Bortezomib and Ganciclovir in Treating Patients With Relapsed or Refractory Epstein Barr Virus-Positive Lymphoma
This study has been terminated.
(study could not recruit any more patients)
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00093704
First received: October 6, 2004
Last updated: August 2, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Lymphoproliferative Disorder |
Drug: bortezomib + ganciclovir |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Jonsson Comprehensive Cancer Center:
Primary Outcome Measures:
- MTD of Bortezomib in patients with relapsed or refractory EBV + lymphomas [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Bortezomib in inducing lytic gene expression in EBV-infected lymphoma cells [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 1 |
| Study Start Date: | March 2005 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bortezomib + ganciclovir
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
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093704
Locations
| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
| Principal Investigator: | Sven De Vos, MD | Jonsson Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00093704 History of Changes |
| Other Study ID Numbers: | CDR0000389476, P30CA016042, UCLA-0403021-01, MILLENNIUM-VEL-04-108, MILLENNIUM-EBV-NHL-01 |
| Study First Received: | October 6, 2004 |
| Last Updated: | August 2, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoproliferative Disorders Neoplasms by Histologic Type Neoplasms Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Ganciclovir Bortezomib |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013