Vaccine Therapy Plus Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer That Has Been Completely Removed in Surgery
- Conditions
- Lung Cancer
- Registration Number
- NCT00006470
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these two treatments may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with radiation therapy in treating patients who have stage II or stage IIIA non-small cell lung cancer that has been completely removed in surgery.
- Detailed Description
OBJECTIVES:
* Determine the humoral and T-cell response to adjuvant monoclonal antibody 11D10 anti-idiotype vaccine and monoclonal antibody 3H1 anti-idiotype vaccine with radiotherapy in patients with completely resected stage II or IIIA non-small cell lung cancer.
* Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
* Determine the progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive monoclonal antibody 11D10 anti-idiotype vaccine and monoclonal antibody 3H1 anti-idiotype vaccine intracutaneously in separate sites once weekly for 3 weeks beginning 2-7 weeks (no later than 49 days) after surgery and then subcutaneously once monthly for 2 years regardless of disease progression. Beginning no more than 1 week after the third postoperative vaccination, all patients undergo radiotherapy 5 days a week for 5-6 weeks. Patients with extracapsular nodal metastases or T3 lesions also undergo 6 additional radiotherapy boosts.
Patients are followed at 4-6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (237)
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Harbor Hospital Center
🇺🇸Baltimore, Maryland, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Community Regional Cancer Care
🇺🇸Indianapolis, Indiana, United States
Clarian Health Partners Inc.
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Newfoundland Cancer Treatment and Research Foundation
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Latter Day Saints Hospital
🇺🇸Salt Lake City, Utah, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Veterans Affairs Medical Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Community Memorial Hospital
🇺🇸Menomonee Falls, Wisconsin, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
University of Tennessee Cancer Institute
🇺🇸Memphis, Tennessee, United States
Roger Williams Medical Center/BUSM
🇺🇸Providence, Rhode Island, United States
Mercy Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Mercy Hospital Cancer Center - Scranton
🇺🇸Scranton, Pennsylvania, United States
York Cancer Center
🇺🇸York, Pennsylvania, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Yakima Valley Memorial Hospital
🇺🇸Yakima, Washington, United States
Southern Wisconsin Radiotherapy Center
🇺🇸Madison, Wisconsin, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
🇺🇸Green Bay, Wisconsin, United States
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
🇨🇦Thunder Bay, Ontario, Canada
Schiffler Cancer Center
🇺🇸Wheeling, West Virginia, United States
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
All Saints Cancer Center
🇺🇸Racine, Wisconsin, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
St. Anthony Hospital
🇺🇸Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Nova Scotia Cancer Centre
🇨🇦Halifax, Nova Scotia, Canada
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada
CHUS-Hopital Fleurimont
🇨🇦Fleurimont, Quebec, Canada
McGill University
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Columbia Hospital
🇺🇸Milwaukee, Wisconsin, United States
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Sutter Health West Cancer Research Group
🇺🇸Greenbrae, California, United States
William Beaumont Hospital - Troy
🇺🇸Troy, Michigan, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
St. John's Medical Center
🇺🇸Anderson, Indiana, United States
Radiation Oncology Center - Sacramento
🇺🇸Sacramento, California, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Methodist Hospital Cancer Center - Omaha
🇺🇸Omaha, Nebraska, United States
Nebraska Health System
🇺🇸Omaha, Nebraska, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
DCH Cancer Treatment Center
🇺🇸Tuscaloosa, Alabama, United States
Mount Diablo Medical Center
🇺🇸Concord, California, United States
Abgenix
🇺🇸Fremont, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Saint Agnes Cancer Center
🇺🇸Fresno, California, United States
California Cancer Center
🇺🇸Fresno, California, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
Huntington Cancer Center
🇺🇸Pasadena, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Radiation Medical Group, Incorporated
🇺🇸San Diego, California, United States
Robert and Beverly Lewis Family Cancer Care Center
🇺🇸Pomona, California, United States
O'Connor Hospital
🇺🇸San Jose, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
Florida Radiation Oncology Group
🇺🇸Jacksonville, Florida, United States
Saint Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
Veterans Affairs Medical Center - Miami
