as measured by adverse events, physical exams, ECG, and laboratory evaluations

    through end of treatment (up to Day 126) and 30 days post last dose

  • Overall and progression-free survival

    through end of treatment (up to Day 126), then every 8 weeks for 1 year post last dose

Study Arms (1)

HQK-1004 + Valganciclovir

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

Interventions

HQK-1004DRUG

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

Also known as: arginine butyrate
HQK-1004 + Valganciclovir
Valganciclovir (may substitute with ganciclovir)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.

HQK-1004 + Valganciclovir

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

LPCH/Stanford

Palo Alto, California, 94304, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Feigin Center - Center for Cell and Gene Therapy

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoproliferative Disorders

Interventions

arginine butyrateValganciclovirGanciclovir

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ron Berenson, MD

    HemaQuest Pharmaceuticals Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 9, 2009

Study Start

May 1, 2010

Primary Completion

November 1, 2010

Last Updated

August 1, 2011

Record last verified: 2011-07

Locations

US(8)