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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

This study has been completed.
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)
Information provided by:
ImClone LLC Identifier:
First received: May 20, 2002
Last updated: April 7, 2010
Last verified: April 2010
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
Carcinoma, Small Cell Lung
Biological: BEC2 Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by ImClone LLC:

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 ]

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
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information


Responsible Party: Chief Medical Officer, ImClone LLC Identifier: NCT00037713     History of Changes
Other Study ID Numbers: SILVA EORTC 08971
Study First Received: May 20, 2002
Last Updated: April 7, 2010

Keywords provided by ImClone LLC:
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
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017