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

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung Read More

Step 1 Inclusion Criteria:

• Histologically confirmed newly diagnosed nonsquamous non-small cell lung cancer (NSCLC), including the following subtypes:

  • Adenocarcinoma
  • Large cell undifferentiated
  • Bronchoalveolar cell
  • non-small cell carcinoma, 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 computerized tomography (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 Response Evaluation Criteria in Solid Tumours (RECIST) criteria
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• White blood cell (WBC) ≥ 4,000/mm³ OR Absolute neutrophil count (ANC) ≥ 2,000/mm³
• Platelet count ≥ 140,000/mm³
• Hemoglobin ≥ 9.0 g/dL
• Total bilirubin ≤ 1.5 mg/dL
• Aspartate aminotransferase (AST)/alanine aminotransferase (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
• Fertile patients must use effective contraception before, during, and for ≥ 6 months after completion of bevacizumab

Step 1 Exclusion Criteria:

• Significant pleural effusion
• CNS metastases by head CT scan or MRI within the past 4 weeks
• Pregnant or breast-feeding
• Prior chemotherapy or monoclonal antibodies for other cancers within 5 years prior to registration
• Prior chemotherapy for lung cancer
• Prior chest radiotherapy
• Ongoing (lasting > 14 days) or active infection or ongoing (lasting > 14 days) fever within the past 6 months
• Gross hemoptysis ≥ grade 2 (defined as ≥ ½ teaspoon of bright red blood per episode) within the past 3 months
• Bleeding ≥ grade 2 or any bleeding requiring intervention
• 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
• Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• Psychiatric illness or social situation that would limit compliance with study requirements
• History of uncontrolled hypertension (i.e., blood pressure ≥ 150/100 mm Hg) while on stable regimen of antihypertensive therapy
• Significant traumatic injury or serious non-healing wound, ulcer, or bone fracture within the past 4 weeks
• Concurrent major surgical procedure
• Having anticipated major surgical procedure(s) during the course of the study
• Concurrent daily aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory agents (NSAIDs) known to inhibit platelet function
• Recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies
• Pre-existing medical condition requiring chronic steroids or immunosuppressive therapy
• Autoimmune disease
• Known hepatitis B or C
• Immunotherapy (e.g., interferon, interleukin, sargramostim [GM-CSF], or filgrastim [G-CSF]) within 28 days prior to registration
• Prior splenectomy
• Hypersensitivity to any component of bevacizumab
• Prior core biopsy or any other minor surgical procedure, excluding the placement of a vascular access device, within 7 days prior to registration

Step 2 Inclusion Criteria:

• Serum creatinine ≤ 1.5 mg/ml or calculated creatinine clearance ≥ 45 ml/min
• Urine dipstick must be ≤ 0-1+. If urine dipstick results > 1+, 24 hour urine for protein must be obtained. Patients must have < 1g protein/24 hours to participate in the study
• Patient must be registered to step 2 within 28 days of completion of consolidation chemotherapy
• Patient must have met all eligibility requirements for Step 1
• Platelets ≥ 100,000/mm3

Step 2 Exclusion Criteria:

• Progressive disease or unevaluable disease per RECIST criteria upon post- consolidation chemotherapy evaluation
• Autoimmune disease