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

Not Recruiting

Trial ID: NCT00828009

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

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Maximilian Diehn, MD, PhD
Maximilian Diehn, MD, PhD

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

Professor of Radiation Oncology (Radiation Therapy)

Eligibility


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

Intervention(s):

biological: bevacizumab

drug: carboplatin

drug: cyclophosphamide

drug: paclitaxel

biological: Tecemotide

radiation: radiotherapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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