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
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
Masking: Open Label, Primary Purpose: Treatment
Safety
Yes
Jyoti D. Patel
Study Chair
Robert H. Lurie Cancer Center
Unspecified
CDR0000632611
NCT00828009
December 2010
Name | Location |
---|---|
CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Mercy Cancer Center at Mercy Medical Center | Canton, Ohio 44708 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Geisinger Medical Group - Scenery Park | State College, Pennsylvania 16801 |
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Medical Center of Central Georgia | Macon, Georgia 31201 |
Cancer Institute of New Jersey at Hamilton | Hamilton, New Jersey 08690 |
Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Lewistown Hospital | Lewistown, Pennsylvania 17044 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
Swedish-American Regional Cancer Center | Rockford, Illinois 61104-2315 |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
West Virginia University Health Sciences Center - Charleston | Charleston, West Virginia 25302 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Howard Community Hospital | Kokomo, Indiana 46904 |
Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Parkland Memorial Hospital | Dallas, Texas 75235 |
Hematology Oncology Associates - Skokie | Skokie, Illinois 60076 |
St. Joseph Medical Center | Bloomington, Illinois 61701 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Hematology and Oncology Associates | Chicago, Illinois 60611 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Mason District Hospital | Havana, Illinois 62644 |
North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville, Illinois 60048 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
OSF St. Francis Medical Center | Peoria, Illinois 61637 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Immanuel Medical Center | Omaha, Nebraska 68122 |
Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
Pottstown Memorial Regional Cancer Center | Pottstown, Pennsylvania 19464 |
Cancer Center at Ball Memorial Hospital | Muncie, Indiana 47303 |
Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
Stanford Cancer Center | Stanford, California 94305-5824 |
Saint Joseph Hospital | Chicago, Illinois 60657 |
Kellogg Cancer Care Center | Highland Park, Illinois 60035 |
Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles, Illinois 60714 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
Geisinger Hazleton Cancer Center | Hazleton, Pennsylvania 18201 |
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Regional Cancer Center at Oconomowoc Memorial Hospital | Oconomowoc, Wisconsin 53066 |
PinnacleHealth Regional Cancer Center at Polyclinic Hospital | Harrisburg, Pennsylvania 17105 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline, Illinois 61265 |
Provena St. Mary's Regional Cancer Center - Kankakee | Kankakee, Illinois 60901 |
Tufts Medical Center Cancer Center | Boston, Massachusetts 02111 |
Lakeside Hospital | Omaha, Nebraska 68130 |