Vaccination Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00003279
- Brief Summary
RATIONALE: Vaccines may help the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of vaccination with monoclonal antibody BEC2 and BCG with that of no further therapy in treating patients who have limited-stage small cell lung cancer.
- Detailed Description
OBJECTIVES: I. Determine the impact of adjuvant monoclonal antibody BEC2 and BCG on survival of patients with limited stage small cell lung cancer. II. Determine the safety of this regimen in these patients. III. Determine progression-free survival and quality of life of these patients treated with this regimen.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, Karnofsky performance status (60-70% vs 80-100%), and response to first-line combined modality treatment (complete vs partial). Within 3-7 weeks after completion of prior induction chemoradiotherapy, responding patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive best supportive care and are observed until disease progression is documented. Arm II: Patients receive adjuvant monoclonal antibody BEC2 and BCG intradermally on day 1 of weeks 0, 2, 4, 6, and 10. Treatment consists of 5 vaccinations over a period of 10 to 12 weeks in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline, at weeks 6, 12, and 24, and then every 6 months thereafter. Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 500 patients will be accrued for this study within 4 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
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
Related Research Topics
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Trial Locations
- Locations (77)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Mercy Hospital
🇺🇸Miami, Florida, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
University Hospital
🇨🇭Basel, Switzerland
St. Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Norwich Cancer Center
🇺🇸Norwich, Connecticut, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
Royal Marsden Hospital
🇬🇧Sutton, England, United Kingdom
Bennett Cancer Center
🇺🇸Stamford, Connecticut, United States
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Twee Steden Ziekenhuis Vestiging Tilburg
🇳🇱Tilburg, Netherlands
Southwest Cancer Clinic
🇺🇸Las Vegas, Nevada, United States
Peter MacCallum Cancer Institute
🇦🇺East Melbourne, Victoria, Australia
Veterans Affairs Medical Center - West Roxbury
🇺🇸West Roxbury, Massachusetts, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Academisch Ziekenhuis der Vrije Universiteit
🇳🇱Amsterdam, Netherlands
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Colorado Permanente Medical Group, P.C.
🇺🇸Denver, Colorado, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Scripps Clinic and Research Foundation - La Jolla
🇺🇸La Jolla, California, United States
Ciudad Sanitaria Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario de Elche
🇪🇸Elche, Spain
Hospital Clinic y Provincial de Barcelona
🇪🇸Barcelona, Spain
Kantonsspital - Saint Gallen
🇨🇭Saint Gallen, Switzerland
Hospital Arnau Vilanova
🇪🇸Valencia, Spain
Hospital de la Princesa
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Nostra Senora Aranzazu
🇪🇸San Sebastian, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario LA FE
🇪🇸Valencia, Spain
Hospital General Universitario Valencia
🇪🇸Valencia, Spain
Marienhospital/Ruhr University Bochum
🇩🇪Herne, Germany
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Inselspital, Bern
🇨🇭Bern, Switzerland
Ratisches Kantons und Regionalspital
🇨🇭Chur, Switzerland
Hospital de la Santa Cruz I Sant Pau
🇪🇸Barcelona, Spain
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Monash Medical Center
🇦🇺East Bentweigh, Victoria, Australia
Ziekenhuis St Jansdal
🇳🇱Harderwijk, Netherlands
Hospital de Cruces
🇪🇸Barakaldo, Bilbao, Spain
Sint Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Wellington Cancer Centre
🇳🇿Wellington, New Zealand
Greenwich Hospital Association
🇺🇸Greenwich, Connecticut, United States
Memorial Regional Cancer Center
🇺🇸Hollywood, Florida, United States
Columbia - HCA Cancer Research Network
🇺🇸North Miami Beach, Florida, United States
Georgia Cancer Specialists
🇺🇸Decatur, Georgia, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Oklahoma Oncology Inc.
🇺🇸Tulsa, Oklahoma, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Akron City Hospital
🇺🇸Akron, Ohio, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Royal Prince Alfred Hospital, Sydney
🇦🇺Camperdown, New South Wales, Australia
Newcastle Mater Misericordiae Hospital
🇦🇺Newcastle, New South Wales, Australia
Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Nepean Hospital
🇦🇺Penrith, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
NSW Breast Cancer Institute
🇦🇺Westmead, New South Wales, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Pulmologisches Zentrum Der Stadt Wien
🇦🇹Vienna (Wein), Austria
Universitaetsklinikum Benjamin Franklin
🇩🇪Berlin, Germany
Asklepios Fachkliniken Munchen- Gauting
🇩🇪Gauting, Munich (Munchen), Germany
Groot Ziekengasthuis 's-Hertogenbosch
🇳🇱's-Hertogenbosch, Netherlands
Hospital Grosshansdorf
🇩🇪Grosshansdorf, Germany
Thoraxklinik Rohrbach
🇩🇪Heidelberg, Germany
Green Lane Hospital
🇳🇿Auckland, New Zealand
University of Nevada - Reno
🇺🇸Reno, Nevada, United States