🇺🇸Miami, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Tallahassee Memorial Healthcare
🇺🇸Tallahassee, Florida, United States
Sarasota Radiation and Medical Oncology Center
🇺🇸Sarasota, Florida, United States
Gulf Coast Cancer Treatment Center
🇺🇸Panama City, Florida, United States
Bay Medical Center
🇺🇸Panama City, Florida, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Medical Center/John B. Amos Community Cancer Center
🇺🇸Columbus, Georgia, United States
Regional Radiation Oncology Center at Rome
🇺🇸Rome, Georgia, United States
Northwest Community Hospital
🇺🇸Arlington Heights, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Bloomington Hospital
🇺🇸Bloomington, Indiana, United States
Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
Wendt Regional Cancer Center of Finley Hospital
🇺🇸Dubuque, Iowa, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Merle M. Mahr Cancer Center
🇺🇸Madisonville, Kentucky, United States
Cancer Center at Lexington Clinic
🇺🇸Lexington, Kentucky, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Anne Arundel Oncology Center
🇺🇸Annapolis, Maryland, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Greater Baltimore Medical Center and Cancer Center
🇺🇸Baltimore, Maryland, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Peninsula Regional Medical Center
🇺🇸Salisbury, Maryland, United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
🇺🇸Jamaica Plain, Massachusetts, United States
McLaren Regional Cancer Center
🇺🇸Flint, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Marquette General Hospital
🇺🇸Marquette, Michigan, United States
MidMichigan Medical Center - Midland
🇺🇸Midland, Michigan, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Mallinckrodt Institute of Radiology
🇺🇸Saint Louis, Missouri, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Elliot Regional Cancer Center
🇺🇸Manchester, New Hampshire, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
South Jersey Regional Cancer Center
🇺🇸Millville, New Jersey, United States
Trinitas Hospital - Jersey Street Campus
🇺🇸Elizabeth, New Jersey, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
John F. Kennedy Medical Center
🇺🇸Edison, New Jersey, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Atlantic City Medical Center
🇺🇸Pomona, New Jersey, United States
St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
🇺🇸Mount Holly, New Jersey, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Associated Radiologists, P.A.
🇺🇸Warren, New Jersey, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
Radiation Oncology Associates of Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Cancer Center of Albany Medical Center
🇺🇸Albany, New York, United States
State University of New York Health Science Center at Brooklyn
🇺🇸Brooklyn, New York, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Finger Lakes Radiation Oncology Center
🇺🇸Clifton Springs, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Champlain Valley Physicians Hospital Medical Center
🇺🇸Plattsburgh, New York, United States
James P. Wilmot Cancer Center
🇺🇸Rochester, New York, United States
Vassar Brothers Medical Center
🇺🇸Poughkeepsie, New York, United States
Riverhill Radiation Oncology
🇺🇸Yonkers, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Northeast Medical Center
🇺🇸Concord, North Carolina, United States
Trinity Cancer Care Center
🇺🇸Minot, North Dakota, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
James P. Wilmot Cancer Center at the University of Rochester Medical Center
🇺🇸Rochester, New York, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
St. John Health System
🇺🇸Tulsa, Oklahoma, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Pocono Cancer Center
🇺🇸East Stroudsburg, Pennsylvania, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Mercy Fitzgerald Hospital
🇺🇸Darby, Pennsylvania, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
St. Luke's Hospital Cancer Center
🇺🇸Bethlehem, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Wilkes Barre General Hospital
🇺🇸Wilkes-Barre, Pennsylvania, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
RMH Regional Cancer Center
🇺🇸Harrisonburg, Virginia, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Bon Secours - St. Mary's Hospital
🇺🇸Richmond, Virginia, United States
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
Gundersen Lutheran Medical Foundation
🇺🇸La Crosse, Wisconsin, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Waukesha Memorial Hospital Regional Cancer Center
🇺🇸Waukesha, Wisconsin, United States
Northeastern Ontario Regional Cancer Centre, Sudbury
🇨🇦Sudbury, Ontario, Canada
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
MD Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States
Hospital of St. Raphael
🇺🇸New Haven, Connecticut, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Louisville Radiation Oncology
🇺🇸Louisville, Kentucky, United States
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada