NCT00093704

Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Epstein Barr virus can cause cancer and lymphoproliferative disorders. Ganciclovir is an antiviral drug that acts against the Epstein Barr virus. Giving ganciclovir together with bortezomib may kill more Epstein Barr virus-infected cancer cells. PURPOSE: This clinical trial is studying how well giving bortezomib together with ganciclovir works in treating patients with relapsed or refractory Epstein Barr virus-positive lymphoma.

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_1 lymphoma

Geographic Reach
1 country

1 active site

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 6, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2004

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2005

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Last Updated

July 31, 2020

Status Verified

August 1, 2012

Enrollment Period

5.3 years

First QC Date

October 6, 2004

Last Update Submit

July 29, 2020

Conditions

LymphomaLymphoproliferative Disorder

Keywords

recurrent adult Hodgkin lymphomarecurrent adult Burkitt lymphomapost-transplant lymphoproliferative disorderrecurrent adult grade III lymphomatoid granulomatosisangioimmunoblastic T-cell lymphomaadult grade III lymphomatoid granulomatosis

Outcome Measures

Primary Outcomes (1)

  • MTD of Bortezomib in patients with relapsed or refractory EBV + lymphomas

    3 weeks

Secondary Outcomes (1)

  • Bortezomib in inducing lytic gene expression in EBV-infected lymphoma cells

    3 weeks

Study Arms (1)

Bortezomib + ganciclovir

EXPERIMENTAL

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8 and 11. Patients also receive ganciclovir IV twice daily on days 1-14. Treatment repeats every 21 days for a maximum of 3 courses.

Drug: bortezomib + ganciclovir

Interventions

bortezomib + ganciclovirDRUG

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8 and 11. Patients also receive ganciclovir IV twice daily on days 1-14. Treatment repeats every 21 days for a maximum of 3 courses.

Bortezomib + ganciclovir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed Epstein Barr virus-positive lymphoma, including the following subtypes:
  • Post-transplantation lymphoma
  • Burkitt's lymphoma
  • Hodgkin's lymphoma
  • T-/NK-cell lymphoma
  • Unresponsive to, or relapsed after, at least 1 prior chemotherapy regimen
  • Bidimensionally measurable disease by CT scan
  • At least 1 lesion ≥ 1.5 cm in the greatest diameter
  • Age 18 and over
  • ECOG 0-2 OR
  • Karnofsky 50-100%
  • Life expectancy More than 3 months
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,000/mm\^3 (no growth factor support within the past 4 weeks)
  • Hemoglobin ≥ 9.0 g/dL
  • +17 more criteria

You may not qualify if:

  • primary or secondary CNS lymphoma or HIV-related lymphoma
  • known brain metastases
  • myocardial infarction within the past 6 months
  • acute ischemia or new conduction system abnormalities by electrocardiogram
  • symptomatic congestive heart failure
  • unstable angina pectoris
  • cardiac arrhythmia
  • hospitalized
  • pregnant or nursing
  • other uncontrolled illness
  • ongoing or active systemic infection
  • psychiatric illness or social situation that would preclude study compliance
  • history of allergic reaction attributable to compounds of similar chemical or biological composition to study drugs
  • sensitivity to boron, mannitol, bortezomib, or ganciclovir
  • concurrent corticosteroids (≥ 10 mg of prednisone or equivalent)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

LymphomaLymphoproliferative DisordersHodgkin DiseaseBurkitt LymphomaImmunoblastic Lymphadenopathy

Interventions

BortezomibGanciclovir

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphadenopathy

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Sven De Vos, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2004

First Posted

October 8, 2004

Study Start

March 1, 2005

Primary Completion

July 1, 2010

Last Updated

July 31, 2020

Record last verified: 2012-08

Locations

US(1)