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 study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Eastern Cooperative Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00828009
First received: January 22, 2009
Last updated: February 7, 2014
Last verified: October 2012

January 22, 2009
February 7, 2014
December 2010
January 2016   (final data collection date for primary outcome measure)
Safety [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00828009 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Biological: bevacizumab
  • Biological: emepepimut-S
  • Drug: carboplatin
  • Drug: cyclophosphamide
  • Drug: paclitaxel
  • Radiation: radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
55
Not Provided
January 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT00828009
CDR0000632611, E6508
Not Provided
Eastern Cooperative Oncology Group
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Jyoti D. Patel Robert H. Lurie Cancer Center
Eastern Cooperative Oncology Group
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP