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Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00037713
Recruitment Status : Completed
First Posted : May 21, 2002
Last Update Posted : April 8, 2010
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

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

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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

Arm Intervention/treatment
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.
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:

  1. intolerable toxicity precluding further treatment progression of disease
  2. patient refusal
  3. occurrence of pregnancy
Biological: BEC2 Vaccine
5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 & 10.

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 6 monthly basis until progression of disease ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 6 monthly basis until progression of disease ]
  2. Safety [ Time Frame: 6 monthly basis until progression of disease ]
  3. Quality of Life [ Time Frame: 6 monthly basis until progression of disease ]
  4. Health Economics Aspects [ Time Frame: 6 monthly basis until progression of disease ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Chief Medical Officer, ImClone LLC 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:
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Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type