Last updated on March 2019

BLP25 Liposome Vaccine and Bevacizumab After Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lung Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Histologically confirmed newly diagnosed nonsquamous cell non-small cell lung cancer
    (NSCLC), including the following subtypes:
    Large cell undifferentiated
    Bronchoalveolar cell
    NSCLC, not otherwise specified
    Unresectable stage IIIA or stage IIIB disease
    Patients with stage IIIA disease with mediastinal lymph node enlargement between
    1 cm and 2.0 cm on CT scan must have these nodes biopsied (pathologic
    confirmation) to rule out resectability
    Metastases to contralateral mediastinal or supraclavicular nodes allowed
    Measurable or non-measurable disease, as defined by RECIST criteria
    No significant pleural effusion as defined by either of the following:
    Pleural effusion is seen on CT scan only (not seen on chest x-ray)
    Pleural effusion does not reaccumulate within 1 week after thoracentesis AND is
    cytologically negative
    No CNS metastases by head CT scan or MRI within the past 4 weeks
    ECOG performance status 0-1
    WBC ≥ 4,000/mm³ OR ANC ≥ 2,000/mm³
    Platelet count ≥ 140,000/mm³
    Hemoglobin ≥ 9.0 g/dL
    Total bilirubin ≤ 1.5 mg/dL
    AST/ALT ≤ 2.5 times upper limit of normal
    Serum creatinine ≤ 1.5 mg/mL OR creatinine clearance ≥ 45 mL/min
    Urine protein:creatinine ratio < 1.0 by urine dipstick OR < 1 g of protein by 24-hour
    urine collection
    INR ≤ 1.5 OR ≤ 3.0 if patient is on therapeutic anticoagulation
    PTT normal
    Not pregnant or nursing
    Negative pregnancy test
    Fertile patients must use effective contraception before, during, and for ≥ 6 months
    after completion of bevacizumab
    No other active malignancies
    No known hepatitis B or C
    No ongoing (lasting > 14 days) or active infection or ongoing (lasting > 14 days)
    fever within the past 6 months
    No gross hemoptysis ≥ grade 2 (defined as ≥ ½ teaspoon of bright red blood per
    episode) within the past 3 months
    No pulmonary hemoptysis
    Confirmed extrapulmonary hemoptysis allowed
    No bleeding ≥ grade 2 or any bleeding requiring intervention
    No history of bleeding diathesis or coagulopathy
    No cardiac dysfunction, including any of the following:
    Clinically significant cardiovascular disease
    Myocardial infarction within the past 6 months
    New York Heart Association class III-IV congestive heart failure
    Unstable angina pectoris
    Serious cardiac arrhythmia requiring medication within the past 4 weeks
    History of hypertensive crisis or hypertensive encephalopathy
    Stroke or transient ischemic attack within the past 6 months
    Peripheral vascular disease ≥ grade 2 within the past 6 months
    No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
    the past 6 months
    No psychiatric illness or social situation that would limit compliance with study
    No history of uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg) while
    on stable regimen of antihypertensive therapy
    No significant traumatic injury or serious non-healing wound, ulcer, or bone fracture
    within the past 4 weeks
    No recognized immunodeficiency disease, including cellular immunodeficiencies,
    hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital
    No pre-existing medical condition requiring chronic steroids or immunosuppressive
    No autoimmune disease
    No known hypersensitivity to any component of bevacizumab
    See Disease Characteristics
    More than 4 weeks since prior open biopsy or major surgical procedure
    More than 28 days since prior immunotherapy (e.g., interferon, interleukin,
    argramostim [GM-CSF], or filgrastim [G-CSF])
    Patients must not have had prior chemotherapy or monoclonal antibodies for other
    cancers within 5 years prior to registration
    More than 7 says since prior core biopsy or any other minor surgical procedure,
    excluding the placement of a vascular access device
    No prior chemotherapy for lung cancer
    No prior chest radiotherapy
    No prior splenectomy
    Concurrent stable regimen of therapeutic anticoagulation or prophylactic
    anticoagulation for venous access devices allowed provided coagulation studies met
    entry criteria
    No concurrent daily aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory agents
    (NSAIDs) known to inhibit platelet function
    No concurrent dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel bisulfate
    (Plavix), and/or cilostazol (Pletal)
    No concurrent major surgical procedure

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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