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



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:12/16/2017
Start Date:December 22, 2010
End Date:June 30, 2023

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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

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.

OBJECTIVES:

Primary

- To determine the safety of BLP25 liposome vaccine and bevacizumab after definitive
chemoradiotherapy and consolidation chemotherapy in patients with newly diagnosed,
unresectable stage IIIA or IIIB nonsquamous cell non-small cell lung cancer.

Secondary

- To evaluate the overall survival and progression-free in patients treated with this
regimen.

- To evaluate the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

- Chemoradiotherapy: Patients receive paclitaxel IV over 1 hour and carboplatin IV over
15-30 minutes once a week for 6 weeks. Patients also undergo concurrent definitive
radiotherapy 5 days a week for 6½ weeks. Patients with complete response (CR), partial
response (PR), or stable disease (SD) proceed to consolidation chemotherapy.

- Consolidation chemotherapy: Patients receive paclitaxel IV over 3 hours and carboplatin
IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the
absence of disease progression or unacceptable toxicity. Patients with CR, PR, or SD
proceed to maintenance therapy.

- Maintenance therapy: Patients receive a single dose of cyclophosphamide IV over 15-30
minutes 3 days before the first dose of bevacizumab and BLP25 liposome vaccine. Patients
then receive bevacizumab IV over 30-90 minutes on day 1 and BLP25 liposome vaccine
subcutaneously on days 1, 8, and 15 of courses 1 and 2 and on day 1 of every other
course beginning in course 4. Treatment repeats every 21 days for up to 34 courses in
the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

DISEASE CHARACTERISTICS:

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

- Adenocarcinoma

- 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

PATIENT CHARACTERISTICS:

- 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
requirements

- 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
immunodeficiencies

- No pre-existing medical condition requiring chronic steroids or immunosuppressive
therapy

- No autoimmune disease

- No known hypersensitivity to any component of bevacizumab

PRIOR CONCURRENT THERAPY:

- 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,
sargramostim [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
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