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

OBJECTIVES:

• 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.

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