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Trial record 1 of 1 for:    NCT 00828009
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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 September 2014 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: September 16, 2014
Last verified: September 2014
  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.


Condition Intervention Phase
Lung Cancer
Biological: bevacizumab
Biological: emepepimut-S
Drug: carboplatin
Drug: cyclophosphamide
Drug: paclitaxel
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: December 2010
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828009

  Show 88 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Jyoti D. Patel Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00828009     History of Changes
Other Study ID Numbers: CDR0000632611, E6508
Study First Received: January 22, 2009
Last Updated: September 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eastern Cooperative Oncology Group:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
large cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bevacizumab
Cyclophosphamide
Alkylating Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014