Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG

Study Overview
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Brief Summary
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This trial is designed to test the impact of adjuvant BEC2 (2.5 mg)/BCG vaccination on survival in patients with LD Small Cell Lung Cancer (SCLC). Patients will be stratified by institution, KPS (60 - 70% vs 80 - 100%), and response to first line combined modality therapy (CR vs PR) that consisted of at least a 2 drug regimen (4 - 6 cycles) and a chest radiotherapy regimen. Patients will be randomized to one of two treatment arms: standard arm (Observational cohort) or best supportive care, or the treatment arm (5 intradermal vaccinations of BEC2 (2.5 mg) + BCG given on day 1 of weeks 0, 2, 4, 6, and 10.

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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Carcinoma, Small Cell Lung

Intervention / Treatment
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* Biological: BEC2 Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histo-cytologically proven SCLC Limited disease at diagnosis Age greater than or equal to 18 Patients with a clinical response of CR or PR to first line combined modality therapy KPS greater than or equal to 60 Adequate bone marrow, liver and heart functions Written informed Consent Exclusion Criteria: Prior surgical treatment for SCLC History of tuberculosis NCIC CTG grade 3 local skin toxicity reaction (ulceration) to > IU PPD test > 5 IU HIV positive Splenectomy or spleen radiation therapy in medical history Prior therapy to proteins of murine origin Any second line therapy for SCLC Investigational agent or immune therapy within 4 weeks prior to study randomization Severe active infections Active infections requiring systemic antibiotics, antiviral, or antifungal treatments Serious unstable chronic illness The use of systemic anti-histamines, NSAID or systemic corticosteroids Any previous malignancy except adequately treated CIS of the cervix or non melanoma skin cancer or if previous malignancy was more than 5 years prior and there are no signs of recurrence Pregnancy or breast feeding or absence of adequate contraception for fertile patients Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before randomization in the trial.

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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Best supportive care, but no cancer specific therapy (cytotoxic, radiation or other tumor reductive therapy) can be given until documented progression of disease. | |
| Experimental: 2<br>Treatment will consist of 5 vaccinations (each consisting of 8 single intradermal injections) over a period of 10 to 12 weeks unless one of the following occur: intolerable toxicity precluding further treatment progression of disease patient refusal occurrence of pregnancy | Biological: BEC2 Vaccine<br>* 5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 & 10.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 6 monthly basis until progression of disease | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 6 monthly basis until progression of disease | 
| Safety |  | 6 monthly basis until progression of disease | 
| Quality of Life |  | 6 monthly basis until progression of disease | 
| Health Economics Aspects |  | 6 monthly basis until progression of disease | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BEC2, vaccine, LD Small Cell Lung Cancer, adjuvant, monoclonal antibody, LD Small Cell Lung Cancer (VA Classification, Zelen, 1973)