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Monoclonal Antibody Therapy Plus BCG in Treating Patients With Limited-Stage Small Cell Lung Cancer

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: NCT00006352
Recruitment Status : Completed
First Posted : July 28, 2003
Last Update Posted : July 18, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. BCG may activate the immune system to kill tumor cells. Combining monoclonal antibody therapy with BCG may kill more tumor cells. It is not yet known if monoclonal antibody therapy plus BCG is an effective treatment for limited-stage small cell lung cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of monoclonal antibody therapy plus BCG in treating patients who have limited-stage small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: BCG vaccine Biological: monoclonal antibody BEC2 Phase 3

Detailed Description:


  • Determine the impact of vaccination with adjuvant BCG and monoclonal antibody BEC2 on the survival of patients with limited stage small cell lung cancer.
  • Determine the progression free survival in these patients after receiving this treatment regimen.
  • Determine the safety of this treatment regimen in these patients.
  • Assess the quality of life in these patients treated with this regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, Karnofsky performance status (60-70% vs 80-100%), and response to first line combined modality treatment (complete remission vs partial remission). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive vaccination with BCG and monoclonal antibody BEC2 intradermally on day 1 of weeks 0, 2, 4, 6, and 10 in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive no further therapy. Quality of life is assessed at baseline; at weeks 6, 12, and 24; and every 6 months thereafter until disease progression.

Patients are followed at 6 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 570 patients (285 per treatment arm) will be accrued for this study within 2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 453 participants
Allocation: Randomized
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 1999
Actual Primary Completion Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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


  • Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC)

    • Completed first line combination treatment consisting of at least a 2 drug chemotherapy regimen (4 to 6 courses) and a chest radiotherapy regimen

      • Must have achieved clinical response (complete or partial) with no evidence of progression or relapse



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • WBC greater than 3,000/mm^3
  • Platelet count greater than 100,000/mm^3


  • AST less than 1.5 times upper limit of normal
  • No hepatitis B


  • Not specified


  • No history of tuberculosis
  • Purified Protein Derivative negative to at least 5 IU
  • HIV negative
  • No severe active infection
  • No active infections requiring systemic antibiotics, antiviral, or antifungal treatments
  • No serious unstable chronic illness
  • No other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer
  • No psychological, familial, sociological, or geographical condition that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • No prior therapy with mouse proteins
  • No other concurrent immunotherapy before first disease progression


  • See Disease Characteristics
  • No concurrent chemotherapy before first disease progression

Endocrine therapy:

  • No concurrent systemic or chronic corticosteroids


  • See Disease Characteristics
  • No prior radiation to spleen
  • No concurrent radiotherapy before first disease progression


  • No prior surgery for SCLC
  • No prior splenectomy


  • At least 4 weeks since prior combination therapy
  • No prior second line therapy for SCLC
  • At least 4 weeks since other prior investigational agent
  • No concurrent systemic antihistamines or nonsteroidal antiinflammatory drugs
  • No concurrent immunosuppressant therapy before first disease progression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006352

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Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 1001HV
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Giuseppe Giaccone, MD, PhD Free University Medical Center

Publications of Results:
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00006352    
Other Study ID Numbers: EORTC-08971B
First Posted: July 28, 2003    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
limited stage small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic