Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT00217503
Eligibility Criteria:
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 angina
* No New York Heart Association class II-IV congestive heart failure
* No cardiac arrhythmia requiring medication
* No clinically significant peripheral artery disease
* No peripheral vascular disease ≥ grade 2
* No prior myocardial infarction
* No transient ischemic attack or cerebral vascular accident within the past 6 months
* No other clinically significant cardiovascular disease
Neurologic
* Patients receiving bevacizumab during study treatment must meet the following criteria:
* No uncontrolled seizure disorder
* No CNS bleeding within the past 6 months
* No other substantial CNS disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy requiring treatment that would preclude study treatment, including, but not limited to, any of the following:
* Life-threatening Kaposi's sarcoma
* Non-resectable lung cancer
* Acute leukemia
* No grade IV organ dysfunction unrelated to PEL
* No infection requiring chronic systemic therapy that would preclude study treatment (except HIV, hepatitis B, or hepatitis C), including, but not limited to, any of the following:
* Invasive aspergillosis
* End-organ cytomegalovirus (CMV)
* CMV retinitis (e.g., ocular implants not requiring systemic therapy) allowed if controlled with local therapy
* No other condition or circumstance that would preclude study participation
* No gastrointestinal bleeding within the past 6 months (for patients receiving bevacizumab during study treatment)
* No pathological condition that would confer a high risk for bleeding (for patients receiving bevacizumab during study treatment)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No live virus vaccines (e.g., vaccinia or rotavirus) or bacterial vaccines during and for 3 months after completion of study treatment
Chemotherapy
* No prior cumulative anthracycline dose \> 450 mg/m\^2 (unless cardiac ejection fraction normal)
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No concurrent chronic daily aspirin ≥ 325 mg/day or nonsteroidal medication that interferes with platelet function (for patients receiving bevacizumab during study treatment)
* No concurrent therapeutic anticoagulation (INR \> 1.5) unless patient is on full-dose warfarin (for patients receiving bevacizumab during study treatment)
* Full-dose anticoagulants allowed provided both of the following criteria are met:
* INR normal
* On a stable dose of warfarin or low-molecular weight heparin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00217503
Study Brief:
Protocol Section:
NCT00217503