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