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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by Eastern Cooperative Oncology Group.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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   (Adult, Senior)
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

  Hide Study Locations
Locations
United States, California
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States, 94304
Stanford Cancer Center
Stanford, California, United States, 94305-5824
United States, Georgia
Medical Center of Central Georgia
Macon, Georgia, United States, 31208
United States, Illinois
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
Saint Joseph Hospital
Chicago, Illinois, United States, 60657
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Mason District Hospital
Havana, Illinois, United States, 62644
Kellogg Cancer Care Center
Highland Park, Illinois, United States, 60035
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
Provena St. Mary's Regional Cancer Center - Kankakee
Kankakee, Illinois, United States, 60901
North Shore Oncology and Hematology Associates, Limited - Libertyville
Libertyville, Illinois, United States, 60048
McDonough District Hospital
Macomb, Illinois, United States, 61455
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, United States, 61265
Cancer Care and Hematology Specialists of Chicagoland - Niles
Niles, Illinois, United States, 60714
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Proctor Hospital
Peoria, Illinois, United States, 61614
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
Hematology Oncology Associates - Skokie
Skokie, Illinois, United States, 60076
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, United States, 50325
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51102
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Massachusetts
Tufts Medical Center Cancer Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States, 49085
United States, Nebraska
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Lakeside Hospital
Omaha, Nebraska, United States, 68130
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
United States, New Jersey
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
United States, New York
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794-9446
United States, Ohio
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States, 44708
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
St. Rita's Medical Center
Lima, Ohio, United States, 45801
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Harrisburg, Pennsylvania, United States, 17110-2098
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States, 18201
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, United States, 19464
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
United States, West Virginia
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Jyoti D. Patel Robert H. Lurie Cancer Center
  More Information

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

ClinicalTrials.gov processed this record on December 07, 2016