Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093704
Status:
TERMINATED
Last Update Posted:
2020-07-31
First Post:
2004-10-06
Brief Title:
Bortezomib and Ganciclovir in Treating Patients With Relapsed or Refractory Epstein Barr Virus-Positive Lymphoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study could not recruit any more patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MILLENNIUM-EBV-NHL-01 | None | None | None |
| UCLA-0403021-01 | None | None | None |
| MILLENNIUM-VEL-04-108 | None | None | None |