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 antibody BEC2 and BCG with that of no further therapy in treating patients who have limited-stage small cell lung cancer.

Condition	Treatment or Intervention	Phase
limited stage small cell lung cancer Quality of Life	Drug: BCG  Drug: carboplatin  Drug: cisplatin  Drug: cyclophosphamide  Drug: doxorubicin  Drug: etoposide  Drug: monoclonal antibody BEC2	Phase III

Further Study Details: 

OBJECTIVES: I. Determine the impact of adjuvant therapy consisting of vaccination with mouse anti-GD3 antibody BEC2 and bacille Calmette-Guerin (BCG) on survival of patients with limited stage small cell lung cancer after induction therapy.

II. Determine the safety of this therapy in these patients.

III. Determine the effect of this therapy on progression free survival and quality of life of these patients.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to institution, Karnofsky performance status (60-70% vs 80-100%), induction therapy, radiation (concurrent vs sequential), and response to induction therapy.

Patients receive induction chemotherapy for 4-6 courses consisting of: Intravenous cisplatin on day 1 plus etoposide on days 1, 2, and 3 OR Intravenous carboplatin on day 1 plus etoposide on days 1, 2, and 3 OR Intravenous cyclophosphamide plus doxorubicin on day 1 plus etoposide on days 1, 2, and 3

All patients receive chest radiotherapy, either concurrently or sequentially, with induction chemotherapy.

Within 6 weeks of completing induction therapy, responding patients are randomized to 1 of 2 treatment arms.

Arm I: Patients are observed in this cohort until disease progression is documented.

Arm II: Patients receive intradermal injections of BEC2 and bacille Calmette-Guerin (BCG) on the first day of weeks 0, 2, 4, 6, and 10. Treatment consists of 5 vaccinations over a period of 10 to 12 weeks unless unacceptable toxic effects or disease progression is observed.

Quality of life is assessed prior to vaccination, at weeks 6, 12, and 24, and every 6 months thereafter.

Patients are followed every 3 months until death.

PROJECTED ACCRUAL: Approximately 820 patients will be accrued.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically proven limited stage small cell lung cancer

--Prior/Concurrent Therapy--

• Biologic therapy: No prior immunotherapy within 1 month of study; No other concurrent immunotherapy
• Chemotherapy: No prior chemotherapy for small cell lung cancer (SCLC); No concurrent chemotherapy
• Endocrine therapy: No concurrent systemic corticosteroid therapy; No concurrent immunosuppressive therapy
• Radiotherapy: No prior radiotherapy for SCLC; No concurrent radiotherapy; No prior spleen radiotherapy
• Surgery: No prior surgery for SCLC; No prior splenectomy
• Other: No prior therapy with proteins of murine origin; No prior investigational agents within 1 month of study; No chronic use of antihistamines or nonsteroidal anti-inflammatory drugs; No concurrent antiviral, antibiotic, or antifungal therapies

--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 (ULN)
• Renal: Adequate renal functions
• Other: Not HIV positive; Not pregnant or lactating; 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 severe active infections (e.g., hepatitis B) or unstable chronic illnesses; Fit enough to receive chemotherapy and radiotherapy treatments

Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States
Arizona
      Mayo Clinic Scottsdale, Scottsdale,  Arizona,  85259,  United States
California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      Scripps Clinic and Research Foundation - La Jolla, La Jolla,  California,  92037,  United States
Colorado
      Colorado Permanente Medical Group, P.C., Denver,  Colorado,  80205,  United States
Connecticut
      Bennett Cancer Center, Stamford,  Connecticut,  06902,  United States
      Bridgeport Hospital, Bridgeport,  Connecticut,  06610,  United States
      Greenwich Hospital Association, Greenwich,  Connecticut,  06830,  United States
      Norwich Cancer Center, Norwich,  Connecticut,  06360,  United States
      St. Francis Hospital and Medical Center, Hartford,  Connecticut,  06105,  United States
District of Columbia
      Veterans Affairs Medical Center - Washington, DC, Washington,  District of Columbia,  20422,  United States
Florida
      Columbia - HCA Cancer Research Network, North Miami Beach,  Florida,  33180,  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
Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States
      Georgia Cancer Specialists, Decatur,  Georgia,  30033,  United States
Massachusetts
      Veterans Affairs Medical Center - West Roxbury, West Roxbury,  Massachusetts,  02132,  United States
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
Montana
      Benefis Healthcare, Great Falls,  Montana,  59403,  United States
      Great Falls Clinic, Great Falls,  Montana,  59405,  United States
Nevada
      Southwest Cancer Clinic, Las Vegas,  Nevada,  89119,  United States
      University of Nevada - Reno, Reno,  Nevada,  89520,  United States
New Jersey
      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07018-1095,  United States
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      Veterans Affairs Medical Center - Buffalo, Buffalo,  New York,  14215,  United States
North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
Ohio
      Akron City Hospital, Akron,  Ohio,  44309,  United States
      Christ Hospital, Cincinnati,  Ohio,  45219,  United States
Oklahoma
      Oklahoma Oncology Inc., Tulsa,  Oklahoma,  74104,  United States
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States
Texas
      Joe Arrington Cancer Research and Treatment Center, Lubbock,  Texas,  79410-1894,  United States
West Virginia
      Charleston Area Medical Center, Charleston,  West Virginia,  25304,  United States
Wisconsin
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792,  United States
Australia, New South Wales
      Nepean Hospital, Penrith,  New South Wales,  2750,  Australia
      Newcastle Mater Misericordiae Hospital, Newcastle,  New South Wales,  NSW 2310,  Australia
      NSW Breast Cancer Institute, Westmead,  New South Wales,  2145,  Australia
      Repatriation General Hospital, Concord,  New South Wales,  2139,  Australia
      Royal North Shore Hospital, St. Leonards,  New South Wales,  2065,  Australia
      Royal Prince Alfred Hospital, Sydney, Camperdown,  New South Wales,  2050,  Australia
Australia, South Australia
      Royal Adelaide Hospital, Adelaide,  South Australia,  5000,  Australia
Australia, Victoria
      Monash Medical Center, East Bentweigh,  Victoria,  3165,  Australia
      Peter MacCallum Cancer Institute, East Melbourne,  Victoria,  8006,  Australia
      Royal Melbourne Hospital, Parkville,  Victoria,  3050,  Australia
Australia, Western Australia
      Royal Perth Hospital, Perth,  Western Australia,  6000,  Australia
Austria
      Pulmologisches Zentrum Der Stadt Wien, Vienna (Wein),  A-1145,  Austria
Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium
Germany
      Asklepios Fachkliniken Munchen- Gauting, Gauting, Munich (Munchen),  DOH-8-2131,  Germany
      Hospital Grosshansdorf, Grosshansdorf,  D-22927,  Germany
      Marienhospital/Ruhr University Bochum, Herne,  DOH-4-4625,  Germany
      Thoraxklinik Rohrbach, Heidelberg,  D-69126,  Germany
      Universitaetsklinikum Benjamin Franklin, Berlin,  D-12200,  Germany
Netherlands
      Academisch Ziekenhuis der Vrije Universiteit, Amsterdam,  1007 MB,  Netherlands
      Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch,  5211 NL,  Netherlands
      Sint Antonius Ziekenhuis, Nieuwegein,  3435 CM,  Netherlands
      Twee Steden Ziekenhuis Vestiging Tilburg, Tilburg,  5042 AD,  Netherlands
      Ziekenhuis St Jansdal, Harderwijk,  3840 AC,  Netherlands
New Zealand
      Green Lane Hospital, Auckland,  3,  New Zealand
      Wellington Cancer Centre, Wellington,  6039,  New Zealand
Spain
      Ciudad Sanitaria Vall D'Hebron, Barcelona,  08035,  Spain
      Hospital Arnau Vilanova, Valencia,  46015,  Spain
      Hospital Clinic y Provincial de Barcelona, Barcelona,  08036,  Spain
      Hospital Clinico Universitario de Valencia, Valencia,  46010,  Spain
      Hospital de Cruces, Barakaldo, Bilbao,  E-48903,  Spain
      Hospital de la Princesa, Madrid,  28006,  Spain
      Hospital de la Santa Cruz I Sant Pau, Barcelona,  08025,  Spain
      Hospital General Universitario Valencia, Valencia,  46014,  Spain
      Hospital Miguel Servet, Zaragoza,  50009,  Spain
      Hospital Nostra Senora Aranzazu, San Sebastian,  Spain
      Hospital Universitario 12 de Octubre, Madrid,  28041,  Spain
      Hospital Universitario de Elche, Elche,  E-03203,  Spain
      Hospital Universitario LA FE, Valencia,  46009,  Spain
Switzerland
      Inselspital, Bern, Bern,  CH-3010,  Switzerland
      Kantonsspital - Saint Gallen, Saint Gallen,  CH-9007,  Switzerland
      Ratisches Kantons und Regionalspital, Chur,  CH-7000,  Switzerland
      University Hospital, Basel,  CH-4031,  Switzerland
United Kingdom, England
      Royal Marsden Hospital, Sutton,  England,  SM2 5PT,  United Kingdom

Study chairs or principal investigators

Giuseppe Giaccone,  Study Chair,  EORTC Lung Cancer Cooperative Group   

Study ID Numbers:  CDR0000066185; EORTC-08971; EORTC-08971B; UCLA-9902001
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003279
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08