Vaccination Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
NCT ID: NCT00003279
Last Updated: 2012-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
1998-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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BCG vaccine
monoclonal antibody BEC2
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater that 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: AST less than 1.5 times upper limit of normal Hepatitis B negative Renal: Not specified Cardiovascular: Adequate cardiac function Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception No prior malignancy within 5 years except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix No history of tuberculosis No grade 3 local skin toxicity reaction (ulceration) to 5 IU or greater of PPD test No active infections requiring systemic antibiotics, antiviral, or antifungal treatments No serious unstable chronic illnesses No psychological, familial, sociological, or geographical condition that would preclude study
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy with proteins of murine origin At least one month since prior immunotherapy No other concurrent immunotherapy Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: No concurrent chronic use of systemic corticosteroids Radiotherapy: See Disease Characteristics No concurrent radiotherapy including prophylactic cranial irradiation No prior spleen radiotherapy Surgery: No prior surgery for SCLC No prior splenectomy Other: No prior second-line therapy for SCLC At least one month since prior investigational agents No concurrent chronic use of systemic antihistamines or nonsteroidal anti-inflammatory drugs No concurrent immunosuppressive therapy
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Giuseppe Giaccone, MD, PhD
Role: STUDY_CHAIR
Free University Medical Center
Locations
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Scripps Clinic and Research Foundation - La Jolla
La Jolla, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Colorado Permanente Medical Group, P.C.
Denver, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Greenwich Hospital Association
Greenwich, Connecticut, United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States
Norwich Cancer Center
Norwich, Connecticut, United States
Bennett Cancer Center
Stamford, Connecticut, United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, United States
Memorial Regional Cancer Center
Hollywood, Florida, United States
Mercy Hospital
Miami, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Columbia - HCA Cancer Research Network
North Miami Beach, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Georgia Cancer Specialists
Decatur, Georgia, United States
Veterans Affairs Medical Center - West Roxbury
West Roxbury, Massachusetts, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Benefis Healthcare
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Southwest Cancer Clinic
Las Vegas, Nevada, United States
University of Nevada - Reno
Reno, Nevada, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Akron City Hospital
Akron, Ohio, United States
Christ Hospital
Cincinnati, Ohio, United States
Oklahoma Oncology Inc.
Tulsa, Oklahoma, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Royal Prince Alfred Hospital, Sydney
Camperdown, New South Wales, Australia
Repatriation General Hospital
Concord, New South Wales, Australia
Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, Australia
Nepean Hospital
Penrith, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
NSW Breast Cancer Institute
Westmead, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Center
East Bentweigh, Victoria, Australia
Peter MacCallum Cancer Institute
East Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Pulmologisches Zentrum Der Stadt Wien
Vienna (Wein), , Austria
U.Z. Gasthuisberg
Leuven, , Belgium
Universitaetsklinikum Benjamin Franklin
Berlin, , Germany
Asklepios Fachkliniken Munchen- Gauting
Gauting, Munich (Munchen), , Germany
Hospital Grosshansdorf
Großhansdorf, , Germany
Thoraxklinik Rohrbach
Heidelberg, , Germany
Marienhospital/Ruhr University Bochum
Herne, , Germany
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, , Netherlands
Academisch Ziekenhuis der Vrije Universiteit
Amsterdam, , Netherlands
Ziekenhuis St Jansdal
Harderwijk, , Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, , Netherlands
Twee Steden Ziekenhuis Vestiging Tilburg
Tilburg, , Netherlands
Green Lane Hospital
Auckland, , New Zealand
Wellington Cancer Centre
Wellington, , New Zealand
Hospital de Cruces
Barakaldo, Bilbao, , Spain
Hospital de la Santa Cruz I Sant Pau
Barcelona, , Spain
Ciudad Sanitaria Vall D'Hebron
Barcelona, , Spain
Hospital Clinic y Provincial de Barcelona
Barcelona, , Spain
Hospital Nostra Senora Aranzazu
Donostia / San Sebastian, , Spain
Hospital Universitario de Elche
Elche, , Spain
Hospital de la Princesa
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario LA FE
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital General Universitario Valencia
Valencia, , Spain
Hospital Arnau Vilanova
Valencia, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
University Hospital
Basel, , Switzerland
Inselspital, Bern
Bern, , Switzerland
Ratisches Kantons und Regionalspital
Chur, , Switzerland
Kantonsspital - Saint Gallen
Sankt Gallen, , Switzerland
Royal Marsden Hospital
Sutton, England, United Kingdom
Countries
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References
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Bottomley A, Debruyne C, Felip E, Millward M, Thiberville L, D'Addario G, Rome L, Zatloukal P, Coens C, Giaccone G. Symptom and quality of life results of an international randomised phase III study of adjuvant vaccination with Bec2/BCG in responding patients with limited disease small-cell lung cancer. Eur J Cancer. 2008 Oct;44(15):2178-84. doi: 10.1016/j.ejca.2008.06.036.
Other Identifiers
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EORTC-08971
Identifier Type: -
Identifier Source: secondary_id
UCLA-9902001
Identifier Type: -
Identifier Source: secondary_id
EORTC-08971
Identifier Type: -
Identifier Source: org_study_id
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