Bortezomib and Ganciclovir in Treating Patients With Relapsed or Refractory Epstein Barr Virus-Po… (NCT00093704) | Clinical Trial Compass
TerminatedPhase 1
Bortezomib and Ganciclovir in Treating Patients With Relapsed or Refractory Epstein Barr Virus-Positive Lymphoma
Stopped: study could not recruit any more patients
United States1 participantsStarted 2005-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mont…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MTD of Bortezomib in patients with relapsed or refractory EBV + lymphomas