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Status:

COMPLETED

Bortezomib and Antiviral Therapy Followed By Effusion Drainage, Bevacizumab, and Combination Chemotherapy in Treating Patients With Primary Effusion Lymphoma

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 th...

Detailed Description

OBJECTIVES: Primary * Determine the complete response rate in patients with previously untreated primary effusion lymphoma treated with effusion drainage and bevacizumab in combination with chemothe...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 1 2007

    Estimated Enrollment :

    15 Patients enrolled

    Trial Details

    Trial ID

    NCT00217503

    Start Date

    July 1 2005

    End Date

    June 1 2007

    Last Update

    June 20 2013

    Active Locations (1)

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    Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, United States, 20892-1182