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The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG

Phase 3
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG


- 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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Giuseppe Giaccone, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Free University Medical Center


United States: Federal Government

Study ID:




Start Date:

September 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma