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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: BCG vaccine
* Biological: monoclonal antibody BEC2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: BCG vaccine|nan|
|Biological: monoclonal antibody BEC2|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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limited stage small cell lung cancer