Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG
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ClinicalTrials.gov Identifier: NCT00037713 |
Recruitment Status :
Completed
First Posted : May 21, 2002
Last Update Posted : April 8, 2010
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Sponsor:
Eli Lilly and Company
Collaborators:
Merck KGaA, Darmstadt, Germany
EORTC Lung Cancer Cooperative Group
Spanish Lung Cancer Group
Schweizerische Arbeitsgruppe fuer angewandte Krebsforschung (SAKK)
US Department of Veterans Affairs
Groupe Francais De Pneumo-Cancerologie
Memorial Sloan Kettering Cancer Center
Independent centers (Australia, New Zealand, Europe, USA)
Information provided by:
Eli Lilly and Company
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma, Small Cell Lung | Biological: BEC2 Vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 515 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | September 1998 |
Actual Primary Completion Date : | October 2002 |
Actual Study Completion Date : | October 2002 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Lung cancer
Arm | Intervention/treatment |
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No Intervention: 1
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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Experimental: 2
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. |
Primary Outcome Measures :
- Overall survival [ Time Frame: 6 monthly basis until progression of disease ]
Secondary Outcome Measures :
- Progression-free survival [ Time Frame: 6 monthly basis until progression of disease ]
- Safety [ Time Frame: 6 monthly basis until progression of disease ]
- Quality of Life [ Time Frame: 6 monthly basis until progression of disease ]
- Health Economics Aspects [ Time Frame: 6 monthly basis until progression of disease ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histo-cytologically proven SCLC
- Limited disease at diagnosis
- Age greater than or equal to 18
- Patients with a clinical response of CR or PR to first line combined modality therapy
- KPS greater than or equal to 60
- Adequate bone marrow, liver and heart functions
- Written informed Consent
Exclusion Criteria:
- Prior surgical treatment for SCLC
- History of tuberculosis
- NCIC CTG grade 3 local skin toxicity reaction (ulceration) to > IU PPD test > 5 IU
- HIV positive
- Splenectomy or spleen radiation therapy in medical history
- Prior therapy to proteins of murine origin
- Any second line therapy for SCLC
- Investigational agent or immune therapy within 4 weeks prior to study randomization
- Severe active infections
- Active infections requiring systemic antibiotics, antiviral, or antifungal treatments
- Serious unstable chronic illness
- The use of systemic anti-histamines, NSAID or systemic corticosteroids
- Any previous malignancy except adequately treated CIS of the cervix or non melanoma skin cancer or if previous malignancy was more than 5 years prior and there are no signs of recurrence
- Pregnancy or breast feeding or absence of adequate contraception for fertile patients
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before randomization in the trial.
No Contacts or Locations Provided
Publications:
Responsible Party: | Chief Medical Officer, ImClone LLC |
ClinicalTrials.gov Identifier: | NCT00037713 |
Other Study ID Numbers: |
SILVA EORTC 08971 |
First Posted: | May 21, 2002 Key Record Dates |
Last Update Posted: | April 8, 2010 |
Last Verified: | April 2010 |
Keywords provided by Eli Lilly and Company:
LD Small Cell Lung Cancer BEC2, vaccine adjuvant, monoclonal antibody LD Small Cell Lung Cancer (VA Classification, Zelen, 1973) |
Additional relevant MeSH terms:
Lung Neoplasms Small Cell Lung Carcinoma Carcinoma, Small Cell Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |