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Sponsors and Collaborators: |
ImClone Systems Merck KGaA EORTC Lung Cancer Cooperative Group Spanish Lung Cancer Group Schweizerische Arbeitsgruppe fuer angewandte Krebsforschung (SAKK) Centers of Veterans' Administration Groupe Francais De Pneumo-Cancerologie Memorial Sloan-Kettering Cancer Center Independent centers (Australia, New Zealand, Europe, USA) |
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Information provided by: | ImClone Systems |
ClinicalTrials.gov Identifier: | NCT00037713 |
This trial is designed to test the impact of adjuvant BEC2 (2.5 mg)/BCG vaccination on survival in patients with LD Small Cell Lung Cancer (SCLC). Patients will be stratified by institution, KPS (60 - 70% vs 80 - 100%), and response to first line combined modality therapy (CR vs PR) that consisted of at least a 2 drug regimen (4 - 6 cycles) and a chest radiotherapy regimen. Patients will be randomized to one of two treatment arms: standard arm (Observational cohort) or best supportive care, or the treatment arm (5 intradermal vaccinations of BEC2 (2.5 mg) + BCG given on day 1 of weeks 0, 2, 4, 6, and 10.
Condition | Intervention | Phase |
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Carcinoma, Small Cell Lung |
Biological: BEC2 Vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG |
Enrollment: | 515 |
Study Start Date: | September 1998 |
Study Completion Date: | October 2002 |
Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Best supportive care, but no cancer specific therapy (cytotoxic, radiation or other tumor reductive therapy) can be given until documented progression of disease.
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2: Experimental
Treatment will consist of 5 vaccinations (each consisting of 8 single intradermal injections) over a period of 10 to 12 weeks unless one of the following occur:
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Biological: BEC2 Vaccine
5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 & 10.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | ImClone Systems Incorporated ( Eric Rowinsky/ Chief Medical Officer ) |
Study ID Numbers: | SILVA EORTC 08971 |
Study First Received: | May 20, 2002 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00037713 |
Health Authority: | United States: Food and Drug Administration |
LD Small Cell Lung Cancer BEC2, vaccine adjuvant, monoclonal antibody LD Small Cell Lung Cancer (VA Classification, Zelen, 1973) |
Thoracic Neoplasms Carcinoma, Neuroendocrine Carcinoma Neuroendocrine Tumors Antibodies, Monoclonal Carcinoma, Small Cell Neuroectodermal Tumors Antibodies |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Immunoglobulins Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Neoplasms, Nerve Tissue |