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

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 3,000/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- AST less than 1.5 times upper limit of normal

- No hepatitis B

Renal:

- Not specified

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy

- No prior therapy with mouse proteins

- No other concurrent immunotherapy before first disease progression

Chemotherapy:

- See Disease Characteristics

- No concurrent chemotherapy before first disease progression

Endocrine therapy:

- No concurrent systemic or chronic corticosteroids

Radiotherapy:

- See Disease Characteristics

- No prior radiation to spleen

- No concurrent radiotherapy before first disease progression

Surgery:

- No prior surgery for SCLC

- No prior splenectomy

Other:

- 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