Bortezomib and Antiviral Therapy Followed By Effusion Drainage, Bevacizumab, and Combination Chem… (NCT00217503) | Clinical Trial Compass
CompletedPhase 2
Bortezomib and Antiviral Therapy Followed By Effusion Drainage, Bevacizumab, and Combination Chemotherapy in Treating Patients With Primary Effusion Lymphoma
United States15 participantsStarted 2005-07
Plain-language summary
RATIONALE: Herpesvirus is found in the cancer cells of patients with primary effusion lymphoma. Antiviral drugs, such as zidovudine and valganciclovir, may be able to act against the herpesvirus in the cancer cells to help kill the cancer cells. Bortezomib may help the antiviral drugs kill the cancer cells. Draining the effusion removes fluid that has built up. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with antiviral therapy followed by effusion drainage, bevacizumab, and combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with antiviral therapy followed by effusion drainage, bevacizumab, and combination chemotherapy works in treating patients with primary effusion 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.
DISEASE CHARACTERISTICS:
* Histologically confirmed primary effusion lymphoma (PEL) involving a body cavity
* Kaposi's sarcoma associated-herpesvirus
* Any anatomic site or distribution of involvement allowed
* HIV infection allowed
* Previously treated or untreated disease
* No mass lesions in the brain (for patients receiving bevacizumab during study treatment)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-3\* NOTE: \*ECOG 4 allowed if due to a mechanical effect of the PEL that can be corrected by effusion drainage resulting in improved performance status to ECOG 3 or better
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 75,000/mm\^3
* No active bleeding or coagulopathy (for patients receiving bevacizumab during study treatment)
Hepatic
* AST and ALT \< 3 times upper limit of normal (ULN) (6 times ULN if due to hyperalimentation)
* Bilirubin \< 2.0 mg/dL OR
* Total bilirubin ≤ 4.5 mg/dL AND direct bilirubin \< 0.4 mg/dL (for patients with Gilbert's syndrome or receiving protease-inhibitor therapy)
Renal
* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance \> 50 mL/min
Cardiovascular
* Patients receiving bevacizumab during study treatment must meet the following criteria:
* No deep venous or arterial thrombosis within the past 6 months
* No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 160 mm Hg or diastolic BP \> 95 mm Hg)
* No unstable ang…
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
Response to therapy as measured by overall, disease-free, and progression-free survival each month