Bortezomib and Ganciclovir in Treating Patients With Relapsed or Refractory Epstein Barr Virus-Positive Lymphoma
Stopped early · Phase 1
Conditions studied: Lymphoma, Lymphoproliferative Disorder
In brief
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.
Key facts
- Study ID
- NCT00093704
- Run by
- Jonsson Comprehensive Cancer Center
- People needed
- 1
- Starts
- 2005-03-01
- Last updated by the study team
- 2020-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Jonsson Comprehensive Cancer Center at UCLA — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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