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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-08971 | |||
| UCLA-9902001 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCG vaccine | Biological | |||
| monoclonal antibody BEC2 | Biological |
DISEASE CHARACTERISTICS: Histologically or cytologically proven limited stage small cell lung cancer (SCLC) Must have completed adequate first-line combined modality treatment comprising at least 4-6 courses of a 2-drug chemotherapy regimen and chest radiotherapy No evidence of disease progression or relapse Disease response (complete or partial) after treatment
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
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Giaccone, MD, PhD | Universitair Ziekenhuis Brussel | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Comprehensive Cancer Center | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic Scottsdale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18676140 | Result | 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. |
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| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Scripps Clinic and Research Foundation - La Jolla | La Jolla | California | 92037 | United States |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | 90095-1781 | United States |
| Colorado Permanente Medical Group, P.C. | Denver | Colorado | 80205 | United States |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States |
| Greenwich Hospital Association | Greenwich | Connecticut | 06830 | United States |
| St. Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
| Norwich Cancer Center | Norwich | Connecticut | 06360 | United States |
| Bennett Cancer Center | Stamford | Connecticut | 06902 | United States |
| Veterans Affairs Medical Center - Washington, DC | Washington D.C. | District of Columbia | 20422 | United States |
| Memorial Regional Cancer Center | Hollywood | Florida | 33021 | United States |
| Mercy Hospital | Miami | Florida | 33133 | United States |
| Sylvester Cancer Center, University of Miami | Miami | Florida | 33136 | United States |
| Columbia - HCA Cancer Research Network | North Miami Beach | Florida | 33180 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Georgia Cancer Specialists | Decatur | Georgia | 30033 | United States |
| Veterans Affairs Medical Center - West Roxbury | West Roxbury | Massachusetts | 02132 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Benefis Healthcare | Great Falls | Montana | 59403 | United States |
| Great Falls Clinic | Great Falls | Montana | 59405 | United States |
| Southwest Cancer Clinic | Las Vegas | Nevada | 89119 | United States |
| University of Nevada - Reno | Reno | Nevada | 89520 | United States |
| Veterans Affairs Medical Center - East Orange | East Orange | New Jersey | 07018-1095 | United States |
| Veterans Affairs Medical Center - Buffalo | Buffalo | New York | 14215 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| Akron City Hospital | Akron | Ohio | 44309 | United States |
| Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Oklahoma Oncology Inc. | Tulsa | Oklahoma | 74104 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410-1894 | United States |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792 | United States |
| Royal Prince Alfred Hospital, Sydney | Camperdown | New South Wales | 2050 | Australia |
| Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| Newcastle Mater Misericordiae Hospital | Newcastle | New South Wales | NSW 2310 | Australia |
| Nepean Hospital | Penrith | New South Wales | 2750 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| NSW Breast Cancer Institute | Westmead | New South Wales | 2145 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Monash Medical Center | East Bentweigh | Victoria | 3165 | Australia |
| Peter MacCallum Cancer Institute | East Melbourne | Victoria | 8006 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Pulmologisches Zentrum Der Stadt Wien | Vienna (Wein) | A-1145 | Austria |
| U.Z. Gasthuisberg | Leuven | B-3000 | Belgium |
| Universitaetsklinikum Benjamin Franklin | Berlin | D-12200 | Germany |
| Asklepios Fachkliniken Munchen- Gauting | Gauting, Munich (Munchen) | DOH-8-2131 | Germany |
| Hospital Grosshansdorf | Großhansdorf | D-22927 | Germany |
| Thoraxklinik Rohrbach | Heidelberg | D-69126 | Germany |
| Marienhospital/Ruhr University Bochum | Herne | DOH-4-4625 | Germany |
| Groot Ziekengasthuis 's-Hertogenbosch | 's-Hertogenbosch | 5211 NL | Netherlands |
| Academisch Ziekenhuis der Vrije Universiteit | Amsterdam | 1007 MB | Netherlands |
| Ziekenhuis St Jansdal | Harderwijk | 3840 AC | Netherlands |
| Sint Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| Twee Steden Ziekenhuis Vestiging Tilburg | Tilburg | 5042 AD | Netherlands |
| Green Lane Hospital | Auckland | 3 | New Zealand |
| Wellington Cancer Centre | Wellington | 6039 | New Zealand |
| Hospital de Cruces | Barakaldo, Bilbao | E-48903 | Spain |
| Hospital de la Santa Cruz I Sant Pau | Barcelona | 08025 | Spain |
| Ciudad Sanitaria Vall D'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic y Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Nostra Senora Aranzazu | Donostia / San Sebastian | Spain |
| Hospital Universitario de Elche | Elche | E-03203 | Spain |
| Hospital de la Princesa | Madrid | 28006 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario LA FE | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital General Universitario Valencia | Valencia | 46014 | Spain |
| Hospital Arnau Vilanova | Valencia | 46015 | Spain |
| Hospital Miguel Servet | Zaragoza | 50009 | Spain |
| University Hospital | Basel | CH-4031 | Switzerland |
| Inselspital, Bern | Bern | CH-3010 | Switzerland |
| Ratisches Kantons und Regionalspital | Chur | CH-7000 | Switzerland |
| Kantonsspital - Saint Gallen | Sankt Gallen | CH-9007 | Switzerland |
| Royal Marsden Hospital | Sutton | England | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001500 | BCG Vaccine |
| ID | Term |
|---|---|
| D032581 | Tuberculosis Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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