search
Back to results

Bortezomib and Ganciclovir in Treating Patients With Relapsed or Refractory Epstein Barr Virus-Positive Lymphoma

Primary Purpose

Lymphoma, Lymphoproliferative Disorder

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bortezomib + ganciclovir
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult Hodgkin lymphoma, recurrent adult Burkitt lymphoma, post-transplant lymphoproliferative disorder, recurrent adult grade III lymphomatoid granulomatosis, angioimmunoblastic T-cell lymphoma, adult grade III lymphomatoid granulomatosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Platelet count ≥ 50,000/mm^3 (no platelet transfusions within the past 4 weeks) Hepatic Bilirubin ≤ 2.0 times upper limit of normal (ULN) AST and ALT ≤ 2.5 times ULN (5 times ULN in patients with liver involvement) No active hepatitis B or C Renal Creatinine clearance ≥ 60 mL/min Sodium > 130 mmol/L Negative pregnancy test Fertile patients must use effective contraception HIV negative At least 4 weeks since prior immunotherapy At least 4 weeks since prior chemotherapy At least 4 weeks since prior radiotherapy More than 4 weeks since prior major surgery unless fully recovered Recovered from all prior therapy At least 4 weeks since prior investigational agents Exclusion Criteria: 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) concurrent radiotherapy other concurrent anticancer therapy other concurrent investigational agents

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bortezomib + ganciclovir

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 6, 2004
Last Updated
July 29, 2020
Sponsor
Jonsson Comprehensive Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00093704
Brief Title
Bortezomib and Ganciclovir in Treating Patients With Relapsed or Refractory Epstein Barr Virus-Positive Lymphoma
Official Title
EBV as Therapeutic Target: A Pilot Study of Inducing and Targeting EBV-TK in EBV-Positive Lymphomas by Combination of Bortezomib and Ganciclovir
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
study could not recruit any more patients
Study Start Date
March 2005 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Maximum Tolerated Dose (MTD) of bortezomib in patients with relapsed or refractory Epstein Barr virus-positive lymphoma. Secondary Assess the antitumor effect of this regimen in these patients. OUTLINE: This is a pilot, open-label, dose-escalation study of bortezomib. 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. Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 3-9 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Lymphoproliferative Disorder
Keywords
recurrent adult Hodgkin lymphoma, recurrent adult Burkitt lymphoma, post-transplant lymphoproliferative disorder, recurrent adult grade III lymphomatoid granulomatosis, angioimmunoblastic T-cell lymphoma, adult grade III lymphomatoid granulomatosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bortezomib + ganciclovir
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bortezomib + ganciclovir
Intervention Description
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.
Primary Outcome Measure Information:
Title
MTD of Bortezomib in patients with relapsed or refractory EBV + lymphomas
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Bortezomib in inducing lytic gene expression in EBV-infected lymphoma cells
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Platelet count ≥ 50,000/mm^3 (no platelet transfusions within the past 4 weeks) Hepatic Bilirubin ≤ 2.0 times upper limit of normal (ULN) AST and ALT ≤ 2.5 times ULN (5 times ULN in patients with liver involvement) No active hepatitis B or C Renal Creatinine clearance ≥ 60 mL/min Sodium > 130 mmol/L Negative pregnancy test Fertile patients must use effective contraception HIV negative At least 4 weeks since prior immunotherapy At least 4 weeks since prior chemotherapy At least 4 weeks since prior radiotherapy More than 4 weeks since prior major surgery unless fully recovered Recovered from all prior therapy At least 4 weeks since prior investigational agents Exclusion Criteria: 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) concurrent radiotherapy other concurrent anticancer therapy other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven De Vos, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Bortezomib and Ganciclovir in Treating Patients With Relapsed or Refractory Epstein Barr Virus-Positive Lymphoma

We'll reach out to this number within 24 hrs