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

Trial ID or NCT#

NCT00828009

Status

not recruiting iconNOT RECRUITING

Purpose

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vaccine therapy together with bevacizumab after chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving BLP25 liposome vaccine together with 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.

Official Title

A Phase II Study of L-BLP25 and Bevacizumab in Unresectable Stage IIIA and IIIB Non-Squamous Non-Small Cell Lung Cancer After Definitive Chemoradiation

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Professor of Medicine (Oncology)
Joel Neal, MD, PhD
Joel Neal, MD, PhD
Medical oncologist, Thoracic specialist
Associate Professor of Medicine (Oncology)
Maximilian Diehn, MD, PhD
Maximilian Diehn, MD, PhD
Radiation oncologist
Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)
Billy W Loo, Jr, MD PhD FASTRO FACR
Billy W Loo, Jr, MD PhD FASTRO FACR
Radiation oncologist, Thoracic specialist
Professor of Radiation Oncology (Radiation Therapy)

Contact us to find out if this trial is right for you.

CONTACT

CCTO
(650) 498-7061