EBV as Therapeutic Target: A Pilot Study of Inducing and Targeting EBV-TK in EBV-Positive Lymphomas by Combination of Bortezomib and Ganciclovir
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of Bortezomib in patients with relapsed or refractory EBV + lymphomas
3 weeks
Yes
Sven De Vos, MD
Principal Investigator
Jonsson Comprehensive Cancer Center
United States: Federal Government
CDR0000389476
NCT00093704
March 2005
Name | Location |
---|---|
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |